Patients will have a short “window‑of‑opportunity” period during which a small tissue sample (biopsy) is taken before the first infusion and another after the initial dose to look at immune biomarkers, which are signals that indicate how the immune system is reacting. After this phase, regular infusions continue, and doctors perform routine scans and blood tests to monitor the disease. Outcomes such as how long the cancer stays stable without growing (progression-free survival), how many patients see their tumors shrink (overall response rate), and the presence of tumor DNA fragments in the blood (ctDNA) are recorded. Additional laboratory analyses may examine genetic markers like HLA, immune‑activating proteins such as IFN-γ, the presence of immune cells marked by CD8, and the level of a protein called PD-L1 using a staining technique known as IHC. Safety is also closely watched through regular health checks and reporting of any side effects.

The purpose of the study is to see whether daily treatment with elafibranor can delay serious health problems such as death, the need for liver transplantation, worsening liver function known as hepatic decompensation, high blood pressure in the liver’s blood vessels called portal hypertension, and other complications related to the bile ducts, referred to as cholangiopathy. Participants will be randomly assigned to receive either the active drug or the placebo and will be followed for several years, with regular visits to check their health and any events that occur.

The trial lasts for a few years, during which participants continue their usual care while taking the study medication or placebo. Information on safety and any health events will be collected at each visit, and the overall goal is to determine if the drug can safely improve outcomes for adults living with this condition.

The aim of the trial is to find out how well REC-4881 works and how safe it is for people with this condition. Participants will take the study medication or placebo for several months, with regular visits to have blood tests that look at the drug’s pharmacokinetics—how the body absorbs and clears the medicine—and to check for any side effects. Doctors will also perform examinations of the colon to see how the number and size of polyps, known as polyp burden, change over time.

The purpose of the study is to find out if letting patients control their own sedation with remimazolam is safer and leads to higher satisfaction than when the doctor controls the sedation using either remimazolam or midazolam. Participants will be randomly assigned to one of the three groups, receive the assigned medication through an injection, and either manage the dose themselves using a simple device or have the dose given by the physician. The study follows each person through the colonoscopy, monitors for any moderate or severe side effects (known as adverse events), records how quickly they can leave the clinic (discharge), and asks about their overall experience to measure satisfaction.

The purpose is to determine whether allowing patients to choose their treatment reduces feelings of regret about that choice after twelve months. Participants are randomly placed into either the choice group or the surgery‑only group, receive the assigned treatment, and are followed for about a year with regular check‑ups.

During follow‑up, patients answer questions about any regret regarding the initial treatment, report any return of symptoms, and complete a questionnaire about overall quality of life. This information is used to compare the outcomes of the two treatment strategies.

The purpose of the study is to assess how well Mirikizumab works in treating these diseases over an extended period. Participants in the study will receive the medication and be monitored to see how their symptoms change over time. The study will look at whether the medication helps achieve clinical remission, which means a significant reduction or disappearance of symptoms, in participants with either Ulcerative Colitis or Crohn’s Disease.

Throughout the study, participants will receive regular injections of Mirikizumab and will have follow-up visits to track their progress. The study aims to provide valuable information on the long-term use of Mirikizumab in young patients with these chronic conditions, helping to determine its potential benefits and any side effects that may occur during treatment.

Table of Contents

• Trial overview
• Who can participate
• What is being measured
• Study design and phase
• What the study may mean for patients

Trial overview

The clinical trial with ID 2025-524719-35-00 is a study of MB-001 in adults with moderate to severe ulcerative colitis.^[1] It is an interventional study, which means researchers give a treatment and then measure the results.^[1] The study is authorised and plans to enroll 100 participants.^[1]

Who can participate

The trial is for adults with moderately to severely active ulcerative colitis.^[1] The source data do not list more detailed entry rules, so the available information only confirms the condition, age group, and disease activity level.^[1]

What is being measured

The main safety measures include the number of adverse events, treatment-emergent adverse events, serious adverse events, adverse events of special interest, and treatment stopping because of treatment-emergent adverse events through Week 12.^[1] The study also checks changes in laboratory tests, physical examination findings, and vital signs through Week 12.^[1]

The main efficacy measure is the proportion of participants who reach clinical remission at Week 12.^[1] In this study, clinical remission is defined by a modified Mayo Score of 2 or less, a Mayo endoscopic subscore of 1 or less, rectal bleeding subscore of 0, and stool frequency subscore of 1 or less.^[1] These scores are used to show how active ulcerative colitis is, with lower scores meaning less disease activity.^[1]

Study design and phase

This is a Phase 1 trial, which is an early stage of testing.^[1] Phase 1 studies usually focus on safety and tolerability, and this trial follows that pattern by also looking for early signs of efficacy, or benefit.^[1] The study compares MB-001 with a placebo, which is a look-alike treatment that has no active ingredient.^[1]

MB-001 is given orally in this trial, meaning it is taken by mouth.^[1] The placebo uses the same formulation excipients as the MB-001 product except for the active ingredient.^[1]

What the study may mean for patients

This study is designed to learn whether MB-001 can be studied safely in people with active ulcerative colitis and whether it may help reduce disease signs.^[1] The key patient-focused outcome is whether more participants can reach remission by Week 12, while also watching for unwanted medical problems during treatment.^[1] Because the trial is early stage, it is mainly about learning and comparison rather than proving long-term benefit.^[1]

Table of Contents

• Trial overview
• Who can participate
• What the study measures
• Trial phase and size
• Study treatments
• Why this trial matters

Trial overview

This is an interventional study, which means researchers give study treatment and then measure the results in participants.^[1] The trial is authorised and is studying adults with moderate to severe Crohn’s disease.^[1]

The study title says it is looking at targeted therapies for treatment of this condition, and the brief summary says the goal is to evaluate safety, efficacy, and the mechanistic profile of the studied therapies.^[1] ABBV-8736 is one of the listed study drugs in this trial.^[1]

Who can participate

The source data show that the target population is adult participants with moderate to severe Crohn’s disease.^[1] No other eligibility details are provided in the trial information given here.^[1]

What the study measures

The main endpoint is endoscopic remission at Week 12.^[1] Endoscopic remission means that a scope exam of the bowel shows little or no active disease.^[1]

The study also aims to assess safety and efficacy.^[1] Safety means watching for problems during the study, while efficacy means how well the treatment works for the disease.^[1]

Trial phase and size

This study is in Phase 2.^[1] Phase 2 trials usually focus on whether a treatment may work and continue to collect safety information.^[1]

The planned enrollment is 1,072 participants.^[1] Enrollment means the number of people the study hopes to include.^[1]

Study treatments

ABBV-8736 is listed among several targeted therapies in the study.^[1] The other listed treatments are ABBV-066, Lutikizumab, ABBV-382, and ABBV-066 with Risankizumab.^[1]

The source data list different ways these study drugs are given, including intravenous use, subcutaneous injection, and intramuscular use.^[1] These are ways medicine can be given into a vein, under the skin, or into a muscle.^[1]

Why this trial matters

People with moderate to severe Crohn’s disease often need treatments that reduce bowel inflammation and improve disease control.^[1] This study is designed to help researchers learn whether ABBV-8736 and the other targeted therapies can help with that goal.^[1]

Because the study measures endoscopic remission, it looks not only at symptoms but also at what is seen directly inside the bowel.^[1] That can give a clearer picture of whether the disease is truly improving.^[1]

Table of Contents

• Trial overview
• Ulcerative colitis study
• Crohn’s disease study
• Who can participate
• What is being measured
• Trial phases and status

Trial overview

These studies are testing ICOTROKINRA in people with inflammatory bowel disease, which is a group of long-term diseases that cause swelling and irritation in the digestive tract.^[1] The trial data show two authorised interventional studies, one in ulcerative colitis and one in Crohn’s disease.^[1][2]

An interventional study means the researchers give a study treatment and compare results with placebo or another study group.^{[1][2] The main goal is to see whether ICOTROKINRA helps people reach clinical remission, clinical response, and other signs of improvement.[1][2]}

Ulcerative colitis study

The ulcerative colitis trial is titled Efficacy and Safety of Icotrokinra in Adult and Adolescent Participants with Moderately to Severely Active Ulcerative Colitis.^[1] It is a Phase 3 study with 882 participants and is currently authorised.^[1]

This study includes three parts: an adult induction study, an adult maintenance study, and an adolescent study.^[1] Induction means the first part of treatment, where researchers check whether the study treatment can bring symptoms under control.^[1] Maintenance means the later part, where researchers check whether the benefit can be kept over time.^[1]

The adult induction part compares ICOTROKINRA with placebo to see if it can induce clinical remission by Week 12.^[1] The adult maintenance part looks at whether remission can be maintained by Week 40 in participants who first had a clinical response with ICOTROKINRA.^[1]

The adolescent part also looks at maintenance and measures clinical remission by Week 40 in adolescents with moderately to severely active ulcerative colitis who first responded to ICOTROKINRA.^[1] This means the study is not only checking short-term improvement, but also whether benefit can last in younger participants.^[1]

Crohn’s disease study

The Crohn’s disease trial is titled Efficacy and Safety of Icotrokinra in Participants with Moderately to Severely Active Crohn’s Disease.^[2] It is an authorised Phase 4 study with 1,090 participants.^[2]

This trial includes a Phase 2b induction part and Phase 3 induction and maintenance parts.^[2] The induction parts study whether ICOTROKINRA can help people improve at Week 12, while the maintenance part studies whether that benefit can continue to Week 40.^[2]

For Phase 3 induction, the co-primary endpoints are clinical remission and endoscopic response at Week 12.^[2] For Phase 3 maintenance, the co-primary endpoints are clinical remission and endoscopic response at Week 40.^[2]

Endoscopic response means the bowel looks better on a scope test, which helps show whether inflammation inside the bowel has improved.^[2]

Who can participate

The ulcerative colitis study includes adult and adolescent participants with moderately to severely active disease.^[1] The Crohn’s disease study includes participants with moderately to severely active Crohn’s disease.^[2]

Based on the trial data, the studies are focused on people whose disease is active enough to need research treatment and close follow-up.^{[1][2] The source data do not give full details about all entry rules, so the exact participation criteria are not listed here.[1][2]}

What is being measured

The main outcome in the ulcerative colitis study is clinical remission at Week 12 for the adult induction part and at Week 40 for the adult and adolescent maintenance parts.^[1] Clinical remission means the disease signs and symptoms are very low or absent.^[1]

The Crohn’s disease study measures clinical response in the Phase 2b induction part at Week 12, and clinical remission plus endoscopic response in the Phase 3 induction and maintenance parts.^[2] A clinical response means the person improves, even if they do not reach full remission.^[2]

These outcomes help researchers understand both symptom improvement and bowel healing over time.^[1][2]

Trial phases and status

The ulcerative colitis study is a Phase 3 trial and is authorised.^[1] Phase 3 studies are usually larger studies that help confirm how well a treatment works.^[1]

The Crohn’s disease study is a Phase 4 trial and is also authorised.^[2] It includes Phase 2b and Phase 3 parts inside the same research program, which allows researchers to study different stages of treatment in one overall trial.^[2]

Across both trials, the focus is on whether ICOTROKINRA can help people with active inflammatory bowel disease reach remission or clear improvement and keep that benefit over time.^[1][2]

Table of Contents

• What is [AL[18F]F]FAPI-74?
• How does [AL[18F]F]FAPI-74 work?
• What conditions is [AL[18F]F]FAPI-74 being studied for?
• How is [AL[18F]F]FAPI-74 administered?
• Potential benefits of [AL[18F]F]FAPI-74
• Ongoing research and clinical trials
• Safety considerations

What is [AL[18F]F]FAPI-74?

[AL[18F]F]FAPI-74 is an innovative diagnostic tool being studied for its potential in detecting various types of cancers^[1]. It is a radioactive tracer used in a special type of imaging called PET/CT (Positron Emission Tomography/Computed Tomography). This substance is also known by other names such as [18F]-AlF-FAPI-74 or simply 18F-FAPI-74^[2].

How does [AL[18F]F]FAPI-74 work?

[AL[18F]F]FAPI-74 works by targeting a specific protein called Fibroblast Activation Protein (FAP). This protein is often found in high amounts in the tissue surrounding various types of tumors. When [AL[18F]F]FAPI-74 is injected into the body, it attaches to these FAP proteins, allowing doctors to see where cancer might be present using a PET/CT scanner^[3].

What conditions is [AL[18F]F]FAPI-74 being studied for?

Research is ongoing to evaluate the effectiveness of [AL[18F]F]FAPI-74 in diagnosing and monitoring several types of cancers, including:

• Progressive Pulmonary Fibrosis (PPF): A condition where the lungs become scarred over time^[1].
• Carcinoma of Unknown Primary (CUP): A type of cancer where doctors can’t determine where the cancer originally started^[2].
• Pancreatic cancer: Cancer that starts in the pancreas^[4].
• Colon cancer: Cancer that begins in the large intestine (colon)^[5].
• Prostate cancer: Cancer that occurs in the prostate gland^[6].
• Biliary tract cancers: Cancers that occur in the bile ducts^[3].

How is [AL[18F]F]FAPI-74 administered?

[AL[18F]F]FAPI-74 is given as a solution for injection. It is typically administered through an intravenous (IV) injection, which means it’s injected directly into a vein^[1][2]. The dose can vary, but studies have used amounts ranging from 250 to 400 MBq (megabecquerels, a unit of radioactivity)^[4][6].

Potential benefits of [AL[18F]F]FAPI-74

The potential benefits of [AL[18F]F]FAPI-74 include:

• Improved detection of cancer spread: It may help doctors identify if cancer has spread to lymph nodes or other parts of the body more accurately than current methods^[4][5].
• Identifying unknown primary tumors: In cases where the origin of cancer is unknown, [AL[18F]F]FAPI-74 might help locate the primary tumor^[2].
• Distinguishing between inflammation and active fibrosis: This could be particularly useful in conditions like pulmonary fibrosis^[1].
• Guiding treatment decisions: By providing more accurate information about a patient’s cancer, it could help doctors make better decisions about treatment^[3].

Ongoing research and clinical trials

Several clinical trials are currently underway to evaluate the effectiveness of [AL[18F]F]FAPI-74 in various cancers. These studies aim to determine:

• The accuracy of [AL[18F]F]FAPI-74 in detecting cancer spread^[4][5].
• How well it performs compared to other imaging techniques^[6].
• Its ability to guide treatment decisions and improve patient outcomes^[3].
• The optimal dose and timing for [AL[18F]F]FAPI-74 PET/CT scans^[1][2].

Safety considerations

While [AL[18F]F]FAPI-74 appears promising, it’s important to note that it’s still being studied and is not yet approved for widespread clinical use. As with any medical procedure involving radiation, there are some safety considerations:

• The procedure exposes patients to a small amount of radiation^[1].
• It’s not recommended for pregnant or breastfeeding women^[3].
• Patients with severely impaired kidney function may need special consideration^[3].
• As with any injection, there’s a small risk of allergic reaction^[3].

Always consult with your healthcare provider to understand the potential risks and benefits of participating in a clinical trial or undergoing any new diagnostic procedure.

Table of contents

• Trial overview
• Who can participate
• Study design and phase
• What is being measured
• Study treatment and comparison
• Why this trial matters

Trial overview

The available clinical trial is a multicenter, randomized, double-blind, comparative clinical trial studying Zinc Acexamate in people with advanced chronic liver disease (cACLD).^[1] The study is designed to check whether Zinc Acexamate can improve prognosis and reduce serious liver-related events during follow-up.^[1]

The trial is authorised and planned for 300 participants.^[1] It is a Phase 3 study, which means it is testing the treatment in a larger group of patients and looking carefully at outcomes.^[1]

Who can participate

The target population in the trial data is patients with chronic liver disease, specifically advanced chronic liver disease (cACLD).^[1] No more detailed inclusion or exclusion rules are provided in the source data, so the main known requirement is the disease group being studied.^[1]

This means the study is focused on adults with more advanced liver disease, rather than on healthy volunteers or people with other conditions.^[1]

Study design and phase

The study uses a randomized design, so participants are assigned by chance to a study group.^[1] This helps make the comparison fair and reduces the chance that the results are influenced by who receives which treatment.^[1]

It is also double-blind, which means neither the participants nor the study team know who is receiving Zinc Acexamate and who is receiving placebo during the trial.^[1] This helps reduce bias, which is when expectations could affect how results are seen or reported.^[1]

The trial is interventional, meaning researchers assign a treatment and then observe the results.^[1] It is being carried out at multiple sites, which can help include a broader patient population and make the results more generalizable.^[1]

What is being measured

The main endpoint is the occurrence of time-dependent clinical events during follow-up.^[1] An endpoint is the main result the researchers use to judge whether the treatment is helping.^[1]

The clinical events being tracked include hepatic decompensation, which the trial defines as clinical ascites, gastrointestinal bleeding due to portal hypertension, and hepatic encephalopathy.^[1] Ascites means fluid buildup in the belly, and hepatic encephalopathy means brain problems caused by liver disease.^[1]

Other events being measured are hepatocellular carcinoma, death from liver causes, and liver transplant.^[1] The trial also looks at the distribution of CSPH risk estimated by the ANTICIPATE model.^[1] CSPH stands for clinically significant portal hypertension, which means important high pressure in the blood flow to the liver.^[1]

Study treatment and comparison

The study compares Zinc Acexamate with a placebo, which is a look-alike treatment without the active substance.^[1] The source data also says the trial uses oral administration and describes the study drug as COPINAL 300 mg capsules at 600 mg per day, equivalent to 100 mg per day of elemental zinc.^[1]

The purpose of this comparison is to see whether Zinc Acexamate leads to fewer serious liver events and a better prognosis than placebo in patients with cACLD.^[1]

Why this trial matters

People with advanced chronic liver disease can face serious outcomes, including liver failure, liver cancer, transplant, or death from liver causes.^[1] This trial is important because it focuses on whether Zinc Acexamate can change those outcomes in a meaningful way.^[1]

Because the study is Phase 3 and uses a placebo comparison, it is designed to give stronger evidence about benefit in a real patient group with advanced liver disease.^[1] The results may help show whether the treatment can lower the risk of major clinical events over time.^[1]

Table of Contents

• Trial overview
• Nutrition after oesophagectomy
• Early versus postponed supplementary parenteral nutrition
• What the trials measure
• Who may take part
• Why Phase 3 matters

Trial overview

The source data does not list a trial directly studying Zinc Sulphate Heptahydrate. Instead, it lists two authorised interventional studies about nutrition support after major surgery.^[1][2]

Both studies are Phase 3 trials, which means they are testing treatments in larger groups of patients and comparing outcomes in real clinical settings.^[1][2]

Nutrition after oesophagectomy

One trial is titled Route of nutrition and muscle wasting after oesophagectomy.^[1] It is a Phase 3 interventional study with 38 planned participants and an authorised status.^[1]

This study aims to understand how the route of nutrition affects cachexia, which means severe weight and muscle loss, after oesophagectomy.^[1]

The intervention listed is SmofKabiven emulsion for infusion, which is given by parenteral use, meaning through a vein rather than by mouth.^[1]

Early versus postponed supplementary parenteral nutrition

The second trial is titled Early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery.^[2] It is also a Phase 3 interventional study and is authorised, with 342 planned participants.^[2]

This study compares early and postponed supplementary parenteral nutrition after major emergency abdominal surgery.^[2] The goal is to see whether one approach lowers the risk of nosocomial infections, which are infections that happen during a hospital stay.^[2]

The interventions listed are SmofKabiven Perifer and SmofKabiven, both given by infusion.^[2]

What the trials measure

The main outcome in the oesophagectomy study is the mean difference in muscle size on CT scan from before surgery to 10 days after surgery.^[1]

This outcome helps researchers see whether nutrition route is linked to less muscle loss after surgery.^[1]

The main outcome in the emergency abdominal surgery study is a reduction in the rate of infectious complications during admission.^[2]

This outcome focuses on whether the timing of supplementary parenteral nutrition affects infection risk while the patient is in hospital.^[2]

Who may take part

The source data shows that the target populations are adults after oesophagectomy and adults after major emergency abdominal surgery.^[1][2]

No additional eligibility details are provided in the source data, such as age limits, lab tests, or medical exclusions.^[1][2]

Why Phase 3 matters

Phase 3 studies are usually used to compare treatment approaches in larger groups and measure important health outcomes.^[1][2]

In these two trials, the researchers are not only looking at whether nutrition support can help, but also at specific recovery results such as muscle size and infection rates.^[1][2]

Table of contents

• Clinical trial overview
• Trials in gastric and gastroesophageal junction cancer
• Trial in pancreatic cancer
• Main endpoints used in the studies
• Who the trials are for
• Study design and comparison groups
• Trial summary table

Clinical trial overview

The clinical trials in this set study Zolbetuximab in people with advanced cancers of the stomach, gastroesophageal junction, and pancreas.^{[1][2][3][4][5][6][7]}

Most studies are interventional, which means the researchers give a treatment and then measure what happens.^{[1][2][3][4][5][6][7]}

The trial phases are mainly Phase 2 and Phase 3, so the program includes both earlier testing and larger confirmatory studies.^{[1][2][3][4][5][6][7]}

Trials in gastric and gastroesophageal junction cancer

Several trials focus on gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma, which is cancer at the point where the esophagus meets the stomach.^[1][4][5][7]

NCT03504397 is a Phase 3 study in people with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, and it compares Zolbetuximab plus mFOLFOX6 with placebo plus mFOLFOX6 as first-line treatment.^[4]

NCT03653507 is another Phase 3 study in the same general disease group, and it compares Zolbetuximab plus CAPOX with placebo plus CAPOX in first-line treatment.^[5]

NCT06901531 is a Phase 3 study that tests Zolbetuximab together with pembrolizumab and chemotherapy, compared with placebo plus pembrolizumab and chemotherapy, in adults with gastric cancer or GEJ adenocarcinoma.^[7]

NCT03505320 is a Phase 2 study in metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma, and it looks at Zolbetuximab as a single treatment and also in combination with chemotherapy and/or immunotherapy.^[1]

Trial in pancreatic cancer

NCT03816163 studies adults with metastatic pancreatic adenocarcinoma, which means pancreatic cancer that has spread to other parts of the body.^[6]

This Phase 2 trial is for people with CLDN18.2-positive disease and looks at Zolbetuximab with nab-paclitaxel and gemcitabine in the first-line setting, meaning it is used as an initial treatment.^[6]

The study includes a safety lead-in phase to confirm the recommended phase 2 dose (RP2D), which is the dose chosen for later testing based on early safety data.^[6]

Main endpoints used in the studies

The trials measure different endpoints, which are the main results the researchers want to study.^{[1][2][3][4][5][6][7]}

One study measures objective response rate (ORR), which is the percentage of patients whose tumors shrink or disappear on imaging or review.^[1]

Several studies measure overall survival (OS), which is the time from the trial start point until death from any cause.^[2][3][6][7]

Other studies measure progression-free survival (PFS), which is the time before the cancer gets worse or the patient dies.^[4][5]

The pancreatic trial also measures safety and tolerability using adverse events, laboratory tests, vital signs, ECGs, and ECOG performance status, which is a simple scale showing how well a person can carry out daily activities.^[6]

Who the trials are for

These studies mainly include adults with advanced disease, such as metastatic cancer or locally advanced unresectable cancer.^{[1][4][5][6][7]}

Many trials require CLDN18.2-positive tumors, which means the cancer has a marker that the study uses to select patients.^{[1][3][4][5][6]}

Some gastric and GEJ trials also require HER2-negative disease, so people with high HER2 levels are not the target group for those studies.^[4][5]

One trial is in second-line treatment, meaning the people had earlier treatment before joining the study, while other studies are in the first-line setting, which means the first treatment used for that cancer.^{[3][4][5][6][7]}

Study design and comparison groups

The trials compare Zolbetuximab with placebo or with standard treatment, so researchers can see whether adding Zolbetuximab changes the results.^[3][4][5][7]

Some studies test Zolbetuximab with chemotherapy such as mFOLFOX6, CAPOX, nab-paclitaxel, gemcitabine, or other regimens listed in the trial data.^{[1][4][5][6][7]}

One Phase 2 study also includes Zolbetuximab with chemotherapy and/or immunotherapy, which means treatment that helps the immune system fight cancer.^[1]

Trial summary table

Table of Contents

• Overview of the clinical trial program
• Trials in plaque psoriasis
• Trials in psoriatic arthritis
• Trials in ulcerative colitis and Crohn’s disease
• Trials in vitiligo and hidradenitis suppurativa
• Main endpoints and what they mean
• Who can join these studies

Overview of the clinical trial program

Clinical trials of Zasocitinib are studying several diseases, mainly moderate-to-severe plaque psoriasis and psoriatic arthritis, with additional studies in ulcerative colitis, Crohn’s disease, non-segmental vitiligo, and hidradenitis suppurativa.^{[1][2][3][4][5][6][7][8][9][10][11][12][13]}

Most of the studies are Phase 3 trials, while some are Phase 2 or Phase 2b trials.^{[1][2][3][4][5][6][7][8][9][10][11][12][13]}

These trials are designed to measure both efficacy and safety, and several also look at tolerability, long-term follow-up, or comparison with placebo or another treatment.^{[1][2][3][4][5][6][7][8][9][10][11][12][13]}

Trials in plaque psoriasis

Several studies are focused on moderate-to-severe plaque psoriasis, which is a long-term skin disease that causes thick, scaly plaques.^{[1][2][4][5][13]}

One Phase 3 study is an open-label, multicenter trial looking at the long-term safety, tolerability, and efficacy of Zasocitinib in people with moderate-to-severe plaque psoriasis.^[1]

Two completed Phase 3 studies compared Zasocitinib with placebo over 16 weeks and measured skin improvement using sPGA 0/1 response and PASI-75 at Week 16.^[2][5]

Another completed Phase 3 study compared Zasocitinib with deucravacitinib and measured PASI-100, which means complete skin clearance on the score used in the study.^[4]

A pediatric Phase 3 study includes adolescents and children with plaque psoriasis and has two parts: one part checks skin improvement at Week 16, and another part measures pharmacokinetics, which means how the body handles the study drug, in younger children.^[12]

Trials in psoriatic arthritis

Zasocitinib is also being studied in psoriatic arthritis, a disease that causes joint inflammation in people who may also have psoriasis.^[3][6][13]

Two Phase 3 studies are evaluating whether Zasocitinib improves joint symptoms in adults with active psoriatic arthritis, including people with or without prior biologic DMARD exposure, which means previous use of advanced immune-targeting medicines.^[3][6][13]

The main endpoint in these arthritis trials is ACR20 at Week 16, which means a 20% improvement in arthritis signs and symptoms.^[3][6]

One of these studies is a long-term extension trial that follows adults over time to check continued safety, tolerability, and efficacy.^[13]

Trials in ulcerative colitis and Crohn’s disease

Some studies are testing Zasocitinib in ulcerative colitis and Crohn’s disease, which are inflammatory bowel diseases that affect the digestive tract.^[5][8][9]

A Phase 2 study in moderately to severely active ulcerative colitis is measuring clinical remission at Week 12 using the modified Mayo score, stool frequency, rectal bleeding, and endoscopy findings.^[5]

A Phase 2b study in moderately to severely active Crohn’s disease is measuring endoscopic response at Week 12, based on improvement in the Simple Endoscopic Score for Crohn’s Disease.^[8]

A Phase 2 continuation study is following people with ulcerative colitis or Crohn’s disease who met response criteria at Week 52 in the parent trials, and it tracks long-term safety, lab changes, vital signs, and special safety events for up to 108 weeks.^[9]

Trials in vitiligo and hidradenitis suppurativa

Zasocitinib is also being studied in non-segmental vitiligo, a condition that causes patchy loss of skin color.^[10]

This Phase 2 study in adults measures the proportion of participants who achieve at least 75% improvement in F-VASI at Week 24, which is a score used to track facial skin color improvement.^[10]

Another Phase 2 study is testing Zasocitinib in moderate to severe hidradenitis suppurativa, a painful inflammatory skin condition with abscesses and nodules.^[11]

The main endpoint in that study is HiSCR75 at Week 16, which means at least a 75% drop in abscess and inflammatory nodule count without more abscesses or draining tunnels.^[11]

Main endpoints and what they mean

The trials use different endpoints, but most are designed to measure how much the disease improves after treatment with Zasocitinib.^{[1][2][3][4][5][8][10][11]}

• sPGA 0/1: a skin score showing clear or almost clear skin, with at least a 2-point improvement from the start of the study.^[2][5][12]

• PASI-75: at least 75% improvement in psoriasis severity from baseline.^[2][5][12]

• PASI-100: complete improvement in the psoriasis score used in the study.^[4]

• ACR20: a 20% improvement in arthritis symptoms and signs.^[3][6]

• Clinical remission: very low or absent disease activity in ulcerative colitis at the time measured in the study.^[5]

• Endoscopic response: improvement seen on a camera test inside the bowel.^[8]

• HiSCR75: major improvement in hidradenitis suppurativa with fewer abscesses and inflammatory nodules.^[11]

• PK or pharmacokinetics: how the body absorbs, moves, and removes the study drug.^[12]

Who can join these studies

The target groups vary by trial, but most studies include people with active, moderate to severe disease who still need treatment options.^{[1][2][3][5][8][10][11]}

Some trials are for adults only, such as the psoriatic arthritis, ulcerative colitis, Crohn’s disease, vitiligo, and hidradenitis suppurativa studies.^{[3][5][8][9][10][11][13]}

The pediatric psoriasis study includes adolescents aged 12 to less than 18 years, and it plans to include children aged 4 to less than 12 years in a later part of the protocol.^[12]

Several trials also compare Zasocitinib with placebo, which helps researchers see whether the study drug works better than no active treatment.^{[2][4][5][8][10][11]}

Table of contents

• Clinical trials overview
• Studies in liver cirrhosis
• Study in chronic kidney disease
• What researchers measure
• Who the trials include
• Trial design and comparators

Clinical trials overview

The trial data describe three interventional studies of Zibotentan, meaning the treatment is given to people and then compared with another group.^[1][2][3] Two studies are in liver disease, and one study is in kidney disease.^[1][2][3] The studies include Phase 2, Phase 2b, and Phase 3 research, so they range from earlier testing to a larger confirmatory trial.^[1][2][3]

Studies in liver cirrhosis

One completed Phase 2 study, called the ZEAL study, looked at people with liver cirrhosis and features of portal hypertension, which means high pressure in the blood vessels that go to the liver.^[1] This study compared Zibotentan and dapagliflozin in combination with placebo, and its main goal was to see the change in HVPG from baseline to Week 6.^[1] HVPG stands for hepatic venous pressure gradient, a test that helps show pressure in the liver blood flow system.^[1]

A second completed Phase 2b study, ZEAL-UNLOCK, looked at people with cirrhosis of the liver and focused on safety.^[2] The study examined Zibotentan and dapagliflozin, Zibotentan alone, and placebo groups, with attention to fluid retention, which means the body holding extra fluid and possibly causing weight gain or swelling.^[2] The main outcomes included body weight, total body water, body fat mass, blood pressure, and use of loop-diuretic equivalents over 6 weeks.^[2]

Study in chronic kidney disease

The Phase 3 study, NCT06087835, is authorised and is testing Zibotentan combined with dapagliflozin in people with chronic kidney disease and high proteinuria, which means too much protein in the urine.^[3] The study compares the fixed-dose combination with dapagliflozin alone and includes a large enrollment of 1833 people.^[3] Its main outcome is the change in eGFR from baseline to Month 24, which shows how well the kidneys are filtering blood.^[3]

What researchers measure

In the liver cirrhosis studies, researchers focus on pressure in the liver circulation and on signs of fluid buildup.^[1][2] These measures include HVPG, body weight, total body water, and changes in diuretic use, which are medicines that help the body remove extra fluid.^[1][2]

In the kidney study, the main measure is eGFR over 24 months, because this helps show whether kidney function declines more slowly.^[3] The study summary says the goal is to see whether the combination is superior to dapagliflozin alone in slowing kidney decline.^[3]

Who the trials include

The study populations are adults with liver cirrhosis, adults with liver cirrhosis and portal hypertension, or adults with chronic kidney disease and high proteinuria.^[1][2][3] The trial data do not give full eligibility rules, so exact entry criteria are not listed here.^[1][2][3]

Trial design and comparators

All three studies are interventional trials, so they compare one treatment approach with another approach or with placebo.^[1][2][3] In the liver studies, the trial data mention Zibotentan, dapagliflozin, placebo, and Zibotentan monotherapy in different groups.^[1][2] In the kidney study, the comparison is between the Zibotentan plus dapagliflozin combination and dapagliflozin alone.^[3]