In short
Eclitasertib, also known as SAR443122, is an investigational drug currently being studied in clinical trials for the treatment of moderate to severe ulcerative colitis. This article explores the ongoing research, potential benefits, and important information about Eclitasertib in clinical trials for patients with this inflammatory bowel disease.
At a glance
- Drug Name
- Eclitasertib (SAR443122)
- Condition Studied
- Moderate to severe ulcerative colitis
- Study Type
- Randomized, double-blind, placebo-controlled, dose-finding study
- Primary Objective
- Assess efficacy of different doses in induction treatment period
- Key Secondary Objectives
- Evaluate endoscopic improvement, clinical remission, histologic improvement, quality of life changes
- Treatment Duration
- 52 weeks
- Main Eligibility Criteria
- Adults with active UC for ≥3 months, inadequate response to previous treatments
- Primary Endpoint
- Proportion of participants achieving clinical remission at Week 12
- Safety Monitoring
- Assessment of Treatment Emergent Adverse Events (TEAEs)
What is ECLITASERTIB?
ECLITASERTIB, also known by its sponsor product code SAR443122, is a new medication being studied for the treatment of moderate to severe ulcerative colitis. It is currently undergoing clinical trials to assess its effectiveness and safety in adult patients.
Medical Condition: Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum. Symptoms can include diarrhea, abdominal pain, and rectal bleeding. The condition can significantly impact a person's quality of life.
How ECLITASERTIB Works
ECLITASERTIB is a RIPK1 kinase inhibitor. RIPK1 (Receptor-interacting serine/threonine-protein kinase 1) is an enzyme involved in inflammatory processes. By inhibiting this enzyme, ECLITASERTIB may help reduce inflammation in the colon and alleviate symptoms of ulcerative colitis.
Clinical Trial Details
The ongoing clinical trial for ECLITASERTIB is a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either ECLITASERTIB or a placebo, and neither the participants nor the researchers know who is receiving which treatment. The main goal of the study is to assess the efficacy of different doses of ECLITASERTIB in treating moderate to severe ulcerative colitis during an induction treatment period.
Potential Benefits of ECLITASERTIB
The clinical trial aims to evaluate several potential benefits of ECLITASERTIB, including:
- Clinical remission (reduction or disappearance of symptoms)
- Endoscopic improvement (healing of the colon lining as seen during an endoscopy)
- Histologic improvement (improvement in the microscopic appearance of colon tissue)
- Improved quality of life for patients with ulcerative colitis
- Reduction in patient-reported signs and symptoms of ulcerative colitis
These outcomes will be measured using various tools and assessments throughout the study.
Who Can Participate in the ECLITASERTIB Trial?
The trial is open to adult patients with moderate to severe ulcerative colitis. Some key eligibility criteria include:
- Having active ulcerative colitis for at least 3 months before screening
- Having a minimum disease extent of 15 centimeters from the anal verge
- Being inadequate responders, non-responders, or intolerant to at least one approved treatment for ulcerative colitis
- Not having certain other medical conditions that could interfere with the study or pose additional risks
There are also specific criteria regarding current and previous medications. It's important to note that eligibility is determined by the study doctors and there are additional inclusion and exclusion criteria.
How is ECLITASERTIB Administered?
ECLITASERTIB is administered orally in the form of hard capsules. The study is testing different doses of the medication, with a maximum daily dose of up to 600 mg. The treatment period in the study lasts for 52 weeks.
Safety Considerations
As with any clinical trial, the safety of participants is a top priority. The study will closely monitor for any side effects or adverse events. Some specific safety considerations include:
- Participants with certain medical conditions, such as active infections, uncontrolled diabetes, or a history of certain cancers, are excluded from the study
- The study excludes individuals who have received live vaccines within 3 months prior to the start of the trial
- Participants will be monitored for any changes in their health status throughout the study
It's important to note that as ECLITASERTIB is still in the clinical trial phase, not all potential side effects may be known. Participants in the trial will be closely monitored and should report any unusual symptoms to the study doctors.