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Eclitasertib

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.

Table of Contents

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[1].

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[1].

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[1].

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[1].

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[1].

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[1].

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[1].

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[1].

Aspect Details
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)

FAQ

  • What is Eclitasertib and how does it work? Eclitasertib (SAR443122) is an investigational drug that belongs to a class of medications called RIPK1 inhibitors. It is being studied for its potential to reduce inflammation and improve symptoms in people with moderate to severe ulcerative colitis. The exact mechanism of action is still being researched, but it is believed to work by targeting specific inflammatory pathways in the body.
  • Who is eligible to participate in the Eclitasertib clinical trial? The trial is open to adults with moderate to severe ulcerative colitis who have had the condition for at least 3 months. Participants must have tried other treatments without success or experienced side effects. The disease must extend at least 15 centimeters from the anal verge. There are specific criteria for medication use and stability of doses before and during the screening period.
  • What are the main goals of the Eclitasertib clinical trial? The primary goal is to assess the effectiveness of different doses of Eclitasertib in inducing clinical remission in patients with moderate to severe ulcerative colitis. Secondary objectives include evaluating its effects on endoscopic improvement, clinical response, histologic improvement, and quality of life. The trial also aims to assess the safety and tolerability of Eclitasertib over 52 weeks.
  • How is the effectiveness of Eclitasertib measured in the trial? The main measure of effectiveness is the proportion of participants who achieve clinical remission at Week 12, as determined by a modified Mayo Score. This score takes into account factors such as stool frequency, rectal bleeding, and endoscopy findings. Other measures include endoscopic improvement, histological improvement, and changes in patient-reported outcomes and quality of life scores.
  • What are the potential risks or side effects of participating in the Eclitasertib trial? As with any clinical trial, there may be risks and side effects associated with Eclitasertib. The trial is designed to monitor for Treatment Emergent Adverse Events (TEAEs) during both the induction and maintenance treatment periods. Specific risks are not detailed in the provided information, but participants will be closely monitored throughout the study. It's important to discuss potential risks with the study doctor before participating.

Ongoing Clinical Trials on Eclitasertib

  • Study on the Effects of Eclitasertib in Adults with Moderate to Severe Ulcerative Colitis

    Not recruiting

    2 1
    Investigated drugs:
    Bulgaria Czechia France Germany Hungary Italy +5

Glossary

  • Ulcerative Colitis (UC): A chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum.
  • RIPK1 inhibitor: A type of drug that targets and blocks the activity of the RIPK1 enzyme, which is involved in inflammatory processes in the body.
  • Clinical remission: A state where the signs and symptoms of the disease are significantly reduced or absent, often measured using specific scoring systems like the Mayo Score.
  • Endoscopic improvement: A reduction in the visible signs of inflammation and damage to the intestinal lining as observed through an endoscope (a thin, flexible tube with a camera).
  • Histologic improvement: Positive changes in the microscopic appearance of tissue samples taken from the intestine, indicating a reduction in inflammation at the cellular level.
  • Modified Mayo Score (mMS): A scoring system used to assess the severity of ulcerative colitis, which includes measures of stool frequency, rectal bleeding, and endoscopy findings, but excludes the physician's global assessment.
  • Induction treatment: The initial phase of treatment aimed at rapidly reducing inflammation and improving symptoms.
  • Maintenance treatment: The long-term phase of treatment aimed at keeping the disease in remission and preventing flare-ups.
  • Treatment Emergent Adverse Events (TEAEs): Any unfavorable and unintended sign, symptom, or disease that appears or worsens after starting the study treatment.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-eclitasertib-in-adults-with-moderate-to-severe-ulcerative-colitis/