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ABX464 for Ulcerative Colitis
Study Summary
This trial studies how well a new drug works to treat ulcerative colitis in people who aren't responding to other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 32 Patients • NCT03093259Trial Design
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Who is running the clinical trial?
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- I am using or willing to use effective birth control methods.My condition involves active disease with specific scores for bleeding and endoscopy.I have tried 5-ASA therapy for my condition without success.I have hepatitis B.I have not responded well to treatments like steroids, immunosuppressants, or biologics.I have signed the consent form and, if under-aged, have met national consent requirements.I am at least 16 years old, weigh over 40 kg, and have fully developed physically.
- Group 1: Placebo
- Group 2: ABX464 50mg
- Group 3: ABX464 25mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants have been enrolled in this experiment?
"Affirmative. By consulting clinicaltrials.gov, it is apparent that this trial began on December 21st 2022 and was recently amended on January 31st 2023. The research requires 612 candidates from two separate locations to be enrolled in the study."
Are any additional participants needed for this research project?
"The clinical trial database indicates that this research is currently recruiting participants. The project was initially publicized on December 21st 2022 and the last update occurred on January 31st 2023."
Has the US Food and Drug Administration approved ABX464 of 50mg dosage?
"As a Phase 3 trial, ABX464 50mg has sufficient clinical evidence to be deemed safe with an assigned score of 3."
What is the primary aim of this medical experiment?
"Abivax S.A., the trial sponsor, has declared that assessing clinical remission over an 8 week period will be their primary objective for this study. In addition to evaluating the efficacy of ABX464 versus placebo, secondary outcomes such as endoscopic improvement, clinical response per MMS and symptomatic remission at week 8 are being measured."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Most responsive sites:
- Tandem Clinical Research - Houma, LA: < 48 hours
Average response time
- < 2 Days
Typically responds via
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