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ABTECT-Maintenance – ABX464 Treatment Evaluation for ulcerative Colitis Therapy
EU CTIS ID: 2022-500537-84-00
What this study is testing
To evaluate the efficacy of ABX464 versus placebo on clinical remission.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients’ clinical response status must be available.
- Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
- Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
- Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in the protocol.
- Subjects must be able and willing to comply with study visits and procedures as per protocol.
- Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.
You likely can't join if
- Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).
- Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except ulcerative colitis) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
- Subjects who plan to participate in other investigational studies during the maintenance study.
- Male or female planning a pregnancy within the coming 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- India
- United States
- Korea, Republic of
- Canada
- United Kingdom
- Japan
- Israel
- Taiwan
- China
- Brazil
- Turkey
- Argentina
- Mexico
- Australia
- New Zealand
- Bosnia and Herzegovina
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; India; United States; Korea, Republic of; Canada; United Kingdom and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.