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A study to investigate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn’s disease or ulcerative colitis
EU CTIS ID: 2025-522511-42-00
What this study is testing
To assess the long-term safety and tolerability of different doses of balinatunfib in participants with Crohn’s disease (CD) or ulcerative colitis (UC)
- Therapeutic exploratory (Phase II)
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
- Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively: · Participants with CD 1. who complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study; 2. who complete open label treatment and achieve the appropriate outcomes at Week 52 of SPECIFI-CD (DRI18212) study. OR · Participants with UC 1. who complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study; 2. who complete open label treatment and achieve the appropriate outcomes at Week 52 of the SPECIFI-UC (DRI17822) study.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.
You likely can't join if
- Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol.
- Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol.
- Participants who developed a new medical condition or a change in status of an established medical condition which (per Investigator’s medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation.
- Participants who permanently discontinued IMP during the parent study or temporarily discontinued IMP for more than 14 consecutive calendar days by the time of Day 1 of LTS19689.
- Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to balinatunfib, which in the opinion of the Investigator could indicate that continued treatment with balinatunfib may present an unreasonable risk for the participant.
- Participants who in the parent study had documented nonadherence to IMP or to standard therapies for CD or UC, or who used a prohibited medication concomitant with IMP or during a temporary IMP discontinuation period.
The study team makes the final eligibility decision.
Where it's taking place
- Mauritius
- Korea, Republic of
- United States
- Australia
- South Africa
- Georgia
- Argentina
- Turkey
- India
- Chile
- Japan
- Brazil
- Canada
- China
- Egypt
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mauritius; Korea, Republic of; United States; Australia; South Africa; Georgia and 9 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.