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A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease
EU CTIS ID: 2024-515027-11-00
What this study is testing
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV 48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult patients with IBD (moderate to severe UC or CD) as assessed by maintenance of clinical remission (UC) and endoscopic response (CD) at end of maintenance period (EOM).
- 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
- 1.Maintenance Period: Adults of male and female sex (without restrictions based on gender) who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study. OLE Period: Adults of male and female sex (without restrictions based on gender) who have clinical response and/or clinical remission at week 44 of the maintenance period of this study.
- 2. Re-induction Period: Adults of male and female sex (without restrictions based on gender) who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study
You likely can't join if
- 1.Patients who discontinued the DRF study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons).
- 2. The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician.
- 3. Patient anticipates requiring major surgery during this study.
- 4. The patient is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Israel
- Ukraine
- United States
- United Kingdom
- Japan
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; Israel; Ukraine; United States; United Kingdom; Japan. 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.