TEV-48574 for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

+124 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a new drug called TEV-48574, given as a shot periodically, in adults with inflammatory bowel disease. It aims to see how well the drug works, how safe it is, and how the body reacts to it.

Eligibility Criteria

This trial is for adults with moderate to severe Ulcerative Colitis or Crohn's Disease who showed improvement in a previous 14-week study. Women must not be pregnant, should test negative for pregnancy, and use effective birth control. Men with partners of childbearing potential must use condoms.

Inclusion Criteria

Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study

I showed improvement or remission at week 14 of my previous study.

Exclusion Criteria

Participant 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 Any woman becoming pregnant during the study will be withdrawn from the study

Participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician

I expect to need major surgery during the study.

+1 more

Participant Groups

The trial tests two different long-term dosing regimens of TEV-48574, administered every four weeks by injection under the skin. It aims to determine the effectiveness, safety, tolerability, and immune response over up to 66 weeks per participant.

4Treatment groups

Experimental Treatment

Group I: TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)Experimental Treatment1 Intervention

Administered by subcutaneous infusion for participants with UC

Group II: TEV-48574 Dose Regimen B for Crohn's Disease (CD)Experimental Treatment1 Intervention

Administered by subcutaneous infusion for participants with CD

Group III: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)Experimental Treatment1 Intervention

Administered by subcutaneous infusion for participants with UC

Group IV: TEV-48574 Dose Regimen A for Crohn's Disease (CD)Experimental Treatment1 Intervention

Administered by subcutaneous infusion for participants with CD