A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

TEV-48574 Dose Regimen A: Subcutaneous (sc) administration using a commercial sc infusion system

TEV-48574 Dose Regiment B: Subcutaneous (sc) administration using a commercial sc infusion system

Study summary

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 participants with inflammatory bowel disease (IBD).

Secondary objectives of the study are to:

* evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
* evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
* evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD

The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.

Eligibility

Primary outcome measure(s)

• Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score — Week 44
  Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by: * stool frequency subscore of 0 or 1, * rectal bleeding subscore of 0, and * endoscopic subscore of 0 or 1, where a score of 1 does not include "friability"
• Number of participants with moderate to severe Crohn's disease (CD) who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease — Week 44
  Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD

Trial sites (93)

+ 53 more sites — see the full list on the official registry below.

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