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NCT05668013 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
A Phase 2 study of Crohn Disease and Colitis, Ulcerative, sponsored by Teva Branded Pharmaceutical Products R&D.
- Active
- Registry status
- Phase 2
- Development phase
- 247
- Enrollment target
- 20
- Study locations
NCT05668013 is a Phase 2 study of Crohn Disease and Colitis, Ulcerative that is active but no longer recruiting, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 247 participants, above the 202-participant average among 71 other Crohn Disease trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT05668013, a Phase 2 study of Crohn Disease and Colitis, Ulcerative, is active but no longer recruiting, sponsored by Teva Branded Pharmaceutical Products R&D.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 247 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG TEV-48574 Dose Regimen A
- DRUG TEV-48574 Dose Regiment B
Study Locations (20)
Texas
- Teva Investigational Site 15559 - Harlingen
- Teva Investigational Site 15366 - Katy
- Teva Investigational Site 15374 - San Antonio
- Teva Investigational Site 15565 - Southlake
- Teva Investigational Site 15361 - Tyler
Florida
- Teva Investigational Site 15357 - Kissimmee
- Teva Investigational Site 15375 - Orlando
- Teva Investigational Site 15359 - Pinellas Park
Missouri
- Teva Investigational Site 15358 - Liberty
- Teva Investigational Site 15373 - St Louis
Other
- Teva Investigational Site 33056 - Vienna
- Teva Investigational Site 59243 - Gorna Oryahovitsa
California
- Teva Investigational Site 15556 - San Diego
Illinois
- Teva Investigational Site 15567 - Gurnee
Indiana
- Teva Investigational Site 15574 - New Albany
Kansas
- Teva Investigational Site 15367 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2023-01-11 |
| Est. Completion | 2031-03-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05668013
The ClinicalTrials.gov registry entry for NCT05668013 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 202-participant average among 71 other Crohn Disease trials with a reported enrollment target (22% higher). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which TEV-48574 Dose Regimen A is the first listed.
NCT05668013 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT05668013 about?
NCT05668013 is a clinical study titled "A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease". 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 ...
What is the current status of trial NCT05668013?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2023-01-11. Estimated completion is 2031-03-08.
What conditions does trial NCT05668013 study?
This clinical trial studies the following conditions: Crohn Disease, Colitis, Ulcerative.
What interventions are being tested in trial NCT05668013?
The interventions under investigation include: TEV-48574 Dose Regimen A (DRUG), TEV-48574 Dose Regiment B (DRUG).
Who is sponsoring clinical trial NCT05668013?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05668013 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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