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NCT05499130 · ClinicalTrials.gov registry record · Phase 2
A Study to Test the 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.
- Completed
- Registry status
- Phase 2
- Development phase
- 290
- Enrollment target
- 20
- Study locations
NCT05499130: Completed Phase 2 study of Crohn Disease and Colitis, Ulcerative, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT05499130 is a Phase 2 study of Crohn Disease and Colitis, Ulcerative that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 290 participants, above the 201-participant average among 71 other Crohn Disease trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05499130, a Phase 2 study of Crohn Disease and Colitis, Ulcerative, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 290 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: * To evaluate the efficacy of 2 different doses of TEV-48574 as assessed by multiple standard measures * To evaluate the safety and tolerability of 2 different doses of TEV-48574 * To evaluate the immunogenicity of 2 different dioses of TEV-48574 The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.
Primary Outcome
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequ
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TEV-48574
Study Locations (20)
Florida
- Teva Investigational Site 15357 - Kissimmee
- Teva Investigational Site 15563 - Miami
- Teva Investigational Site 15365 - Miami
- Teva Investigational Site 15748 - Miami
- Teva Investigational Site 15375 - Orlando
- Teva Investigational Site 15359 - Pinellas Park
California
- Teva Investigational Site 15556 - San Diego
- Teva Investigational Site 15747 - San Diego
Illinois
- Teva Investigational Site 15566 - Glenview
- Teva Investigational Site 15567 - Gurnee
Kentucky
- Teva Investigational Site 15368 - Louisville
- Teva Investigational Site 15575 - Louisville
Missouri
- Teva Investigational Site 15358 - Liberty
- Teva Investigational Site 15373 - St Louis
Arizona
- Teva Investigational Site 15568 - Sun City
Indiana
- Teva Investigational Site 15574 - New Albany
Iowa
- Teva Investigational Site 15362 - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2024-11-12 |
| Phase | Phase 2 |
What the finished NCT05499130 record still lists
NCT05499130 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, above the 201-participant average among 71 other Crohn Disease trials with a reported enrollment target (44% higher).
The record links to 2 conditions, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05499130 names 20 study sites across 11 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05499130 about?
NCT05499130 is a clinical study titled "A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease". The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: * To evaluate the e...
What is the current status of trial NCT05499130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 290 participants. The study started on 2022-09-30. Estimated completion is 2024-11-12.
What conditions does trial NCT05499130 study?
This clinical trial studies the following conditions: Crohn Disease, Colitis, Ulcerative.
What interventions are being tested in trial NCT05499130?
The interventions under investigation include: Placebo (DRUG), TEV-48574 (DRUG).
Who is sponsoring clinical trial NCT05499130?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05499130 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05499130's enrollment target sits among peer trials
290 14th of 71 higher than 58 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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