Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05499130
The ClinicalTrials.gov registry entry for NCT05499130 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 71 other Crohn Disease trials with a reported enrollment target (44% 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 Placebo is the first listed.
NCT05499130 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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
Similar trials for Crohn Disease
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.
-
Standardized Microbiota Transplant Therapy in Crohn's Disease
RECRUITING · Phase 2
-
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
RECRUITING · Phase 2
-
Precise Infliximab Exposure and Pharmacodynamic Control
RECRUITING · Phase 2
-
Autologous Stem Cell Transplant for Crohn's Disease
RECRUITING · Phase 2
-
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
ACTIVE NOT RECRUITING · Phase 2
-
A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease
ACTIVE NOT RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.