Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Crohn Disease and Colitis, Ulcerative, sponsored by Teva Branded Pharmaceutical Products R&D.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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"
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 |
What the registry record for NCT05668013 still lists
NCT05668013 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, above the 202-participant average among 71 other Crohn Disease trials with a reported enrollment target (22% higher).
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 names 20 study sites across 12 states, led by 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.
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.
Where NCT05668013's enrollment target sits among peer trials
247 16th of 71 higher than 56 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
-
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 Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04269902 · 247 participants · Phase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
- NCT04989803 · 247 participants · Phase 1
Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma
- NCT05521399 · 247 participants
Heart Transplantation - Renewal
- NCT05556824 · 247 participants · Phase 2
Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI