A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Public ClinicalTrials.gov record NCT05668013. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Treatment Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05668013
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 247 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 10, 2023
- Primary completion
- Jan 4, 2026
- Completion
- Mar 7, 2031
- Last update posted
- Aug 6, 2026
2023 – 2031
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 15556 | San Diego | California | 92103 | — |
| Teva Investigational Site 15357 | Kissimmee | Florida | 34741 | — |
| Teva Investigational Site 15375 | Orlando | Florida | 32803 | — |
| Teva Investigational Site 15359 | Pinellas Park | Florida | 33781 | — |
| Teva Investigational Site 15567 | Gurnee | Illinois | 60031 | — |
| Teva Investigational Site 15574 | New Albany | Indiana | 47150 | — |
| Teva Investigational Site 15367 | Kansas City | Kansas | 66160 | — |
| Teva Investigational Site 15575 | Louisville | Kentucky | 40218 | — |
| Teva Investigational Site 15358 | Liberty | Missouri | 64068 | — |
| Teva Investigational Site 15373 | St Louis | Missouri | 63110 | — |
| Teva Investigational Site 15369 | Las Vegas | Nevada | 89128. | — |
| Teva Investigational Site 15750 | Beavercreek | Ohio | 45440 | — |
| Teva Investigational Site 15559 | Harlingen | Texas | 78550 | — |
| Teva Investigational Site 15366 | Katy | Texas | 77494 | — |
| Teva Investigational Site 15374 | San Antonio | Texas | 78229 | — |
| Teva Investigational Site 15565 | Southlake | Texas | 76092 | — |
| Teva Investigational Site 15361 | Tyler | Texas | 75701 | — |
| Teva Investigational Site 15364 | Salt Lake City | Utah | 84124 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05668013, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05668013 live on ClinicalTrials.gov.