A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
Public ClinicalTrials.gov record NCT04996797. 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 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Study identification
- NCT ID
- NCT04996797
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Industry
- Enrollment
- 178 participants
Conditions and interventions
Conditions
Interventions
- Tulisokibart Drug
- Companion Diagnostic (CDx) Testing Device
- Placebo Other
Drug · Device · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jul 14, 2021 (Actual)
- Primary completion
- Jun 6, 2023 (Actual)
- Completion
- Jul 14, 2025 (Actual)
- Last update posted
- Sep 1, 2026
2021 – 2025
United States locations
- U.S. sites
- 29
- U.S. states
- 17
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Prometheus Biosciences Selected Center | Mobile | Alabama | 36608 | — |
| Prometheus Biosciences Selected Site | Phoenix | Arizona | 85006 | — |
| Prometheus Biosciences Selected Site | Sun City | Arizona | 85351 | — |
| Prometheus Biosciences Selected Site | Los Angeles | California | 90045 | — |
| Prometheus Biosciences Selected Site | Los Angeles | California | 90048 | — |
| Prometheus Biosciences Selected Site | San Diego | California | 92037 | — |
| Prometheus Biosciences Selected Site | Bristol | Connecticut | 06010 | — |
| Prometheus Biosciences Selected Site | Atlanta | Georgia | 30010 | — |
| Prometheus Biosciences Selected Site | Arlington Heights | Illinois | 60005 | — |
| Prometheus Biosciences Selected Site | Glenview | Illinois | 60026 | — |
| Prometheus Biosciences Selected Site | Gurnee | Illinois | 60031 | — |
| Prometheus Biosciences Selected Site | Kansas City | Kansas | 66160 | — |
| Prometheus Biosciences Selected Site | Liberty | Kansas | 64098 | — |
| Prometheus Biosciences Selected Site | Baton Rouge | Louisiana | 70809 | — |
| Prometheus Biosciences Selected Site | Chevy Chase | Maryland | 20815 | — |
| Prometheus Biosciences Selected Site | Chesterfield | Michigan | 48047 | — |
| Prometheus Biosciences Selected Site | Lebanon | New Hampshire | 03756 | — |
| Prometheus Biosciences Selected Site | New York | New York | 10029 | — |
| Prometheus Biosciences Selected Site | New York | New York | 10065 | — |
| Prometheus Biosciences Selected Site | Dublin | Ohio | 43016 | — |
| Prometheus Biosciences Selected Site | Germantown | Tennessee | 38138 | — |
| Prometheus Biosciences Selected Site | Bedford | Texas | 76022 | — |
| Prometheus Biosciences Selected Site | Lubbock | Texas | 79424 | — |
| Prometheus Biosciences Selected Site | Mansfield | Texas | 76063 | — |
| Prometheus Biosciences Selected Site | San Antonio | Texas | 78229 | — |
| Prometheus Biosciences Selected Site | Southlake | Texas | 76092 | — |
| Prometheus Biosciences Selected Site | Tyler | Texas | 75702 | — |
| Prometheus Biosciences Selected Site | Charlottesville | Virginia | 22903 | — |
| Prometheus Biosciences Selected Site | Tacoma | Washington | 98405 | — |
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 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04996797, 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 Sep 1, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04996797 live on ClinicalTrials.gov.