Trials / Active Not Recruiting
Active Not RecruitingNCT05270668
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tulisokibart | Tulisokibart administered at timepoints as directed by the protocol |
| DIAGNOSTIC_TEST | Companion diagnostic ( CDx) | CDx+ or CDx- |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2022-03-29
- Primary completion
- 2026-04-30
- Completion
- 2029-07-31
- First posted
- 2022-03-08
- Last updated
- 2025-10-20
Locations
95 sites across 20 countries: United States, Argentina, Australia, Belgium, Canada, Chile, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Peru, Poland, Spain, Switzerland, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05270668. Inclusion in this directory is not an endorsement.