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NCT05270668 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study of Interstitial Lung Disease and Diffuse Cutaneous Systemic Sclerosis, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Active
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT05270668: Active Phase 2 study of Interstitial Lung Disease and Diffuse Cutaneous Systemic Sclerosis, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT05270668 is a Phase 2 study of Interstitial Lung Disease and Diffuse Cutaneous Systemic Sclerosis that is active but no longer recruiting, run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 154 participants, below the 562-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05270668, a Phase 2 study of Interstitial Lung Disease and Diffuse Cutaneous Systemic Sclerosis, is active but no longer recruiting, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Primary Outcome
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an AE will be reported.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tulisokibart
- DIAGNOSTIC_TEST Companion diagnostic ( CDx)
Study Locations (20)
California
- Pacific Arthritis Care Center ( Site 4008) - Los Angeles
- Cedars Sinai Medical Center ( Site 4010) - Los Angeles
- UCLA School of Medicine ( Site 4006) - Los Angeles
- Stanford Health Care ( Site 4009) - Palo Alto
Massachusetts
- Massachusetts General Hospital ( Site 4003) - Boston
- Boston University School of Medicine ( Site 4021) - Boston
Ohio
- Cleveland Clinic Foundation ( Site 4019) - Cleveland
- University of Toledo Medical Center ( Site 4002) - Toledo
Arizona
- Mayo Clinic - Scottsdale ( Site 4014) - Phoenix
Colorado
- National Jewish Health Medical Center ( Site 4015) - Denver
Connecticut
- Yale University ( Site 4017) - New Haven
District of Columbia
- MedStar Georgetown University Hospital ( Site 4005) - Washington D.C.
Maryland
- Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018) - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 2 |
Sponsor
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)6 total trials
What the registry record for NCT05270668 still lists
NCT05270668 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 562-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Interstitial Lung Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05270668 names 20 study sites across 15 states, led by California, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT05270668 about?
NCT05270668 is a clinical study titled "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)". The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
What is the current status of trial NCT05270668?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2022-03-29. Estimated completion is 2029-07-31.
What conditions does trial NCT05270668 study?
This clinical trial studies the following conditions: Interstitial Lung Disease, Diffuse Cutaneous Systemic Sclerosis.
What interventions are being tested in trial NCT05270668?
The interventions under investigation include: Placebo (DRUG), Tulisokibart (DRUG), Companion diagnostic ( CDx) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05270668?
This trial is sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05270668 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Interstitial Lung 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 NCT05270668's enrollment target sits among peer trials
154 17th of 36 higher than 20 of 36 other Interstitial Lung Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Interstitial Lung 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.
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