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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 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.

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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.

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

FieldValue
Enrollment Target 154 participants
Start Date 2022-03-29
Est. Completion 2029-07-31
Phase Phase 2

What the Registry Record Tells You About NCT05270668

The ClinicalTrials.gov registry entry for NCT05270668 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 562-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (73% lower). The listed sponsor is Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.