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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) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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)

NCT05270668•Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
•Has diffuse cutaneous scleroderma
•Has systemic sclerosis related interstitial lung disease confirmed by HRCT
•FVC ≥ 45% of predicted normal
•Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal
•If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) OR azathioprine, and corticosteroids
•Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptable contraceptive method or sexually abstinent
•Able to provide written informed consent and understand and comply with the requirements of the study

Exclusion Criteria

•Has an airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension
•Has current clinical diagnosis of another inflammatory connective tissue disease
•Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection
•Is a current smoker or smoking within 6 months of screening
•Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study

Locations (95)

Mayo Clinic - Scottsdale ( Site 4014)

Phoenix, Arizona, United States

Pacific Arthritis Care Center ( Site 4008)

Los Angeles, California, United States

Cedars Sinai Medical Center ( Site 4010)

Los Angeles, California, United States

UCLA School of Medicine ( Site 4006)

Los Angeles, California, United States

Stanford Health Care ( Site 4009)

Palo Alto, California, United States

National Jewish Health Medical Center ( Site 4015)

Denver, Colorado, United States

Yale University ( Site 4017)

New Haven, Connecticut, United States

MedStar Georgetown University Hospital ( Site 4005)

Washington D.C., District of Columbia, United States

Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 4003)

Boston, Massachusetts, United States

Key Dates

Start Date

March 29, 2022

Primary Completion Date

April 30, 2026

Completion Date

July 31, 2029

Last Updated

October 20, 2025

Enrollment

154

ACTUAL participants

Conditions

Diffuse Cutaneous Systemic SclerosisInterstitial Lung Disease

Interventions

Tulisokibart

DRUG

Companion diagnostic ( CDx)

DIAGNOSTIC_TEST

Placebo

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE1

A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease

NCT06992661

Interstitial Lung Disease (ILD)Healthy Volunteers

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease

Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Functional MRI for Monitoring Progression and Assessing Trends in ILD

Treatable Traits in Interstitial Lung Disease