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)

NCT05270668 · tracked via the Priya Life Science USA tracker

Sponsor

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

Phase

Phase 2

Started

2022-03-29

Last updated

2026-05-18

Condition(s) studied

Diffuse Cutaneous Systemic SclerosisInterstitial Lung Disease

Investigational drug(s) / intervention(s)

TulisokibartCompanion diagnostic ( CDx)Placebo

Tulisokibart: Tulisokibart administered at timepoints as directed by the protocol

Companion diagnostic ( CDx): CDx+ or CDx-

Placebo: Placebo

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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 * Meets the protocol criteria for important laboratory exclusion criteria

Primary outcome measure(s)

Number of Participants who Experience an Adverse Event (AE) — Up to Week 50
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.
Number of Participants who Experience a Serious Adverse Event (SAE) — Up to Week 50
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 SAE will be reported.
Number of Participants who Discontinue due to an AE — Up to Week 50
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 discontinue due to an AE will be reported.
Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50 — Baseline and up to Week 50
FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible.

Trial sites (95)

Facility	City	Region
Mayo Clinic - Scottsdale ( Site 4014)	Phoenix	Arizona
Pacific Arthritis Care Center ( Site 4008)	Los Angeles	California
Cedars Sinai Medical Center ( Site 4010)	Los Angeles	California
UCLA School of Medicine ( Site 4006)	Los Angeles	California
Stanford Health Care ( Site 4009)	Palo Alto	California
National Jewish Health Medical Center ( Site 4015)	Denver	Colorado
Yale University ( Site 4017)	New Haven	Connecticut
MedStar Georgetown University Hospital ( Site 4005)	Washington D.C.	District of Columbia
Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)	Baltimore	Maryland
Massachusetts General Hospital ( Site 4003)	Boston	Massachusetts
Boston University School of Medicine ( Site 4021)	Boston	Massachusetts
University of Michigan Hospital ( Site 4001)	Ann Arbor	Michigan
Rutgers Robert Wood Johnson Medical School ( Site 4013)	New Brunswick	New Jersey
Hospital For Special Surgery ( Site 4020)	New York	New York
Cleveland Clinic Foundation ( Site 4019)	Cleveland	Ohio
University of Toledo Medical Center ( Site 4002)	Toledo	Ohio
University of Pittsburgh Medical Center ( Site 4016)	Pittsburgh	Pennsylvania
Medical University of South Carolina - PPDS ( Site 4004)	Charleston	South Carolina
UT Physicians Rheumatology ( Site 4007)	Houston	Texas
Froedtert and Medical College of Wisconsin ( Site 4012)	Milwaukee	Wisconsin
Consultorios Médicos Dr. Doreski ( Site 4800)	CABA	Buenos Aires
Clínica Privada Independencia ( Site 4802)	Munro	Buenos Aires
Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)	Río Cuarto	Córdoba Province
Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)	Rosario	Santa Fe Province
Royal Adelaide Hospital ( Site 4050)	Adelaide	South Australia
St Vincents Hospital Melbourne ( Site 4051)	Melbourne	Victoria
UZ Gent ( Site 4401)	Ghent	Oost-Vlaanderen
UZ Leuven ( Site 4402)	Leuven	Vlaams-Brabant
CHU de Liege ( Site 4400)	Liège	Wallonne, Region
University Of Alberta Hospital ( Site 4702)	Edmonton	Alberta
St. Joseph's Health Care London ( Site 4701)	London	Ontario
Mount Sinai Hospital [Toronto, Canada] ( Site 4700)	Toronto	Ontario
Centro de especialidades médicas Vanguardia ( Site 4850)	Temuco	Araucania
BIOCINETIC Ltda ( Site 4854)	Santiago	Region M. de Santiago
Centro de Investigacion Clinica UC CICUC ( Site 4855)	Santiago	Region M. de Santiago
Centro Internacional de Estudios Clinicos CIEC ( Site 4851)	Santiago	Region M. de Santiago
Clinica Dermacross ( Site 4853)	Vitacura	Region M. de Santiago
ONCOCENTRO APYS ( Site 4852)	Viña del Mar	Valparaiso
CHU de Bordeaux. Hopital Pellegrin ( Site 4202)	Bordeaux	Nord
Hôpital Claude Huriez ( Site 4200)	Lille	Nord

+ 55 more sites — see the full list on the official registry below.

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A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05270668 on ClinicalTrials.gov ↗ ← All trials in the USA