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)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
In brief
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Key facts
- Study ID
- NCT05270668
- Run by
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 154
- Starts
- 2022-03-29
- Expected to finish
- 2029-07-31
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Boston University School of Medicine ( Site 4021) — Boston, Massachusetts, United States
- University of Michigan Hospital ( Site 4001) — Ann Arbor, Michigan, United States
- Rutgers Robert Wood Johnson Medical School ( Site 4013) — New Brunswick, New Jersey, United States
- Hospital For Special Surgery ( Site 4020) — New York, New York, United States
- Cleveland Clinic Foundation ( Site 4019) — Cleveland, Ohio, United States
- University of Toledo Medical Center ( Site 4002) — Toledo, Ohio, United States
- University of Pittsburgh Medical Center ( Site 4016) — Pittsburgh, Pennsylvania, United States
- Medical University of South Carolina - PPDS ( Site 4004) — Charleston, South Carolina, United States
- UT Physicians Rheumatology ( Site 4007) — Houston, Texas, United States
- Froedtert and Medical College of Wisconsin ( Site 4012) — Milwaukee, Wisconsin, United States
- Consultorios Médicos Dr. Doreski ( Site 4800) — CABA, Buenos Aires, Argentina
- Clínica Privada Independencia ( Site 4802) — Munro, Buenos Aires, Argentina
- Centro de Investigación Instituto Médico Río Cuarto ( Site 4801) — Río Cuarto, Córdoba Province, Argentina
- Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803) — Rosario, Santa Fe Province, Argentina
- Royal Adelaide Hospital ( Site 4050) — Adelaide, South Australia, Australia
- Mayo Clinic - Scottsdale ( Site 4014) — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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