Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2029
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05270668
Start Date
March 29 2022
End Date
July 31 2029
Last Update
October 17 2025
Active Locations (95)
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1
Mayo Clinic - Scottsdale ( Site 4014)
Phoenix, Arizona, United States, 85054
2
Pacific Arthritis Care Center ( Site 4008)
Los Angeles, California, United States, 90045
3
Cedars Sinai Medical Center ( Site 4010)
Los Angeles, California, United States, 90048
4
UCLA School of Medicine ( Site 4006)
Los Angeles, California, United States, 90095-1670