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)
Purpose
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Interstitial Lung Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tulisokibart |
Tulisokibart IV administered by IV infusion |
|
|
Placebo Comparator Placebo |
Placebo administered by IV infusion |
|
Recruiting Locations
MedStar Georgetown University Hospital ( Site 4005)
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Contact:
Study Coordinator
202-444-6200
Study Coordinator
202-444-6200
More Details
- Status
- Recruiting
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)