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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)

NCT05270668

Active Not RecruitingPhase 2

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

Conditions: Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease

Interventions: Tulisokibart, Companion diagnostic ( CDx), Placebo

Countries: United States, Argentina, Australia, Belgium, Canada, Chile, France, Germany

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (95)

Phoenix, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
CABA, Buenos Aires, Argentina
Munro, Buenos Aires, Argentina
Río Cuarto, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Ghent, Oost-Vlaanderen, Belgium
Leuven, Vlaams-Brabant, Belgium
Liège, Wallonne, Region, Belgium
Edmonton, Alberta, Canada
+ 65 more on CT.gov