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Purpose

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

Conditions

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

ArmDescriptionAssigned Intervention
Experimental
Tulisokibart 		Tulisokibart IV administered by IV infusion
  • Drug: Tulisokibart
    Tulisokibart administered at timepoints as directed by the protocol
    Other names:
    • PRA023
    • MK-7240
  • Diagnostic Test: Companion diagnostic ( CDx)
    CDx+ or CDx-
Placebo Comparator
Placebo 		Placebo administered by IV infusion
  • Diagnostic Test: Companion diagnostic ( CDx)
    CDx+ or CDx-
  • Drug: Placebo
    Placebo

Recruiting Locations

Mayo Clinic - Scottsdale ( Site 4014)
Phoenix, Arizona 85054
Contact:
Study Coordinator
480-301-8368

University of Michigan Hospital ( Site 4001)
Ann Arbor, Michigan 48109
Contact:
Study Coordinator
734-232-2090

UT Physicians Rheumatology ( Site 4007)
Houston, Texas 77030
Contact:
Study Coordinator
713-500-6900

Medical University of South Carolina - PPDS ( Site 4004)
Charleston, South Carolina 29425
Contact:
Study Coordinator
843-792-7093

University of Pittsburgh Medical Center ( Site 4016)
Pittsburgh, Pennsylvania 15213
Contact:
Study Coordinator
412-647-6700

University of Toledo Medical Center ( Site 4002)
Toledo, Ohio 43614
Contact:
Study Coordinator
419-383-4271

Cleveland Clinic Foundation ( Site 4019)
Cleveland, Ohio 44195
Contact:
Study Coordinator
216-444-9945

Hospital For Special Surgery ( Site 4020)
New York, New York 10021
Contact:
Study Coordinator
212-774-2123

Rutgers Robert Wood Johnson Medical School ( Site 4013)
New Brunswick, New Jersey 08901
Contact:
Study Coordinator
732-418-8484

Boston University School of Medicine ( Site 4021)
Boston, Massachusetts 02118
Contact:
Study Coordinator
617-358-6784

Pacific Arthritis Care Center ( Site 4008)
Los Angeles, California 90045
Contact:
Study Coordinator
310-297-6812

Massachusetts General Hospital ( Site 4003)
Boston, Massachusetts 02114
Contact:
Study Coordinator
617-726-7938

Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
Baltimore, Maryland 21224
Contact:
Study Coordinator
410-550-7715

MedStar Georgetown University Hospital ( Site 4005)
Washington, District of Columbia 20007
Contact:
Study Coordinator
202-444-6200

Yale University ( Site 4017)
New Haven, Connecticut 06519
Contact:
Study Coordinator
877-925-3637

National Jewish Health Medical Center ( Site 4015)
Denver, Colorado 80206
Contact:
Study Coordinator
303-270-2631

Stanford Health Care ( Site 4009)
Palo Alto, California 94304
Contact:
Study Coordinator
650-723-6961

UCLA School of Medicine ( Site 4006)
Los Angeles, California 90095-1670
Contact:
Study Coordinator
310-825-2448

Cedars Sinai Medical Center ( Site 4010)
Los Angeles, California 90048
Contact:
Study Coordinator
415-502-3475

Froedtert and Medical College of Wisconsin ( Site 4012)
Milwaukee, Wisconsin 53226
Contact:
Study Coordinator
414-805-7390

More Details

NCT ID
NCT05270668
Status
Recruiting
Sponsor
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center