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

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

More Details

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@msd.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.