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)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study ID
NCT05270668
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Diffuse Cutaneous Systemic Sclerosis
  • Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tulisokibart — DRUG
    Tulisokibart administered at timepoints as directed by the protocol
  • Companion diagnostic ( CDx) — DIAGNOSTIC_TEST
    CDx+ or CDx-
  • Placebo — DRUG
    Placebo

Study Details

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

Key Dates

Start date
Mar 29, 2022
Status verified
May 2026
Primary completion
Apr 16, 2026
Completion
Jul 31, 2029

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tulisokibart
    Tulisokibart IV administered by IV infusion
  • Placebo Comparator: Placebo
    Placebo administered by IV infusion

Primary Outcome Measure

Number of Participants who Experience an Adverse Event (AE) [ Time Frame: Up to Week 50 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Mayo Clinic - Scottsdale ( Site 4014)PhoenixArizona85054-
Cedars Sinai Medical Center ( Site 4010)Los AngelesCalifornia90048-
Pacific Arthritis Care Center ( Site 4008)Los AngelesCalifornia90045-
UCLA School of Medicine ( Site 4006)Los AngelesCalifornia90095-1670-
Stanford Health Care ( Site 4009)Palo AltoCalifornia94304-
National Jewish Health Medical Center ( Site 4015)DenverColorado80206-
Yale University ( Site 4017)New HavenConnecticut06519-
MedStar Georgetown University Hospital ( Site 4005)Washington D.C.District of Columbia20007-
Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)BaltimoreMaryland21224-
Boston University School of Medicine ( Site 4021)BostonMassachusetts02118-
Massachusetts General Hospital ( Site 4003)BostonMassachusetts02114-
University of Michigan Hospital ( Site 4001)Ann ArborMichigan48109-
Rutgers Robert Wood Johnson Medical School ( Site 4013)New BrunswickNew Jersey08901-
Hospital For Special Surgery ( Site 4020)New YorkNew York10021-
Cleveland Clinic Foundation ( Site 4019)ClevelandOhio44195-
University of Toledo Medical Center ( Site 4002)ToledoOhio43614-
University of Pittsburgh Medical Center ( Site 4016)PittsburghPennsylvania15213-
Medical University of South Carolina - PPDS ( Site 4004)CharlestonSouth Carolina29425-
UT Physicians Rheumatology ( Site 4007)HoustonTexas77030-
Froedtert and Medical College of Wisconsin ( Site 4012)MilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic - Scottsdale· Phoenix, AZCedars Sinai Medical Center· Los Angeles, CAPacific Arthritis Care Center· Los Angeles, CAUCLA School of Medicine· Los Angeles, CAStanford Health Care· Palo Alto, CANational Jewish Health Medical Center· Denver, CO

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