Platform Clinical Study for Conquering Scleroderma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Scleroderma Research Foundation, Inc.
Study ID
NCT06195072
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Interstitial Lung Disease Due to Systemic Disease
  • Scleroderma

Eligibility Criteria

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

Interventions

  • Amlitelimab — DRUG
    IP will be administered subcutaneously by the Investigator or designee as follows: * Amlitelimab or * Matching placebo
  • BI 1015550 (Nerandomilast) — DRUG
    Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.
  • Placebo — DRUG
    see Experimental Arm intervention description

Study Details

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

Key Dates

Start date
Apr 15, 2024
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amlitelimab
  • Placebo Comparator: Amlitelimab matching placebo
  • Experimental: BI 1015550 (Nerandomilast)
  • Placebo Comparator: BI 1015550 (Nerandomilast) matching placebo

Primary Outcome Measure

The change in forced vital capacity (FVC, in mL). [ Time Frame: from baseline to the end of the treatment period at Week 52 ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
University of Alabama - Division of Pulmonary and Critical Care MedicineBirminghamAlabama35294-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Keck School of Medicine at USC Medical CenterLos AngelesCalifornia90033-
University of California, Los Angeles (UCLA) Ronald Reagan Medical CenterLos AngelesCalifornia90095-7436-
Stanford University Medical CenterPalo AltoCalifornia94305-
Yale University School of Medicine - EpilepsyNew HavenConnecticut06520-
Georgetown University Medical Center - Department of RheumatologyWashington D.C.District of Columbia20007-
Emory University School of MedicineAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637-
University of Kansas School of MedicineKansas CityKansas66160-
Johns Hopkins University School of MedicineBaltimoreMaryland21224-
Boston University (BU)BostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-0370-
Mayo ClinicRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-
Northwell HealthGreat NeckNew York11021-
Columbia University Medical CenterNew YorkNew York10032-
Hospital for Special SurgeryNew YorkNew York10021-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Oregon Health & Science University (OHSU)PortlandOregon97239-
Temple University HospitalPhiladelphiaPennsylvania19140-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15219-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29404-
Meharry Medical CollegeNashvilleTennessee37208-
Vanderbilt University Medical CenterNashvilleTennessee37208-
University of Texas Houston - Division of Rheumatology and Clinical ImmunogeneticsHoustonTexas77030-
The University of Utah Health Sciences CenterSalt Lake CityUtah84112-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama - Division of Pulmonary and Critical Care Medicine· Birmingham, ALCedars-Sinai Medical Center· Los Angeles, CAKeck School of Medicine at USC Medical Center· Los Angeles, CAUniversity of California, Los Angeles (UCLA) Ronald Reagan Medical Center· Los Angeles, CAStanford University Medical Center· Palo Alto, CAYale University School of Medicine - Epilepsy· New Haven, CT

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