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Taking people in United StatesPhase 2

Testing Amlitelimab and Nerandomilast Against Placebo in Scleroderma Lung Disease

Tests investigational drugs against placebo in adults with scleroderma-related lung disease.

Key facts

Who runs it
Scleroderma Research Foundation, Inc.
Where
Ann Arbor, Atlanta, Baltimore, Birmingham, Boston, Charleston, Chicago, Cleveland, Durham, Great Neck, Houston, Kansas City, Los Angeles, Milwaukee, Nashville, New Brunswick, New Haven, New York, Palo Alto, Philadelphia, Pittsburgh, Portland, Rochester, Salt Lake City, St Louis, and Washington D.C., United StatesSee the 34 sitesAlso in 11 other countries, 47 sites
Trial code
Registry title
Platform Clinical Study for Conquering Scleroderma
Status
Recruiting
Phase
Phase 2
People taking part
400 people, planned
Started
15 Apr 2024
Expected to end
Nov 2026
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Amlitelimab
  • BI 1015550 (Nerandomilast)
  • Placebo
Record updated
18 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with scleroderma (systemic sclerosis) who also have lung scarring (interstitial lung disease). It tests study drugs against placebo.

Age
18 years or older
Sex
Men and women
Disease stage
Scleroderma started 7 years or less before screening; skin score (mRSS) below 40; lung scarring seen on a chest CT scan (HRCT) in the last 3 months; lung capacity (FVC) at least 45% of predicted; gas transfer (DLCO) at least 30% of predicted.
Earlier treatment
Cannot have had rituximab in the last 6 months, or other cell-depleting therapies. Cannot have had tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, IVIG, any biologic or cyclophosphamide in the last 3 months.
Biomarker or test result
Scleroderma diagnosed by the 2013 ACR/EULAR criteria. Some blood test limits apply, such as kidney function, liver tests and blood counts.

Main reasons for not taking part

  • Past stem cell, bone marrow, CAR T-cell or solid organ transplant
  • Scleroderma kidney crisis in the last 6 months
  • Infected skin ulcers or active gangrene
  • Active tuberculosis or high risk for it
  • Life-threatening illness with life expectancy under 12 months

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Male or female 18+ years of age at the time of signed informed consent
  • SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible
  • Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit
  • A Modified Rodnan skin score (mRSS) less than 40
  • Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
  • Presence of an FVC 45% or more predicted normal
  • Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin; Other protocol and/or subprotocol inclusion criteria apply

Who cannot take part

  • Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis [TB], sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator)
  • History of scleroderma renal crisis within 6 months prior to the Screening Visit
  • History of treatment with rituximab within the 6 months prior to the Screening Visit
  • History treatment with cell-depleting therapies other than rituximab, including, but not limited to, CAMPATH®; anti-cluster of differentiation (CD)3, anti-CD4, anti-CD5, antiCD19, and anti-CD20 agents; and investigational agents
  • Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit
  • History of use of any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer) prior to Screening Visit
  • Presence of a concomitant life-threatening disease with life expectancy <12 months based on the Investigator's assessment
  • Presence of infected ulcers or active gangrene at the Screening Visit
  • History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation
  • Presence of a clinically significant disorder that, in the opinion of the Investigator, could contraindicate the administration of study product, affect compliance, interfere with study evaluations, or confound the interpretation of study results
  • Evidence of active tuberculosis (TB) or being at high risk for TB; Other protocol and/or subprotocol exclusion criteria apply
  • Presence of any of the following laboratory findings at the Screening Visit:; Estimated glomerular filtration rate <45 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration equation; Alanine aminotransferase or aspartate aminotransferase level > (2 x ULN); Platelets <100 × 109/L (100,000/μL); White blood cell count <2500/μL; Neutrophil blood count <1500/μL; Prothrombin time and partial thromboplastin time >1.5 × ULN, or international normalized ratio >2; or; Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study
  • Forced expiratory volume in 1 second/FVC <0.65 (pre-bronchodilator) at the Screening Visit

Where in United States

Also in 11 other countries, 47 sites

  • University of MichiganAnn Arbor, United StatesContact: Gabrielle KhedrTaking people
  • Emory University School of MedicineAtlanta, United StatesContact: Gabrielle KhedrNo longer taking part
  • Johns Hopkins University School Of MedicineBaltimore, United StatesContact: Gabrielle KhedrTaking people
  • University of Alabama - Division of Pulmonary and Critical Care MedicineBirmingham, United StatesContact: Gabrielle KhedrTaking people
  • Boston University (BU)Boston, United StatesContact: Gabrielle KhedrTaking people
  • Massachusetts General HospitalBoston, United StatesContact: Gabrielle KhedrTaking people
  • Medical University of South Carolina (MUSC)Charleston, United StatesContact: Gabrielle KhedrTaking people
  • The University of Chicago Medical Center (UCMC)Chicago, United StatesContact: Gabrielle KhedrTaking people
  • Northwestern UniversityChicago, United StatesContact: Gabrielle KhedrNo longer taking part
  • Cleveland ClinicCleveland, United StatesContact: Gabrielle KhedrNo longer taking part
  • Duke University Medical CenterDurham, United StatesContact: Gabrielle KhedrTaking people
  • Northwell HealthGreat Neck, United StatesContact: Gabrielle KhedrTaking people
  • University of Texas Houston - Division of Rheumatology and Clinical ImmunogeneticsHouston, United StatesContact: Gabrielle KhedrTaking people
  • University of Kansas, School of MedicineKansas City, United StatesContact: Gabrielle KhedrTaking people
  • Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Gabrielle KhedrTaking people
  • Keck School of Medicine at USC Medical CenterLos Angeles, United StatesContact: Gabrielle KhedrTaking people
  • University of California, Los Angeles (UCLA) Ronald Reagan Medical CenterLos Angeles, United StatesContact: Gabrielle KhedrNo longer taking part
  • Froedtert Hospital and the Medical College of WisconsinMilwaukee, United StatesContact: Gabrielle KhedrTaking people
  • Vanderbilt University Medical CenterNashville, United StatesContact: Gabrielle KhedrNot yet recruiting
  • Meharry Medical CollegeNashville, United StatesContact: Gabrielle KhedrNo longer taking part
  • Robert Wood Johnson Medical SchoolNew Brunswick, United StatesContact: Gabrielle KhedrTaking people
  • Yale University School of Medicine - EpilepsyNew Haven, United StatesContact: Gabrielle KhedrNo longer taking part
  • Columbia University Medical CenterNew York, United StatesContact: Gabrielle KhedrTaking people
  • Hospital for Special SurgeryNew York, United StatesContact: Gabrielle KhedrTaking people
  • Stanford University Medical CenterPalo Alto, United StatesContact: Gabrielle KhedrTaking people
  • Thomas Jefferson University HospitalPhiladelphia, United StatesContact: Gabrielle KhedrTaking people
  • University of PennsylvaniaPhiladelphia, United StatesContact: Gabrielle KhedrTaking people
  • Temple University HospitalPhiladelphia, United StatesContact: Gabrielle KhedrNo longer taking part
  • University of Pittsburgh Medical CenterPittsburgh, United StatesContact: Gabrielle KhedrNo longer taking part
  • Oregon Health &amp; Science University (OHSU)Portland, United StatesContact: Gabrielle KhedrTaking people
  • Mayo ClinicRochester, United StatesContact: Gabrielle KhedrTaking people
  • The University of Utah Health Sciences CenterSalt Lake City, United StatesContact: Gabrielle KhedrNo longer taking part
  • Washington University School of MedicineSt Louis, United StatesContact: Gabrielle KhedrNo longer taking part
  • Georgetown University Medical Center - Department of RheumatologyWashington D.C., United StatesContact: Gabrielle KhedrTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • AmlitelimabTreatment being tested
  • Amlitelimab matching placeboPlacebo, for comparison

    Treatment: Placebo

  • BI 1015550 (Nerandomilast)Treatment being tested
  • BI 1015550 (Nerandomilast) matching placeboPlacebo, for comparison

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants With Interstitial Lung Disease Secondary to Systemic Sclerosis
Plain-language title
Testing Amlitelimab and Nerandomilast Against Placebo in Scleroderma Lung DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
18 August 2026