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Testing new treatments for lung disease caused by scleroderma

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

Phase 2 Interventional Scleroderma Research Foundation, Inc. · NCT06195072

This study is testing new treatments for lung disease caused by scleroderma to see if they can improve lung function in adults with this condition.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorScleroderma Research Foundation, Inc. Academic / other
Drugs / interventionsrituximab, tocilizumab, tofacitinib, chimeric antigen receptor, cyclophosphamide
Locations34 sites (Birmingham, Alabama and 33 other locations)
Trial IDNCT06195072 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of various investigational products, including Amlitelimab and BI 1015550, compared to a placebo in improving lung capacity in patients with Interstitial Lung Disease secondary to systemic sclerosis. Participants will be monitored over a 52-week treatment period to assess changes in lung function. The study includes adults aged 18 and older who meet specific criteria related to their scleroderma diagnosis and lung health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of scleroderma and evidence of interstitial lung disease.

Not a fit: Patients with significant pulmonary abnormalities unrelated to interstitial lung disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved treatment options for patients suffering from lung complications due to scleroderma.

How similar studies have performed: Other studies have explored treatments for scleroderma-related lung disease, but this specific platform approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female 18+ years of age at the time of signed informed consent;
2. 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
3. Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;
4. A Modified Rodnan skin score (mRSS) less than 40
5. Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
6. Presence of an FVC 45% or more predicted normal;
7. 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.

Exclusion Criteria:

1. 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);
2. Presence of infected ulcers or active gangrene at the Screening Visit;
3. History of scleroderma renal crisis within 6 months prior to the Screening Visit;
4. Forced expiratory volume in 1 second/FVC \<0.65 (pre-bronchodilator) at the Screening Visit
5. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
6. History of treatment with rituximab within the 6 months prior to the Screening Visit;
7. 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
8. Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit
9. 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.
10. 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.
11. 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
12. Presence of a concomitant life-threatening disease with life expectancy \<12 months based on the Investigator's assessment;
13. Evidence of active tuberculosis (TB) or being at high risk for TB

Other protocol and/or subprotocol exclusion criteria apply.

Where this trial is running

Birmingham, Alabama and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Interstitial Lung Disease Due to Systemic DiseaseSclerodermaplatformsclerodermainterstitial lung diseasesystemic sclerosisSScSSc-ILD
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.