Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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.

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

Keywords

Interstitial Lung Disease Due to Systemic Disease, Scleroderma, platform, interstitial lung disease, systemic sclerosis, SSc, SSc-ILD, Lung Diseases, Interstitial Lung Diseases, Systemic Scleroderma, Diffuse Scleroderma, Localized Scleroderma, Amlitelimab

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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 6 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.

Locations

  • University of California, Los Angeles (UCLA) Ronald Reagan Medical Center not yet accepting patients
    Los Angeles California 90095-7436 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Keck School of Medicine at USC Medical Center not yet accepting patients
    Los Angeles California 90033 United States
  • Oregon Health &amp; Science University (OHSU) accepting new patients
    Portland Oregon 97239 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Scleroderma Research Foundation, Inc.
ID
NCT06195072
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated