CONQUEST: Platform Clinical Study for Conquering Scleroderma

What is the Purpose of this Study?

This study focuses on people who have systemic sclerosis (SSc, a disorder causing the tightening and hardening of the skin and internal organs) that is affecting their lungs (interstitial lung disease, SSc-ILD). The purpose of the study is to learn about the effects of experimental drugs when compared to placebo (inactive substance) for the treatment of SSc-ILD and to evaluate how safe they are for people with SSc-ILD. CONQUEST is a platform clinical trial developed by the Scleroderma Research Foundation. A platform clinical trial is a type of research study in which 2 or more treatments are assessed simultaneously, enabling researchers to add new experimental treatments to the trial as it progresses and remove others. CONQUEST is designed to rapidly advance treatments for scleroderma and identify interventions that should progress from phase 2b to phase 3 clinical trials (trials that should progress from preliminary studies to ones that evaluate treatment effectiveness). There will be multiple experimental drugs tested in the study over time. The new format will allow for multiple medications to be concurrently available in the platform, thus increasing the chances for participants to receive actual treatment. Participants will be assigned to one of these “study treatment regimens” as they are available.

Eligibility

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

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;

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 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

Show less

Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

CONQUEST 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

Study Details

Disease Type/Condition

Other

Principal Investigator

Boin, Francesco

Age Group

Adult

Phase

IRB Number

STUDY00003308

ClinicalTrials.gov ID

NCT06195072

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org