NCT06195072 Platform Clinical Study for Conquering Scleroderma
| NCT ID | NCT06195072 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Scleroderma Research Foundation, Inc. |
| Condition | Interstitial Lung Disease Due to Systemic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 400 participants in total. It began in 2024-04-15 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Kevin O'Shea
STUDY CHAIR
Scleroderma Research Foundation
Frequently Asked Questions
Who can join the NCT06195072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Interstitial Lung Disease Due to Systemic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06195072 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06195072 currently recruiting?
Yes, NCT06195072 is actively recruiting participants. Contact the research team at inquiries@conquestssc.org for enrollment information.
Where is the NCT06195072 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06195072 clinical trial?
NCT06195072 is sponsored by Scleroderma Research Foundation, Inc.. The principal investigator is Kevin O'Shea at Scleroderma Research Foundation. The trial plans to enroll 400 participants.