Platform Clinical Study for Conquering Scleroderma

Scleroderma Clinical Trial

— CONQUEST  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195072
• Other study ID #: SRF201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: November 2026

Study information

• Verified date: December 2023
• Source: Scleroderma Research Foundation, Inc.
• Contact: Kelly Oliver
• Phone: 415.834.9444
• Email: inquiries[@]conquestssc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. An enrollment cap will apply to the limited/sine cutaneous SSc subtype. The enrollment cap will allow for equal or less than 30% of limited/sine cutaneous SSc subtype study participants for each Regimen-specific Subprotocol (IP);

3. Onset of SSc (defined by first non-Raynaud's symptom) 5 years or less prior to the Screening Visit;

4. Modified Rodnan skin score (mRSS) of 10 to 35, inclusive, in participants with diffuse cutaneous SSc;

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 otherfindings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);

2. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;

3. Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study;

4. History of Child-Pugh Class B or Class C liver disease;

5. 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 >1.5 × upper limit of normal (ULN);
• Platelets <100 × 109/L (100,000/µL);
• White blood cell count <2500/µL;
• Neutrophil blood count <1500/µL;
• Prolongation of 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.

6. History of major trauma or hemorrhage within 30 days of the Screening Visit;

7. History of any clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of the Screening Visit;

8. Presence of other clinically significant risk of bleeding events, including coagulation or platelet disorders, at the Screening Visit as determined by the Investigator;

9. History of any cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of the Screening Visit;

10. History of myocardial infarction or unstable angina within 6 months of the Screening Visit, or plans to undergo a coronary procedure during participation in the study;

11. Presence of acute or chronic congestive heart failure (New York Heart Association Class III [moderate] or Class IV [severe]) at the Screening Visit; Other protocol and/or subprotocol exclusion criteria apply.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Drug:
• Amlitelimab
IP will be administered subcutaneously by the Investigator or designee as follows: Amlitelimab or Matching placebo
• BI 1015550
Study participants will take the active investigational product BI 1015550 or matching placebo provided as film-coated tablets, administered orally BID.
• Placebo
see Experimental Arm intervention description

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Alabama - Division of Pulmonary and Critical Care Medicine	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Connecticut Health	Farmington	Connecticut
United States	Northwell Health	Great Neck	New York
United States	University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics	Houston	Texas
United States	University of Kansas School of Medicine	Kansas City	Kansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Keck School of Medicine at USC Medical Center	Los Angeles	California
United States	University of California, Los Angeles (UCLA) Ronald Reagan Medical Center	Los Angeles	California
United States	Yale University School of Medicine - Epilepsy	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University (OHSU)	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Mayo Clinic	Scottsdale	Arizona
United States	Georgetown University Medical Center - Department of Rheumatology	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Scleroderma Research Foundation, Inc.	Boehringer Ingelheim, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in forced vital capacity (FVC, in mL).		from baseline to the end of the treatment period at Week 52
Secondary	The percent change in high-resolution computed tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL);	Lung involvement as measured by high-resolution computed tomography (HRCT) assessed by quantitative interstitial lung disease - whole lung (QILD-WL)	from baseline to the end of the treatment period at Week 52
Secondary	The change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea score.	Dyspnea (severity and functional limitations) are measured by the Functional Assessment of Chronic Illness Therapy (FACIT) - Dyspnea score. Dyspnea score range 0-4, total score 0-30 (higher score = worse outcome).	from baseline to the end of the treatment period at Week 52
Secondary	The proportion of study participants with an improvement in the revised CRISS score, in study participants with diffuse cutaneous SSc.		baseline, Week 52