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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlitelimab | Experimental |
| |
| Amlitelimab matching placebo | Placebo Comparator |
| |
| BI 1015550 (Nerandomilast) | Experimental |
| |
| BI 1015550 (Nerandomilast) matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlitelimab | Drug | IP will be administered subcutaneously by the Investigator or designee as follows:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in forced vital capacity (FVC, in mL). | from baseline to the end of the treatment period at Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Other protocol and/or subprotocol inclusion criteria apply.
Exclusion Criteria:
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);
Presence of infected ulcers or active gangrene at the Screening Visit;
History of scleroderma renal crisis within 6 months prior to the Screening Visit;
Forced expiratory volume in 1 second/FVC <0.65 (pre-bronchodilator) at the Screening Visit
History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
History of treatment with rituximab within the 6 months prior to the Screening Visit;
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
Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit
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.
Presence of any of the following laboratory findings at the Screening Visit:
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
Presence of a concomitant life-threatening disease with life expectancy <12 months based on the Investigator's assessment;
Evidence of active tuberculosis (TB) or being at high risk for TB
Other protocol and/or subprotocol exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabrielle Khedr | Contact | 415.834.9444 | inquiries@conquestssc.org | |
| Kevin O'Shea | Contact | 415.834.9444 | inquiries@conquestssc.org |
| Name | Affiliation | Role |
|---|---|---|
| Kevin O'Shea | Scleroderma Research Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Division of Pulmonary and Critical Care Medicine | Recruiting | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39544897 | Derived | Khanna D, Evnin LB, Assassi S, Benton WW, Gordon G, Maslova K, Steffgen J, Maher TM. Design of CONQUEST, a novel, randomized, placebo-controlled, Phase 2b platform clinical trial to investigate new treatments for patients with early active systemic sclerosis with interstitial lung disease. J Scleroderma Relat Disord. 2024 Nov 5;10(2):121-132. doi: 10.1177/23971983241278079. eCollection 2025 Jun. |
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Participants who have given informed consent for the Master Protocol and all available Regimen-specific Subprotocols for which they are eligible will be randomly assigned to a regimen. Within each regimen, participants will be assigned to active treatment or matching placebo in a ratio detailed in the randomization scheme.
Eligibility for the Regimen will be based on the inclusion and exclusion criteria in the Master Protocol and on the inclusion and exclusion criteria in the Regimen-specific Subprotocol.
Importantly, to preserve the integrity of randomization, participants will be consented to all possible Regimen-specific Subprotocols open at that time, for which they qualify. Eligible participants will then be randomized to only one Regimen-specific Subprotocol, followed by randomization to the active IP treatment or to the corresponding placebo within a Regimen-specific Subprotocol.
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There will be multiple interventional regimens, each consisting of the study participants receiving either the active IP or its matching placebo. Study participants, Investigators, and site staff will not be blinded to the regimen assignment, but they will be blinded to active product or matching placebo assignment. Enrollment to regimens may start at different time points during the study.
| BI 1015550 (Nerandomilast) | Drug | Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID. |
|
| Placebo | Drug | see Experimental Arm intervention description |
|
| 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 |
| The proportion of study participants with an improvement in the revised CRISS score, in study participants with diffuse cutaneous SSc and baseline mRRS ≥10. | baseline, Week 52 |
| Keck School of Medicine at USC Medical Center | Recruiting | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
| University of California, Los Angeles (UCLA) Ronald Reagan Medical Center | Withdrawn | Los Angeles | California | 90095-7436 | United States |
| Stanford University Medical Center | Recruiting | Palo Alto | California | 94305 | United States |
| Yale University School of Medicine - Epilepsy | Withdrawn | New Haven | Connecticut | 06520 | United States |
| Georgetown University Medical Center - Department of Rheumatology | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| Emory University School of Medicine | Recruiting | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| The University of Chicago Medical Center (UCMC) | Recruiting | Chicago | Illinois | 60637 | United States |
| University of Kansas School of Medicine | Recruiting | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins University School of Medicine | Recruiting | Baltimore | Maryland | 21224 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Boston University (BU) | Recruiting | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109-0370 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | Withdrawn | St Louis | Missouri | 63110 | United States |
| Robert Wood Johnson Medical School | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| Northwell Health | Recruiting | Great Neck | New York | 11021 | United States |
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Withdrawn | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University (OHSU) | Recruiting | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Withdrawn | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Medical Center | Withdrawn | Pittsburgh | Pennsylvania | 15219 | United States |
| Medical University of South Carolina (MUSC) | Recruiting | Charleston | South Carolina | 29404 | United States |
| Meharry Medical College | Withdrawn | Nashville | Tennessee | 37208 | United States |
| Vanderbilt University Medical Center | Not yet recruiting | Nashville | Tennessee | 37208 | United States |
| University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics | Recruiting | Houston | Texas | 77030 | United States |
| The University of Utah Health Sciences Center | Withdrawn | Salt Lake City | Utah | 84112 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| D017563 | Lung Diseases, Interstitial |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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