Platform Clinical Study for Conquering Scleroderma
CONQUEST
1 other identifier
interventional
400
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2024
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedStudy Start
First participant enrolled
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
February 4, 2026
October 1, 2025
2.5 years
December 22, 2023
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in forced vital capacity (FVC, in mL).
from baseline to the end of the treatment period at Week 52
Secondary Outcomes (3)
The percent change in high-resolution computed tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL);
from baseline to the end of the treatment period at Week 52
The change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea score.
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
Study Arms (4)
Amlitelimab
EXPERIMENTALAmlitelimab matching placebo
PLACEBO COMPARATORBI 1015550 (Nerandomilast)
EXPERIMENTALBI 1015550 (Nerandomilast) matching placebo
PLACEBO COMPARATORInterventions
IP will be administered subcutaneously by the Investigator or designee as follows: * Amlitelimab or * Matching placebo
Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.
see Experimental Arm intervention description
Eligibility Criteria
You may qualify if:
- Male or female 18+ years of age at the time of signed informed consent;
- 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
- Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;
- A Modified Rodnan skin score (mRSS) less than 40
- Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
- Presence of an FVC 45% or more predicted normal;
- Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin;
You may not qualify if:
- 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:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanoficollaborator
- Boehringer Ingelheimcollaborator
- Scleroderma Research Foundation, Inc.lead
Study Sites (34)
University of Alabama - Division of Pulmonary and Critical Care Medicine
Birmingham, Alabama, 35294, United States
Keck School of Medicine at USC Medical Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Los Angeles (UCLA) Ronald Reagan Medical Center
Los Angeles, California, 90095-7436, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
Yale University School of Medicine - Epilepsy
New Haven, Connecticut, 06520, United States
Georgetown University Medical Center - Department of Rheumatology
Washington D.C., District of Columbia, 20007, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637, United States
University of Kansas School of Medicine
Kansas City, Kansas, 66160, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University (BU)
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109-0370, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Northwell Health
Great Neck, New York, 11021, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29404, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37208, United States
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
Houston, Texas, 77030, United States
The University of Utah Health Sciences Center
Salt Lake City, Utah, 84112, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 39544897DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kevin O'Shea
Scleroderma Research Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2023
First Posted
January 8, 2024
Study Start
April 15, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
February 4, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share