Platform Clinical Study for Conquering Scleroderma (CONQUEST)

February 2, 2026 updated by: Scleroderma Research Foundation, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama - Division of Pulmonary and Critical Care Medicine
        • Contact:
        • Contact:
          • Tracy Luckhardt
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Francesco Boin
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck School of Medicine at USC Medical Center
        • Contact:
        • Principal Investigator:
          • Toby Maher
      • Los Angeles, California, United States, 90095-7436
        • Withdrawn
        • University of California, Los Angeles (UCLA) Ronald Reagan Medical Center
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
        • Contact:
        • Principal Investigator:
          • Lorinda Chung
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Withdrawn
        • Yale University School of Medicine - Epilepsy
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center - Department of Rheumatology
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School Of Medicine
        • Contact:
        • Principal Investigator:
          • Srihari Veeraraghavan
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Contact:
          • Carrie Richardson
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago Medical Center (UCMC)
        • Contact:
        • Principal Investigator:
          • Iazsmin Bauer Ventura
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas School of Medicine
        • Contact:
        • Principal Investigator:
          • Mark Hamblin
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins University School of Medicine
        • Contact:
        • Principal Investigator:
          • Laura Hummers
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Contact:
          • Flavia Castelino
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Boston University (BU)
        • Contact:
        • Contact:
          • Marcin Trojanowski
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0370
        • Recruiting
        • University of Michigan
        • Contact:
          • Dinesh Khanna
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Ashima Makol
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Withdrawn
        • Washington University School of Medicine
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson Medical School
        • Contact:
        • Principal Investigator:
          • David Roofeh
    • New York
      • Great Neck, New York, United States, 11021
        • Recruiting
        • Northwell Health
        • Contact:
        • Contact:
          • Sonali Narain
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
        • Contact:
          • Jessica Gordon
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Contact:
          • Elana Bernstein
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Ankoor Shah
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Withdrawn
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University (OHSU)
        • Contact:
        • Contact:
          • Julianna Desmarais
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Nora Sandorfi
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Withdrawn
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15219
        • Withdrawn
        • University Of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29404
        • Recruiting
        • Medical University of South Carolina (MUSC)
        • Contact:
        • Principal Investigator:
          • Faye Hant
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Withdrawn
        • Meharry Medical College
      • Nashville, Tennessee, United States, 37208
        • Not yet recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
        • Contact:
          • Zsuzsanna McMahan
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Withdrawn
        • The University of Utah Health Sciences Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital and the Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Mary Ellen Csuka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlitelimab
Drug: Amlitelimab

IP will be administered subcutaneously by the Investigator or designee as follows:

  • Amlitelimab or
  • Matching placebo
Placebo Comparator: Amlitelimab matching placebo
Drug: Placebo
see Experimental Arm intervention description
Experimental: BI 1015550 (Nerandomilast)
Drug: BI 1015550 (Nerandomilast)
Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.
Placebo Comparator: BI 1015550 (Nerandomilast) matching placebo
Drug: Placebo
see Experimental Arm intervention description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in forced vital capacity (FVC, in mL).
Time Frame: from baseline to the end of the treatment period at Week 52
from baseline to the end of the treatment period at Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percent change in high-resolution computed tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL);
Time Frame: from baseline to the end of the treatment period at Week 52
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
The change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea score.
Time Frame: from baseline to the end of the treatment period at Week 52
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.
Time Frame: baseline, Week 52
baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scleroderma Research Foundation, Inc.

Collaborators

Sanofi
Boehringer Ingelheim

Investigators

  • Study Chair: Kevin O'Shea, Scleroderma Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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