Platform Clinical Study for Conquering Scleroderma (CONQUEST)

August 14, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Withdrawn
        • Emory University School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Completed
        • Northwestern University
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scleroderma Research Foundation, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi
Boehringer Ingelheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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