Interstitial Lung Disease Due to Systemic DiseasePhase 2CONQUESTNCT06195072
Platform Clinical Study for Conquering Scleroderma
A Phase 2 study testing Amlitelimab and BI 1015550 (Nerandomilast) in people with Interstitial Lung Disease Due to Systemic Disease and Scleroderma, run by Scleroderma Research Foundation, Inc. at 34 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease Due to Systemic Disease, Scleroderma
- What is being tested?
- Amlitelimab and BI 1015550 (Nerandomilast)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 34 sitesUnited States
- Study dates
- 15 Apr 2024to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Other protocol and/or subprotocol inclusion criteria apply.
Who cannot join
- 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;
Show all 21Show fewer
- 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;
- 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.
- 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.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
United States34 sites, 24 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109-0370
- Withdrawn
Emory University School of Medicine
Atlanta, Georgia, 30322
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
- Recruiting
University of Alabama - Division of Pulmonary and Critical Care Medicine
Birmingham, Alabama, 35294
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Boston University (BU)
Boston, Massachusetts, 02215
- Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29404
- Completed
Northwestern University
Chicago, Illinois, 60611
- Recruiting
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
- Withdrawn
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
Northwell Health
Great Neck, New York, 11021
- Recruiting
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
Houston, Texas, 77030
- Recruiting
University of Kansas School of Medicine
Kansas City, Kansas, 66160
- Recruiting
Keck School of Medicine at USC Medical Center
Los Angeles, California, 90033
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Withdrawn
University of California, Los Angeles (UCLA) Ronald Reagan Medical Center
Los Angeles, California, 90095-7436
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Withdrawn
Meharry Medical College
Nashville, Tennessee, 37208
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37208
- Recruiting
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
- Withdrawn
Yale University School of Medicine - Epilepsy
New Haven, Connecticut, 06520
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
- Recruiting
Columbia University Medical Center
New York, New York, 10032
- Recruiting
Stanford University Medical Center
Palo Alto, California, 94305
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
- Withdrawn
Temple University Hospital
Philadelphia, Pennsylvania, 19140
- Withdrawn
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
- Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Withdrawn
The University of Utah Health Sciences Center
Salt Lake City, Utah, 84112
- Withdrawn
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Georgetown University Medical Center - Department of Rheumatology
Washington D.C., District of Columbia, 20007
About this study
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
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.
- Being tested
- Amlitelimab, BI 1015550 (Nerandomilast), Placebo
- Keywords
- platform, scleroderma, interstitial lung disease, systemic sclerosis, SSc, SSc-ILD
- Medical subject headings
- Scleroderma, Diffuse, Lung Diseases, Interstitial, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlitelimabDrug
IP will be administered subcutaneously by the Investigator or designee as follows:
- Amlitelimab or
- Matching placebo
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.
PlaceboDrug
see Experimental Arm intervention description
| Study group | Role | What they receive |
|---|---|---|
| Amlitelimab | Experimental | Not described Receives: Drug: Amlitelimab |
| Amlitelimab matching placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BI 1015550 (Nerandomilast) | Experimental | Not described Receives: Drug: BI 1015550 (Nerandomilast) |
| BI 1015550 (Nerandomilast) matching placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in forced vital capacity (FVC, in mL).
Measured: 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);
Lung involvement as measured by high-resolution computed tomography (HRCT) assessed by quantitative interstitial lung disease - whole lung (QILD-WL)
Measured: from baseline to the end of the treatment period at Week 52
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).
Measured: 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.
Measured: baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start15 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Disease Due to Systemic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scleroderma Research Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Kevin O'Shea, Study chair, Scleroderma Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195072
- Sponsor's protocol ID
- SRF201
- Acronym
- CONQUEST
- Status last verified
- Oct 2025
- First submitted
- 22 Dec 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39544897
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06195072
- Acronym / sponsor ID
- CONQUEST / SRF201
- Keywords
- platform, scleroderma, interstitial lung disease, systemic sclerosis, SSc, SSc-ILD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Scleroderma Research Foundation, Inc.University, hospital or other
- Collaborators
- Sanofi, Boehringer Ingelheim
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Amlitelimab | Experimental | Drug: Amlitelimab |
| Amlitelimab matching placebo | Placebo comparator | Drug: Placebo |
| BI 1015550 (Nerandomilast) | Experimental | Drug: BI 1015550 (Nerandomilast) |
| BI 1015550 (Nerandomilast) matching placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlitelimabIP will be administered subcutaneously by the Investigator or designee as follows: * Amlitelimab or * Matching placebo | Drug | Amlitelimab |
| 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. | Drug | BI 1015550 (Nerandomilast) |
| Placebosee Experimental Arm intervention description | Drug | Amlitelimab matching placebo, BI 1015550 (Nerandomilast) matching placebo |
Primary outcome
The change in forced vital capacity (FVC, in mL).
Time frame: from baseline to the end of the treatment period at Week 52
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 39544897Khanna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin O'Shea study chair
Scleroderma Research Foundation
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amlitelimab and BI 1015550 (Nerandomilast) in people with Interstitial Lung Disease Due to Systemic Disease and Scleroderma, run by Scleroderma Research Foundation, Inc. at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabrielle Khedr (415.834.9444, inquiries@conquestssc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in forced vital capacity (FVC, in mL). (time frame: from baseline to the end of the treatment period at Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06195072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.