Amlitelimab + BI 1015550 for Scleroderma

(CONQUEST Trial)

Recruiting at 34 trial locations

Overseen By Kelly Oliver

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Scleroderma Research Foundation, Inc.

Must not be taking: Rituximab, Tocilizumab, Nintedanib, others

Disqualifiers: Pulmonary abnormalities, Infected ulcers, Renal crisis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for individuals with lung problems caused by scleroderma, a condition that hardens skin and other tissues. Researchers are testing two experimental drugs, Amlitelimab and BI 1015550 (also known as Nerandomilast), to determine if they can improve lung function over a year compared to a placebo. The trial seeks participants who have had scleroderma for 7 years or less and have lung issues confirmed by recent imaging. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you have not used certain medications like rituximab, tocilizumab, nintedanib, and others within 6 months before the screening. If you are currently on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that amlitelimab is generally safe for humans. A recent study found no new safety issues, confirming its safety over a year. Most patients responded well and maintained their health improvements.

For BI 1015550, also known as nerandomilast, studies have found it to be safe and well-tolerated. Testing in a controlled environment demonstrated its effectiveness without major problems. Safety data suggests it can be used safely with medical supervision.

Both treatments have undergone thorough testing, and current evidence supports their safety for use in clinical trials. Participants can feel reassured about the careful assessment of these treatments' safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Amlitelimab and BI 1015550 for scleroderma because they offer potential new ways to tackle this challenging condition. Unlike current treatments like immunosuppressants and corticosteroids, which primarily aim to reduce inflammation, Amlitelimab is a monoclonal antibody that targets a specific immune pathway, potentially offering a more precise approach to managing the disease. BI 1015550, known as Nerandomilast, is a novel PDE4 inhibitor that may help control fibrosis, a major issue in scleroderma, by blocking enzymes involved in the fibrosis process. Together, these treatments introduce innovative mechanisms that could improve outcomes for patients beyond what standard therapies currently achieve.

What evidence suggests that this trial's treatments could be effective for Interstitial Lung Disease Secondary to Systemic Sclerosis?

Research has shown that amlitelimab, one of the treatments in this trial, has produced very positive results in treating conditions like atopic dermatitis. A large study achieved all its main goals, suggesting it might help manage inflammation and immune responses, which are important in scleroderma. Meanwhile, BI 1015550, also known as nerandomilast, has slowed the decline of lung function in other lung diseases. This drug blocks certain enzymes that cause inflammation and scarring in the lungs. Both treatments have strong scientific support for their potential to help with lung problems related to systemic sclerosis. ^{1 3 6 7 8}

Who Is on the Research Team?

Kelly Oliver

Principal Investigator

Scleroderma Research Foundation

Are You a Good Fit for This Trial?

This trial is for individuals with Interstitial Lung Disease due to Systemic Sclerosis, a type of scleroderma affecting the lungs. Participants should have measurable lung disease at the start and be able to perform certain lung function tests.

Inclusion Criteria

My skin thickness score is between 10 and 35.

My condition meets the 2013 criteria for systemic sclerosis.

My first symptom of scleroderma appeared less than 5 years ago.

Exclusion Criteria

I haven't had a heart attack or unstable chest pain in the last 6 months, nor do I plan to have heart surgery during the study.

I have had moderate to severe liver disease.

I have had a stem cell, bone marrow, CAR T-cell therapy, or organ transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive investigational products or placebo to evaluate efficacy on lung capacity over 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab
• BI 1015550
• Placebo

Trial Overview The study is testing two potential treatments: Amlitelimab and BI 1015550, against a placebo. The main goal is to see if these treatments can improve lung capacity after one year compared to no treatment (placebo).

How Is the Trial Designed?

Group I: BI 1015550 (Nerandomilast) Experimental Treatment 1 Intervention

Group II: Amlitelimab Experimental Treatment 1 Intervention

Group III: BI 1015550 (Nerandomilast) matching placebo Placebo Group 1 Intervention

Group IV: Amlitelimab matching placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Scleroderma Research Foundation, Inc.

Lead Sponsor

Trials

1

Recruited

400+

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

A 48-week study involving 146 patients with scleroderma found that aminobenzoate potassium (KPAB) did not significantly improve skin mobility or thickening compared to a placebo, indicating it may not be effective for this condition.

While KPAB was generally well tolerated, with a compliance rate of over 75%, some patients experienced adverse drug reactions, primarily gastrointestinal issues and headaches, leading to withdrawals from the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of aminobenzoate potassium and placebo in the treatment of scleroderma. Clegg, DO., Reading, JC., Mayes, MD., et al.[2013]

Cyclophosphamide is the primary treatment for progressive skin involvement and active interstitial lung disease in scleroderma, while mycophenolate mofetil shows promise as an alternative.

Newer therapies targeting T-cells (like sirolimus and alefacept) and B-cells (like rituximab) have shown encouraging results in small studies, but the safety and efficacy of antifibrotic treatments like imatinib still need further confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of systemic sclerosis. Manno, R., Boin, F.[2022]

Scleroderma, particularly in its early diffuse form, has a high mortality rate and currently lacks proven therapies, highlighting the urgent need for effective treatment options.

Stem cell therapy, supported by recent pilot studies, shows promise as a potential treatment for scleroderma, with ongoing controlled studies in Europe and upcoming trials in the United States to further evaluate its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem cell therapy in scleroderma. Braun-Moscovici, Y., Furst, DE.[2019]

In a study involving 32 mice with bleomycin-induced scleroderma, etanercept significantly reduced markers of dermal sclerosis, including serum TGF-beta1 levels and collagen accumulation, indicating its potential efficacy in managing scleroderma.

Thalidomide did not show significant effects in this model, suggesting that targeting TNF-alpha with etanercept may be a more effective approach for treating the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of etanercept in bleomycin-induced experimental scleroderma. Koca, SS., Isik, A., Ozercan, IH., et al.[2015]

A 4-year-old girl with disabling pansclerotic morphea showed significant improvement in skin lesions, joint mobility, and reduction in skin thickness after 4 weeks of treatment with the endothelin receptor antagonist bosentan, indicating its potential efficacy.

No side effects were reported during the treatment, suggesting that bosentan may be a safe and promising option for managing this rare and severe form of localized scleroderma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of bosentan in treatment of unresponsive cutaneous ulceration in disabling pansclerotic morphea in children. Roldan, R., Morote, G., Castro, Mdel C., et al.[2018]

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170

Press Release: Sanofi's amlitelimab met all primary and ... Sanofi's amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39544897/

Design of CONQUEST, a novel, randomized, placebo ... The first molecules to be studied, amlitelimab and nerandomilast, both have a strong scientific rationale to modify underlying disease processes in systemic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06195072

Platform Clinical Study for Conquering Scleroderma 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11893482/

Comparative Efficacy of Immunosuppressive Therapies in the ... Our findings robustly support routine use of MMF in dcSSc and show benefit especially in early‐stage disease.

5. dermatologytimes.com dermatologytimes.com/view/sanofi-s-ox40l-inhibitor-amlitelimab-shows-positive-results-in-phase-3-ad-trial

Sanofi's OX40L Inhibitor Amlitelimab Shows Positive ... Amlitelimab achieved all primary and secondary endpoints in the COAST 1 phase 3 study, showing significant efficacy in treating moderate to ...

6. academic.oup.com academic.oup.com/bjd/article-abstract/191/Supplement_2/ljae266.039/7728690

661 - Efficacy and safety of amlitelimab, an anti-OX40 ligand ... Clinically meaningful efficacy with amlitelimab was demonstrated over 52-Weeks, with an acceptable safety profile. Clinical responses were maintained in most ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9314635/

OX40L Inhibition Suppresses KLH‐driven Immune Responses ... The safety, tolerability, immunogenicity, and pharmacokinetic (PK) profile of an anti‐OX40L monoclonal antibody (KY1005, currently amlitelimab) were evaluated.

8. sigma.larvol.com sigma.larvol.com/product.php?e1=628274&tab=newstrac

amlitelimab IV (SAR445229) News Interim RIVER-AD results demonstrated clinical improvements after 28 weeks of subcutaneous 250mg Q4W amlitelimab treatment in participants with moderate-to- ...