Amlitelimab + BI 1015550 for Scleroderma

(CONQUEST Trial)

Recruiting at 32 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

Trial Summary

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.

How is the drug Amlitelimab + BI 1015550 unique for treating scleroderma?

Amlitelimab + BI 1015550 is unique because it combines two novel agents that may target the immune system differently than existing treatments, potentially offering a new approach for managing scleroderma, a condition with limited proven therapies. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Kelly Oliver

Principal Investigator

Scleroderma Research Foundation

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of etanercept in bleomycin-induced experimental scleroderma. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Stem cell therapy in scleroderma. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Immunotherapy of systemic sclerosis. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Comparison of aminobenzoate potassium and placebo in the treatment of scleroderma. [2013]

5. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of bosentan in treatment of unresponsive cutaneous ulceration in disabling pansclerotic morphea in children. [2018]