CONQUEST Clinical Platform Study to Combat Scleroderma: A multicenter, double-blind, randomized, placebo-controlled phase 2b clinical platform study to assess the safety and efficacy of investigational products in participants with interstitial lung disease due to systemic sclerosis
Summary description of the study
Systemic sclerosis (SSc) is a rare chronic disease that affects the skin and internal organs. The lungs are affected in the majority of patients with SSc. The lung disease associated with SSc is referred to as interstitial lung disease (shortened to SSc-ILD). This study platform allows for the investigation of different investigational products under the same conditions, which can be adjusted over time. Through this study platform, the development of new drugs for SSc-ILD is accelerated, namely (a) by parallel testing of multiple drugs and (b) by reducing the number of study participants needed for significant results. The study design also assigns fewer participants to a placebo, allowing more participants to potentially benefit from the active drug. Some participants may need to interrupt some of their stable standard therapies for SSc-ILD. In the event of an unexpected
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Intervention under investigation
Participants will be randomly assigned to one of the available treatment regimens: currently either Amlitelimab/placebo or BI 1015550/placebo. Amlitelimab is a monoclonal antibody (laboratory-made protein). It is intended to bind to a protein called OX40 ligand, which alters the function of certain cells in the immune system, and inhibit it. The OX40 ligand is believed to play an important role in the scarring process. Individuals who have received Amlitelimab in other studies reported the following side effects: headaches, fatigue, upper respiratory tract infection, flu-like illness, nausea, fever, sore throat, diarrhea, vomiting, excessive sweating (hyperhidrosis), and pain at the injection site. BI 1015550 inhibits the protein PDE4B, which contributes to the coordination of the fibrotic process (scarring) in the lung. BI 1015550 also appears to be beneficial in another (but similar) lung disease.
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Disease under investigation
The lung disease associated with systemic sclerosis (SSc), known as interstitial lung disease (shortened to SSc-ILD).
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The study will include men and women aged 18 years and older, who have been diagnosed with SSc within 5 years prior to study enrollment and the presence of SSc-ILD has been confirmed in the 3 months prior to the start of study treatment. (BASEC)
Exclusion criteria
1. Presence of clinically significant lung abnormalities that are not consistent with ILD (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/researcher) 2. Previous stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or organ transplantation 3. Women who are pregnant, breastfeeding, or planning a pregnancy during the clinical study (BASEC)
Trial sites
Zurich
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Sponsor
Scleroderma Research Foundation Medpace Switzerland AG
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Contact
Contact Person Switzerland
PD Dr.med. Carmen-Marina Mihai
+41 (0)43 254 14 39
carmen-marina.mihai@clutterusz.chUniversity Hospital Zürich, Department of Rheumatology
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Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
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Date of authorisation
20.12.2024
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ICTRP Trial ID
not available
Official title (approved by ethics committee)
CONQUEST 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 (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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