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
Zusammenfassung der Studie
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
(BASEC)
Untersuchte Intervention
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.
(BASEC)
Untersuchte Krankheit(en)
The lung disease associated with systemic sclerosis (SSc), known as interstitial lung disease (shortened to SSc-ILD).
(BASEC)
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)
Ausschlusskriterien
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)
Studienstandort
Zürich
(BASEC)
Sponsor
Scleroderma Research Foundation Medpace Switzerland AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr.med. Carmen-Marina Mihai
+41 (0)43 254 14 39
carmen-marina.mihai@clutterusz.chUniversity Hospital Zürich, Department of Rheumatology
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.12.2024
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
nicht verfügbar
Öffentlicher Titel
nicht verfügbar
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
nicht verfügbar
Studiendesign
nicht verfügbar
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
nicht verfügbar
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar