Bosentan in the Treatment of Giant Cell Arteritis

Starting soon · Phase 2

Conditions studied: Giant Cell Arteritis (GCA)

In brief

The purpose of this study is to determine whether a treatment with 3 months of bosentan associated to standard therapy might be superior to glucocorticoids alone in term of failure free survival at 12 months

Key facts

Study ID

NCT06957002

Run by

Assistance Publique - Hôpitaux de Paris

People needed

40

Starts

2026-06-01

Expected to finish

2030-06-01

Last updated by the study team

2026-05-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients under maintenance of justice, wardship or legal guardianship
• Patient unable to give written informed consent prior to participation in the study
• Patients included in other investigational therapeutic study within the previous 3 months
• Patients suspected not to be observant to the proposed treatments
• Weight <40 Kg or > 100 Kg
• Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C. History of chronic alcohol abuse (consumption > 20 g/day)
• Severe chronic heart failure or severe systolic dysfunction
• Recent (< 3 months) or incoming surgery requiring a general anaesthesia
• History of stem cell or organ transplantation (except corneas if performed more than 3 months prior inclusion)
• Hypersensitivity to bosentan or one of its excipients
• Prior treatment with any of the following:
• Tocilizumab or methotrexate or secukinumab within 12 weeks preceding inclusion
• Cell-depleting agents (i.e., anti-CD20)
• Alkylating agents including cyclophosphamide
• Hydroxychloroquine, cyclosporine A, dapsone, azathioprine, mycophenolate mofetil or janus kinase inhibitors within 4 weeks preceding inclusion
• Tumor necrosis factor inhibitors within 8 weeks preceding inclusion
• Anakinra within 1 week preceding inclusion
• Ongoing treatment with glibenclamide, fluconazole and rifampicin. Concomitant administration of both a CYP3A4 inhibitor or a CYP2C9 inhibitor
• Long-course systemic glucocorticoid therapy for other conditions than GCA or PMR
• Laboratory abnormalities: AST or ALT >3 x upper limit of normal (ULN)
• Infections:
• Active hepatitis B or C
• HIV infection

Where it is running

• Unité de Recherche Clinique, Entrepôts de données et Pharmacologie GHU Paris Centre — Paris, France

Full record on ClinicalTrials.gov

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