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Not yet recruitingPhase 2

Bosentan added to steroid treatment for giant cell arteritis

Tests bosentan plus glucocorticoids versus glucocorticoids alone in people with giant cell arteritis.

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
France17 sites in 1 countryChoose a country to see its sites
Registry title
Bosentan in the Treatment of Giant Cell Arteritis
Status
Not yet recruiting
Phase
Phase 2
People taking part
40 people, planned
Started
Jun 2026
Expected to end
Jun 2030
Type of study
Interventional, 2 groups
Treatments tested
  • Bosentan
  • Glucocorticoids
Record updated
6 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 50 or older with newly diagnosed or relapsing giant cell arteritis (GCA), an inflammation of large arteries. The disease must be active. It compares bosentan plus glucocorticoids (steroids) with glucocorticoids alone.

Age
50 Years and older (at least 50 years at disease onset)
Sex
All. Women who still had periods in the past 24 months must use an effective non-hormonal birth control and have a negative urine pregnancy test.
Disease stage
GCA confirmed by a temporal artery biopsy or by scans showing inflamed large arteries. Active GCA within 2 weeks before entry: ESR ≥30 mm/h or CRP ≥10 mg/L plus head symptoms, polymyalgia rheumatica symptoms or other signs of a flare.
Earlier treatment
Cannot have had tocilizumab, methotrexate or secukinumab within 12 weeks, TNF inhibitors within 8 weeks, or hydroxychloroquine, cyclosporine A, dapsone, azathioprine, mycophenolate mofetil or janus kinase inhibitors within 4 weeks. Cannot have had anakinra within 1 week. Cannot have ever had anti-CD20 drugs or alkylating agents such as cyclophosphamide.
Biomarker or test result
Past ESR ≥ 50 mm/h or CRP ≥ 20 mg/L, unless the biopsy is positive.

Main reasons for not taking part

  • Weight <40 Kg (88 lb) or > 100 Kg (220 lb)
  • Moderate to severe liver disease (Child-Pugh B or C), chronic alcohol abuse, or AST or ALT >3 x upper limit of normal
  • Severe chronic heart failure or severe weak heart pumping
  • Past stem cell or organ transplant (corneas more than 3 months ago are allowed)
  • Active hepatitis B or C, or HIV infection

The registry criteria, word for word

Show all 28 criteriaShow less

Who cannot take part

  • 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
  • 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)
  • 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
  • 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
  • Hypersensitivity to bosentan or one of its excipients
  • Long-course systemic glucocorticoid therapy for other conditions than GCA or PMR
  • Infections:; Active hepatitis B or C; HIV infection
  • Laboratory abnormalities: AST or ALT >3 x upper limit of normal (ULN)
  • Patients under maintenance of justice, wardship or legal guardianship
  • Patients suspected not to be observant to the proposed treatments
  • Weight <40 Kg or > 100 Kg

Other criteria

  • Inclusion Criteria :
  • Patients having given their written informed consent prior to participation in the study
  • Patients affiliated with social security or CMU (profit or being entitled)
  • Diagnosis of GCA, as defined by the revised GCA diagnosis criteria. Patients must satisfy criteria 1-2-3 and 4 (irrespective of time):; Age ≥50 years at disease onset; History of erythrocyte sedimentation rate (ESR) ≥ 50 mm/h or CRP ≥ 20 mg/L (not mandatory if TAB is positive: see below); At least one of the following:
  • unequivocal cranial symptoms of GCA (new onset headache, scalp tenderness, jaw claudication, temporal artery abnormality, ischemia-related vision loss)
  • unequivocal symptoms of polymyalgia rheumatica (PMR); At least one of the following:
  • Temporal artery biopsy (TAB) compatible with the diagnosis of GCA (non-necrotizing vasculitis with a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells)
  • Evidence of large vessel vasculitis:; angio-CT or angio-MRI: thickened and/or contrast-enhanced arteries especially aorta (≥2mm) and epiaortic arteries (≥1mm) and contrast enhanced arteries in T1-weighted sequences; or PET scan: ≥ grade 2 (from 0 to 3) tracer uptake on large arteries
  • At least a sign of active GCA within the 2 weeks prior to randomisation. Active GCA is defined by ESR ≥30 mm/h or CRP ≥10 mg/L and at least one of the following:
  • unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
  • unequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
  • other features judged by the clinical investigator to be consistent with GCA or PMR flares
  • Menopausal women (no gynaecological cycle over the past two years), or women who had a gynaecological cycle within previous 24 months (non-menopausal women) only if they have (1) an effective non hormonal contraceptive method throughout study and (2) a negative urinary beta-hCG test at inclusion

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Bosentan + GlucocorticoidsTreatment being tested

    Bosentan : 62.5 mg bid for 4 weeks and 125 mg bid during 9 additional weeks Glucocorticoids : prespecified GC tapering schedule

    Treatment: Bosentan

  • GlucocorticoidsOther group

    prespecified GC tapering schedule

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Bosentan in the Treatment of Giant Cell Arteritis. Multicenter, Randomized, Controlled, Superiority Phase II Trial Comparing a Combination of Bosentan and Glucocorticoids Versus Glucocorticoids Alone in the Treatment of Patients With GCA
Plain-language title
Bosentan added to steroid treatment for giant cell arteritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
6 May 2026