Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Giant Cell Arteritis

In brief

Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: * To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: * Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time. * Cumulative CS (including prednisone) exposure. * To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA. * To measure sarilumab serum concentrations in participants with GCA. * To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

Key facts

Study ID

NCT03600805

Run by

Sanofi

People needed

83

Starts

2018-11-20

Expected to finish

2020-11-24

Last updated by the study team

2022-03-28

Who can join

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

You may qualify if…

• Diagnosis of GCA according to European League Against Rheumatism/American College of Rheumatology classification criteria.
• New onset active disease or refractory active disease.
• At least one of the symptoms of GCA within 6 weeks of baseline.
• Either erythrocyte sedimentation rate greater than or equal to (>=) 30 millimeter per hour or C-reactive protein >=10 mg per liter within 6 weeks of baseline.
• Received or were able to receive prednisone 20-60 mg/day for the treatment of active GCA.

You may not qualify if…

• Organ transplantation recipient (except corneas, unless it is within 3 months prior to baseline visit).
• Major ischemic event, unrelated to GCA, within 12 weeks of screening.
• Any prior use of the following therapies, for the treatment of GCA:
• Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.
• Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level.
• Abatacept within 8 weeks of baseline.
• Anakinra within 1 week of baseline.
• Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at least 5 half-lives had elapsed prior to baseline, whichever was longer.
• Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological Interleukin 6 (IL-6) IL-6/(R) antagonist (prior experience with IL-6/(R) antagonist that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline was not exclusionary).
• Use of any alkylating agents including cyclophosphamide within 6 months of baseline.
• Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine, mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate (MTX) not exceeding 25 mg per week and had been stable for at least 3 months prior to baseline was not exclusionary).
• Concurrent use of systemic CS for conditions other than GCA.
• Use of intervascular CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.
• Pregnant or breastfeeding woman.
• Participants with active or untreated latent tuberculosis.
• Participants with history of invasive opportunistic infections.
• Participants with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.
• Participants with uncontrolled diabetes mellitus.
• Participants with non-healed or healing skin ulcers.
• Participants who received any live, attenuated vaccine within 3 months of baseline.
• Participants who are positive for hepatitis B, hepatitis C and/or HIV.
• Participants with a history of active or recurrent herpes zoster.
• Participants with a history of or prior articular or prosthetic joint infection.
• Prior or current history of malignancy.
• Participants who have had surgery within 4 weeks of screening or planned surgery during study.

Where it is running

• Investigational Site Number 8400017 — Gainesville, Florida, United States
• Investigational Site Number 8400014 — Iowa City, Iowa, United States
• Investigational Site Number 8400018 — Portland, Oregon, United States
• Investigational Site Number 8400019 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 8400011 — Dallas, Texas, United States
• Investigational Site Number 0320001 — Buenos Aires, Argentina
• Investigational Site Number 0320002 — Caba, Argentina
• Investigational Site Number 0360003 — Camberwell, Australia
• Investigational Site Number 0360006 — Clayton, Australia
• Investigational Site Number 0360001 — Kogarah, Australia
• Investigational Site Number 0560001 — Leuven, Belgium
• Investigational Site Number 1240007 — Hamilton, Canada
• Investigational Site Number 1240010 — Montreal, Canada
• Investigational Site Number 1240001 — Rimouski, Canada
• Investigational Site Number 1240005 — Sherbrooke, Canada
• Investigational Site Number 1240003 — Trois-Rivières, Canada
• Investigational Site Number 1910001 — Zagreb, Croatia
• Investigational Site Number 2080002 — Aarhus C, Denmark
• Investigational Site Number 2080003 — Svendborg, Denmark
• Investigational Site Number 2330001 — Tallinn, Estonia
• Investigational Site Number 2500005 — Brest, France
• Investigational Site Number 2500002 — Montivilliers, France
• Investigational Site Number 2500003 — Montpellier, France
• Investigational Site Number 2500007 — Mulhouse, France
• Investigational Site Number 8400002 — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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