Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

• Status: Terminated
• Trial end date: 2020-11-24
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients 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 patients 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 patients with GCA.

• To measure sarilumab serum concentrations in patients with GCA.

• To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Prednisone

Criteria

Inclusion criteria :

• Diagnosis of giant cell arteritis (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 ≥30 mm/hour or C-reactive protein ≥10 mg/L within 6 weeks of baseline.

• Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.

Exclusion criteria:

• 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 have elapsed prior to baseline, whichever is longer.

• Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological 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 is 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 have been stable for at least 3 months prior to baseline is not exclusionary).

• Concurrent use of systemic corticosteroids (CS) for conditions other than GCA.

• Use of IV CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.

• Pregnant or breastfeeding woman.

• Patients with active or untreated latent tuberculosis.

• Patients with history of invasive opportunistic infections.

• Patients with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.

• Patients with uncontrolled diabetes mellitus.

• Patients with non-healed or healing skin ulcers.

• Patients who received any live, attenuated vaccine within 3 months of baseline.

• Patients who are positive for hepatitis B, hepatitis C and/or HIV.

• Patients with a history of active or recurrent herpes zoster.

• Patients with a history of or prior articular or prosthetic joint infection.

• Prior or current history of malignancy.

• Patients who have had surgery within 4 weeks of screening or planned surgery during study.

• Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation..

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.