Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Study duration per participant is approximately 82 weeks, including an up to 6-week screening
period, 52-week treatment period, and 24-week follow-up period.

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.