Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis
Condition: Uveitis
MeSH terms: Uveitis
Intervention: Sarilumab; Prednisone; Methotrexate; Folic/folinic acid; Placebo (for Sarilumab)
Intervention description: Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous; Pharmaceutical form: Tablet or Capsule; Route of administration: Oral; Pharmaceutical form: Tablet or Capsule or Suspension; Route of administration: Orally or intravenously or intramuscular; Pharmaceutical form: Tablet or Capsule; Route of administration: Oral; Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous
Intervention MeSH terms: Leucovorin; Folic Acid; Prednisone; Methotrexate; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis
      (NIU).

      Secondary Objectives:

      To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of
      subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. To
      evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal
      vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant
      therapy.

      To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the
      pharmacokinetics of sarilumab in NIU participants. To evaluate the immunogenicity with
      anti-drug antibodies (ADA).
    

Eligibility criteria:

        Inclusion criteria:

          -  ≥18 years of age.

          -  Non-infectious intermediate, posterior, or pan-uveitis in the study eye.

          -  Active disease at screening or evidence of activity within the 3 months prior to
             screening visit. Following the approval of amendment-2, only participants with "active
             disease" as defined above were enrolled in the study.

          -  Starting oral prednisone dose must be greater than or equal to 15 mg/day and less than
             80 mg/day.

          -  At screening, participants must be receiving oral prednisone (≥15 mg and <80 mg/day
             [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in
             combination with MTX (≤25 mg/week) orally or intravenously or intramuscular or
             subcutaneous). -

          -  Participants could be receiving one or several of the following therapies:
             Azathioprine (≤2.5 mg/kg/day), Mycophenolate mofetil (≤2 g daily, orally),
             Cyclosporine (≤4 mg/kg daily, orally), Tacrolimus (≤4 mg daily, orally).

          -  The doses might not had been increased for at least 4 weeks prior to the randomization
             visit.

          -  At randomization, participants had been receiving oral prednisone (≥15 mg and <80
             mg/day [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in
             combination with MTX (≤25 mg/week) orally or intravenously or intramuscular or
             subcutaneous).

          -  Azathioprine, mycophenolate mofetil, cyclosporine and tacrolimus had to be permanently
             discontinued at least 48 hours prior to the first study treatment injection, or longer
             as per Investigator's judgment. These immunomodulatory therapies (IMTs) were not
             permitted anytime during the treatment period.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Participants with best-corrected visual acuity (BCVA) worse than 20 early treatment
             diabetic retinopathy study (ETDRS) letters in at least one eye.

          -  Participants with confirmed or suspected uveitis of infectious etiology or uveitis of
             traumatic etiology.

          -  Participants with primary diagnosis of anterior uveitis.

          -  Prior treatment with anti-interleukin-6 (IL-6) or interleukin-6 receptor complex
             (IL-6R) antagonist therapies, including tocilizumab and sarilumab.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.