Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis (SARILNIUSATURN)
Uveitis
About this trial
This is an interventional treatment trial for Uveitis
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.
Sites / Locations
- Investigational Site Number 840008
- Investigational Site Number 840009
- Investigational Site Number 840005
- Investigational Site Number 840007
- Investigational Site Number 840006
- Investigational Site Number 203001
- Investigational Site Number 203002
- Investigational Site Number 250001
- Investigational Site Number 250002
- Investigational Site Number 380001
- Investigational Site Number 380003
- Investigational Site Number 380004
- Investigational Site Number 724003
- Investigational Site Number 724001
- Investigational Site Number 792001
- Investigational Site Number 792005
- Investigational Site Number 792002
- Investigational Site Number 792003
- Investigational Site Number 792004
- Investigational Site Number 792006
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Sarilumab 200 mg q2w
Placebo (for Sarilumab) subcutaneous (SC) injection every 2 weeks (q2w) for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with Methotrexate (MTX) 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).