Status:
COMPLETED
Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis
Lead Sponsor:
Sanofi
Conditions:
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (...
Detailed Description
The total duration per participant was up to 58 weeks, which included a 2 week screening period, 16 weeks principal treatment period (Part A), 34 weeks extension treatment period (Part B) or open labe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01900431
Start Date
October 1 2013
End Date
April 1 2016
Last Update
June 20 2017
Active Locations (20)
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1
Investigational Site Number 840008
Worcester, Massachusetts, United States, 01608
2
Investigational Site Number 840009
Omaha, Nebraska, United States, 68198-5540
3
Investigational Site Number 840005
Slingerlands, New York, United States, 12159
4
Investigational Site Number 840007
Cleveland, Ohio, United States, 44195