Phase 2
N=16
Safety and Efficacy of AIN457 in Noninfectious Uveitis
Non-infectious Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT00685399 ↗Enrolled (actual)
16
Serious AEs
2.8%
Results posted
Jul 2017
Primary outcome: Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died — 0; 0; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AIN457 (Drug); AIN 457 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died |
0; 0; 1; 1; 0; 1 | — |
| SECONDARY Number of Responders in Cohort 1, 2, 3 and 6 at Day 57 |
0; 1; 0; 1; 1; 3 | — |
| SECONDARY Number of Complete Responders in Cohort 2, 3 and 6 at Day 57 |
0; 0; 0; 1; 1; 1 | — |
| SECONDARY Number of Participants With Reduction in Oral Prednisone or Topical Corticosteroid and Other Immunosuppressant Drugs |
— | — |
| SECONDARY Number of Participants Who Were Able to Induce a Remission in Uveitis |
— | — |
| SECONDARY Number of Participants With Remission in Uveitis |
— | — |
| SECONDARY Number of Participants Who Were Able to Re-induce a Remission if a Flare-up Occurs |
— | — |
Summary
This study was performed to evaluate the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.
Eligibility Criteria
Inclusion criteria
- Active uveitis (i.e., uveitis that is not in remission).
- Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated.
Exclusion criteria
- Active infection.
- Weight must not be greater that 120kg.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00685399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.