Uveitis
Conditions
Keywords
uveitis
Brief summary
A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy
Interventions
DRUGAIN457
300mg every 4 weeks
DRUGPlacebo AIN457
Placebo to AIN457
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
\-
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1. | 62 weeks | The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section . |
Countries
Egypt, France, Germany, Greece, Hong Kong, Israel, Jordan, Singapore, South Korea, Spain, Taiwan, Tunisia, Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIN457 300 mg Every 2 Weeks 300 mg every two weeks | 19 |
| AIN457 300 mg Monthly 300 mg monthly | 18 |
| AIN457 Placebo | 22 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative Problems | 18 | 17 | 15 |
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Condition no longer required study drug | 1 | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | AIN457 300 mg Every 2 Weeks | AIN457 300 mg Monthly | AIN457 Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 10.01 | 36.8 years STANDARD_DEVIATION 13.07 | 34.9 years STANDARD_DEVIATION 11.2 | 36.0 years STANDARD_DEVIATION 11.29 |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 11 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 39 | 27 / 39 | 25 / 39 |
| serious Total, serious adverse events | 7 / 39 | 8 / 39 | 5 / 39 |
Outcome results
Primary
The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1.
The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .
Time frame: 62 weeks