Safety and Efficacy of AIN457 in Noninfectious Uveitis
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ClinicalTrials.gov Identifier: NCT00685399 |
Recruitment Status :
Completed
First Posted : May 28, 2008
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
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Condition or disease | Intervention/treatment | Phase |
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Non-infectious Uveitis | Drug: AIN457 Drug: AIN 457 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Proof-of-concept Study With a Double-masked, Dose-ranging Component to Assess the Effects of AIN457 in Patients With Noninfectious Uveitis |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
Participants were administered with AIN457 (Sp2/0derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22.
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Drug: AIN457
AIN457 subcutaneous dose
Other Name: Secukinumab |
Experimental: Cohort 2
Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
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Drug: AIN457
AIN457 subcutaneous dose
Other Name: Secukinumab |
Experimental: Cohort 3
Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
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Drug: AIN 457
AIN457 low dose (i.v)
Other Name: Secukinumab |
Experimental: Cohort 4
Extension period: Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
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Drug: AIN 457
AIN457 low dose (i.v)
Other Name: Secukinumab |
Experimental: Cohort 5
Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
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Drug: AIN457
AIN457 high dose (i.v)
Other Name: Secukinumab |
Experimental: Cohort 6 Arm 1
Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
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Drug: AIN457
AIN457 high dose (i.v)
Other Name: Secukinumab |
Experimental: Cohort 6 Arm 2
Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
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Drug: AIN 457
AIN457 low dose (i.v)
Other Name: Secukinumab |
Experimental: Cohort 6 Arm 3
Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
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Drug: AIN457
AIN457 high dose (i.v)
Other Name: Secukinumab |
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died [ Time Frame: Day 1 to Day 603 ]AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
- Number of Responders in Cohort 1, 2, 3 and 6 at Day 57 [ Time Frame: Day 1 (Baseline), Day 57 ]A "responder" was defined as a participant who fulfilled at least one of the 3 criteria compared to baseline: 1. Increase in visual acuity by at least 15 letters using Early Treatment Diabetic Retinopathy Study method, no increase in daily prednisone dose compared to week 1 and without worsening of uveitis. 2. Decrease in vitreous haze by 2 steps or more or for participants with anterior uveitis, resolution of the anterior chamber inflammation (i.e., no cells or only a rare cell in the anterior chamber (score 0 or trace (0.5+)), use measurement before dilation), no increase in daily prednisone dose compared to week 1 and without any worsening of uveitis.3 For those participant on a. >20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 10 mg/day or less. b. ≤20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 0 mg/day. c. topical corticosteroids during week 1: Reduction in daily topical corticosteroid dose to 0 during the last 2 weeks.
- Number of Complete Responders in Cohort 2, 3 and 6 at Day 57 [ Time Frame: Day 1 (Baseline), Day 57 ]A "complete responder" was defined as a participant who was able to stop all topical and systemic corticosteroids in both eyes and maintain remission of uveitis (=remains a responder as defined above) lasting at least 1 week (since stopping corticosteroids, if corticosteroids were given).
- Number of Participants With Reduction in Oral Prednisone or Topical Corticosteroid and Other Immunosuppressant Drugs [ Time Frame: Baseline (Day 1) up to Month 8 ]Participants intake of oral prednisone or topical corticosteroid and other immunosuppressant drugs was reduced if participant was on up to 1.5 mg/kg/day dose of prednisone during the week prior to Day 1 or whom the resumption of prednisone was not considered the appropriate systemic therapy by investigator or who have never been on systemic immunosuppressive therapy and whose uveitis was so severe that, in the clinician's judgment, prednisone at a dose of 1.0-1.5 mg/kg/day alone will be insufficient to control the uveitis or participant with HLA-B27-associated anterior uveitis who would ordinarily be started on systemic prednisone. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.
- Number of Participants Who Were Able to Induce a Remission in Uveitis [ Time Frame: Day 1 to Day 85 ]Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes by Day 57 visit after the first course of one or two doses of AIN457 were to be categorized as nonresponders and were to be discontinued from the study at the Day 85 visit. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.
- Number of Participants With Remission in Uveitis [ Time Frame: Baseline (Day 1) up to Month 8 ]Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes after the first course of one or two doses by Day 57 visit . The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.
- Number of Participants Who Were Able to Re-induce a Remission if a Flare-up Occurs [ Time Frame: Day 1 to Day 57 ]A flare was defined as an increase of inflammation in either eye so that the anterior chamber cell score or the vitreous haze score become 1+ or greater. Vitreous haze was evaluated with an indirect ophthalmoscope and a hand-held 20-diopter lens. Haze is defined as a reduction in the clarity of fundus details seen through the vitreous, the degree of haze was quantified using standard National Eye Institute (NEI) photographs. The standard photographs provide a grading scale with photographs of fundi with vitreous haze grades "0" (zero), "trace" (which counts as 0.5+), 1+, 2+, 3+, and 4+. If the amount of vitreous haze appears to fall between two integer grades, the value would be recorded as halfway between the grades. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685399
United States, California | |
Novartis Investigative Site | |
Beverly Hills, California, United States, 90211 | |
Novartis Investigative Site | |
Los Angeles, California, United States, 90033 | |
Novartis Investigative Site | |
Sacramento, California, United States, 95819 | |
United States, Colorado | |
Novartis Investigative Site | |
Denver, Colorado, United States, 80210 | |
Novartis Investigative Site | |
Golden, Colorado, United States, 80401 | |
Novartis Investigative Site | |
Littleton, Colorado, United States, 80120 | |
United States, Georgia | |
Novartis Investigative Site | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Novartis Investigative Site | |
Baltimore, Maryland, United States, 21201 | |
Novartis Investigative Site | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Novartis Investigative Site | |
Cambridge, Massachusetts, United States, 02142 | |
United States, Missouri | |
Novartis Investigative Site | |
Kansas City, Missouri, United States, 64111 | |
United States, New Jersey | |
Novartis Investigative Site | |
Teaneck, New Jersey, United States, 07666 | |
United States, New York | |
Novartis Investigative Site | |
New York, New York, United States, 10022 | |
Novartis Investigative Site | |
Slingerlands, New York, United States, 12159 | |
United States, North Carolina | |
Novartis Investigative Site | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Novartis Investigative Site | |
Cleveland, Ohio, United States, 44195 | |
United States, South Carolina | |
Novartis Investigative Site | |
Spartanburg, South Carolina, United States, 29306 | |
United States, Texas | |
Novartis Investigative Site | |
Arlington, Texas, United States, 76012 | |
Novartis Investigative Site | |
Austin, Texas, United States, 78793 | |
Novartis Investigative Site | |
Houston, Texas, United States, 77030 | |
Germany | |
Novartis Investigative Site | |
Berlin, Germany, 13353 | |
Novartis Investigative Site | |
Heidelberg, Germany, 691120 | |
Novartis Investigative Site | |
Tübingen, Germany, 72076 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00685399 |
Other Study ID Numbers: |
CAIN457A2208 2011-001243-67 ( EudraCT Number ) |
First Posted: | May 28, 2008 Key Record Dates |
Results First Posted: | July 17, 2017 |
Last Update Posted: | July 17, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Uveitis eye IL-17 IL-17A IL17 AIN457 Vogt-Koyanagi-Harada Behcet's Behcet Sympathetic ophthalmia |
Multifocal choroiditis Birdshot HLA-B27 Birdshot retinochoroiditis Retinal vasculitis Sarcoidosis Intermediate uveitis Panuveitis Posterior uveitis |
Uveitis Uveal Diseases Eye Diseases |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |