Trial · NCT01032915

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

NCT01032915, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2015-11-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis. Trials, record NCT01032915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01032915

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
NCT number: NCT01032915
Status: Terminated
Phases: Phase 3
Enrollment: 125 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Non-infectious Uveitis
Interventions: AIN457, AIN457, AIN457, Placebo
First posted: 2009-12-16
Last updated: 2015-11-05
Other registries' IDs: eudract:2009-014835-19
Results first posted: 2015-11-05

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	Baseline to 24 weeks	Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baselineRecurrence of active intermediate, posterior, or panuveitis defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters
Secondary	Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks	Baseline to 24 weeks	Participants could have received up to 5 immunosuppresive agents (prednisone, cyclosporine, azathioprine, methotrexate, mycophenolate). Immunosuppressive Medication Score (IMS) is a combined, single numeric score derived on basis of total daily dose of specific immunosuppressive agents / unit body weight, ranged on a scale from 0-9 for the total daily dose in mg per kg. Patients receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment \& baseline IMS as covariate, where the lower IMS (or its reduction from baseline) showed better clinical outcome
Secondary	Mean Change in Best Corrected Visual Acuity From Baseline	Baseline to 24 weeks	The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score.
Secondary	Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks	Baseline to 24 weeks	The changes in steps (0, 1, or \>= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (\<1+ anterior chamber cell grade and \<1+ vitreous haze) for at least 2 weeks

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	Baseline to 24 weeks	Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.	Days	MEDIAN
SECONDARY	Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks	Baseline to 24 weeks	Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.	Score	MEAN
SECONDARY	Mean Change in Best Corrected Visual Acuity From Baseline	Baseline to 24 weeks	Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.	Letters	MEAN
SECONDARY	Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks	Baseline to 24 weeks	Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.	Score	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	AIN457 300mg s.c Every 2 Weeks	NA	95% Confidence Interval NA to NA	Days
Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	AIN457 300mg s.c Every 4 Weeks	NA	95% Confidence Interval 87 to NA	Days
Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	AIN457 150mg s.c Every 4 Weeks	178	95% Confidence Interval 178 to NA	Days
Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	Placebo s.c Every 2 Weeks	NA	95% Confidence Interval 170 to NA	Days
Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks	AIN457 300mg s.c Every 2 Weeks	-2.55	Standard Deviation 3.22	Score
Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks	AIN457 300mg s.c Every 4 Weeks	-2.81	Standard Deviation 2.847	Score
Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks	AIN457 150mg s.c Every 4 Weeks	-2.92	Standard Deviation 2.874	Score
Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks	Placebo s.c Every 2 Weeks	-2.13	Standard Deviation 3.049	Score
Mean Change in Best Corrected Visual Acuity From Baseline	AIN457 300mg s.c Every 2 Weeks	2.9	Standard Deviation 4.86	Letters
Mean Change in Best Corrected Visual Acuity From Baseline	AIN457 300mg s.c Every 4 Weeks	1.8	Standard Deviation 6.12	Letters

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AIN457 300mg s.c Every 2 Weeks	29
Overall Study	STARTED	AIN457 300mg s.c Every 4 Weeks	31
Overall Study	STARTED	AIN457 150mg s.c Every 4 Weeks	31
Overall Study	STARTED	Placebo s.c Every 2 Weeks	34
Overall Study	COMPLETED	AIN457 300mg s.c Every 2 Weeks	21
Overall Study	COMPLETED	AIN457 300mg s.c Every 4 Weeks	20
Overall Study	COMPLETED	AIN457 150mg s.c Every 4 Weeks	24
Overall Study	COMPLETED	Placebo s.c Every 2 Weeks	27
Overall Study	NOT COMPLETED	AIN457 300mg s.c Every 2 Weeks	8
Overall Study	NOT COMPLETED	AIN457 300mg s.c Every 4 Weeks	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events136

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cataract subcapsular (Study eye)	Eye disorders	AIN457 300mg s.c Every 2 Weeks	1	29
other	Cataract subcapsular (Study eye)	Eye disorders	AIN457 300mg s.c Every 4 Weeks	0	31
other	Cataract subcapsular (Study eye)	Eye disorders	AIN457 150mg s.c Every 4 Weeks	2	31
other	Cataract subcapsular (Study eye)	Eye disorders	Placebo s.c Every 2 Weeks	1	33
other	Conjunctivitis (Fellow eye)	Eye disorders	AIN457 300mg s.c Every 2 Weeks	0	29
other	Conjunctivitis (Fellow eye)	Eye disorders	AIN457 300mg s.c Every 4 Weeks	1	31
other	Conjunctivitis (Fellow eye)	Eye disorders	AIN457 150mg s.c Every 4 Weeks	2	31
other	Conjunctivitis (Fellow eye)	Eye disorders	Placebo s.c Every 2 Weeks	0	33
other	Dry eye (Fellow eye)	Eye disorders	AIN457 300mg s.c Every 2 Weeks	0	29
other	Dry eye (Fellow eye)	Eye disorders	AIN457 300mg s.c Every 4 Weeks	2	31

1 to 10 of 136Source ClinicalTrials.gov

See all 136 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AIN457 300mg s.c Every 2 Weeks
Total, all-cause mortality	AIN457 300mg s.c Every 4 Weeks
Total, all-cause mortality	AIN457 150mg s.c Every 4 Weeks
Total, all-cause mortality	Placebo s.c Every 2 Weeks
Total, other adverse events	AIN457 300mg s.c Every 2 Weeks	14	29
Total, other adverse events	AIN457 300mg s.c Every 4 Weeks	17	31
Total, other adverse events	AIN457 150mg s.c Every 4 Weeks	19	31
Total, other adverse events	Placebo s.c Every 2 Weeks	14	33
Total, serious adverse events	AIN457 300mg s.c Every 2 Weeks	2	29
Total, serious adverse events	AIN457 300mg s.c Every 4 Weeks	1	31

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23290985	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01032915

GET https://conductscience.org/api/trials/v1/NCT01032915/events?page=2

API reference For AI assistants