Trial · NCT01090310

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

NCT01090310, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2016-01-14

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 NCT01090310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01090310

On this page

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: NCT01090310
Status: Terminated
Phases: Phase 3
Enrollment: 86 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Non-infectious Uveitis
Interventions: AIN457, Placebo
First posted: 2010-03-19
Last updated: 2016-01-14
Results first posted: 2016-01-14

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	Baseline to 52 weeks	Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline 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, core and extension
Secondary	Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	Baseline to 52 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
Secondary	Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension	Baseline to 52 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	Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies	Baseline to 52 weeks	Evaluation of recurrence until resolution is ascertained, based on the first criteria (a \>2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4
Secondary	Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension	Baseline to 52 weeks	IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. 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 showed better clinical outcome.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	Baseline to 52 weeks	Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had 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 were assigned to at randomization	Days	MEDIAN
SECONDARY	Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	Baseline to 52 weeks	Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had 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 were assigned to at randomization	Number of participants	NUMBER
SECONDARY	Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension	Baseline to 52 weeks	Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had 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 were assigned to at randomization	Letters	MEAN
SECONDARY	Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies	Baseline to 52 weeks	Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had 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 were assigned to at randomization	Number of participants	NUMBER
SECONDARY	Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension	Baseline to 52 weeks	Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had 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 were assigned to at randomization	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group46

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

Outcome	Group	Category	Value	Spread	Units
The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	AIN457 300mg Every 2 Weeks		NA	95% Confidence Interval 265.0 to NA	Days
The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	AIN457 300 mg Every 4 Weeks		NA	95% Confidence Interval 87.0 to NA	Days
The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	AIN457 150 mg Every 4 Weeks		NA	95% Confidence Interval 178.0 to NA	Days
The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	Placebo		NA	95% Confidence Interval 228.0 to NA	Days
Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	AIN457 300mg Every 2 Weeks	2 or more steps increase	4		Number of participants
Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	AIN457 300 mg Every 4 Weeks	2 or more steps increase	2		Number of participants
Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	AIN457 150 mg Every 4 Weeks	2 or more steps increase	1		Number of participants
Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	Placebo	2 or more steps increase	2		Number of participants
Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	AIN457 300mg Every 2 Weeks	1 step increase	4		Number of participants
Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	AIN457 300 mg Every 4 Weeks	1 step increase	8		Number of participants

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow24

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

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

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events232

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 Every 2 Weeks	1	29
other	Cataract subcapsular (Study eye)	Eye disorders	AIN457 300mg Every 4 Weeks	0	31
other	Cataract subcapsular (Study eye)	Eye disorders	AIN457 150mg Every 4 Weeks	2	31
other	Cataract subcapsular (Study eye)	Eye disorders	Placebo Every 2 Weeks	1	33
other	Conjunctivitis (Fellow eye)	Eye disorders	AIN457 300mg Every 2 Weeks	0	29
other	Conjunctivitis (Fellow eye)	Eye disorders	AIN457 300mg Every 4 Weeks	1	31
other	Conjunctivitis (Fellow eye)	Eye disorders	AIN457 150mg Every 4 Weeks	2	31
other	Conjunctivitis (Fellow eye)	Eye disorders	Placebo Every 2 Weeks	0	33
other	Cystoid macular oedema (Study eye)	Eye disorders	AIN457 300mg Every 2 Weeks	0	29
other	Cystoid macular oedema (Study eye)	Eye disorders	AIN457 300mg Every 4 Weeks	2	31

1 to 10 of 232Source ClinicalTrials.gov

See all 232 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AIN457 300mg Every 2 Weeks
Total, all-cause mortality	AIN457 300mg Every 4 Weeks
Total, all-cause mortality	AIN457 150mg Every 4 Weeks
Total, all-cause mortality	Placebo Every 2 Weeks
Total, other adverse events	AIN457 300mg Every 2 Weeks	20	29
Total, other adverse events	AIN457 300mg Every 4 Weeks	19	31
Total, other adverse events	AIN457 150mg Every 4 Weeks	22	31
Total, other adverse events	Placebo Every 2 Weeks	22	33
Total, serious adverse events	AIN457 300mg Every 2 Weeks	4	29
Total, serious adverse events	AIN457 300mg Every 4 Weeks	1	31

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT01090310

GET https://conductscience.org/api/trials/v1/NCT01090310/results?page=2

API reference For AI assistants