Trial · NCT01095250
Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
NCT01095250, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2015-11-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis. Trials, record NCT01095250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01095250
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 Active Non-infectious Uveitis
- NCT number
- NCT01095250
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Uveitis
- Interventions
- AIN457, AIN457, AIN457, Placebo
- First posted
- 2010-03-30
- Last updated
- 2015-11-03
- Results first posted
- 2015-11-03
- Limitations and caveats
Study CAIN457C2302 was terminated to avoid continuing patients on a study with a low probability of success. Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier. | baseline to 28 weeks | No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. |
| Secondary | Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks | baseline to 28 weeks | No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. |
| Secondary | Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks | baseline to 28 weeks | No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. |
| Secondary | Change From Baseline in Quality of Life/Patient Reported Outcome Assessments | baseline to 28 weeks | No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. |
| Secondary | Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks | baseline to 28 weeks | No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. |
| Secondary | Change in Immunosuppressive Medication Score From Baseline to Week 28 | baseline to 28 weeks | No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier. | baseline to 28 weeks | The results of Study CAIN457C2303 did not meet the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success. | ||
| SECONDARY | Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks | baseline to 28 weeks | |||
| SECONDARY | Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks | baseline to 28 weeks | |||
| SECONDARY | Change From Baseline in Quality of Life/Patient Reported Outcome Assessments | baseline to 28 weeks | |||
| SECONDARY | Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks | baseline to 28 weeks | |||
| SECONDARY | Change in Immunosuppressive Medication Score From Baseline to Week 28 | baseline to 28 weeks |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AIN457 300mg s.c Every 2 Weeks | 8 | |
| Overall Study | STARTED | AIN457 300mg s.c. Every 4 Weeks | 10 | |
| Overall Study | STARTED | AIN457 150mg s.c Every 4 Weeks | 8 | |
| Overall Study | STARTED | Placebo s.c Every 2 Weeks | 5 | |
| Overall Study | COMPLETED | AIN457 300mg s.c Every 2 Weeks | 0 | |
| Overall Study | COMPLETED | AIN457 300mg s.c. Every 4 Weeks | 0 | |
| Overall Study | COMPLETED | AIN457 150mg s.c Every 4 Weeks | 0 | |
| Overall Study | COMPLETED | Placebo s.c Every 2 Weeks | 0 | |
| Overall Study | NOT COMPLETED | AIN457 300mg s.c Every 2 Weeks | 8 | |
| Overall Study | NOT COMPLETED | AIN457 300mg s.c. Every 4 Weeks | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events172
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 | Events |
|---|---|---|---|---|---|---|
| other | Blepharitis (Fellow eye) | Eye disorders | AIN457 300mg Every 2 Weeks | 0 | 8 | |
| other | Blepharitis (Fellow eye) | Eye disorders | AIN457 300mg Every 4 Weeks | 0 | 10 | |
| other | Blepharitis (Fellow eye) | Eye disorders | AIN457 150mg Every 4 Weeks | 0 | 8 | |
| other | Blepharitis (Fellow eye) | Eye disorders | Placebo Every 2 Weeks | 1 | 4 | |
| other | Blepharitis (Study eye) | Eye disorders | AIN457 300mg Every 2 Weeks | 0 | 8 | |
| other | Blepharitis (Study eye) | Eye disorders | AIN457 300mg Every 4 Weeks | 0 | 10 | |
| other | Blepharitis (Study eye) | Eye disorders | AIN457 150mg Every 4 Weeks | 0 | 8 | |
| other | Blepharitis (Study eye) | Eye disorders | Placebo Every 2 Weeks | 1 | 4 | |
| other | Cataract (Fellow eye) | Eye disorders | AIN457 300mg Every 2 Weeks | 0 | 8 | |
| other | Cataract (Fellow eye) | Eye disorders | AIN457 300mg Every 4 Weeks | 0 | 10 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse 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 | 6 | 8 |
| Total, other adverse events | AIN457 300mg Every 4 Weeks | 4 | 10 |
| Total, other adverse events | AIN457 150mg Every 4 Weeks | 6 | 8 |
| Total, other adverse events | Placebo Every 2 Weeks | 4 | 4 |
| Total, serious adverse events | AIN457 300mg Every 2 Weeks | 1 | 8 |
| Total, serious adverse events | AIN457 300mg Every 4 Weeks | 1 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
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.
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/NCT01095250
GET https://conductscience.org/api/trials/v1/NCT01095250/events?page=2