AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
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| ClinicalTrials.gov Identifier: NCT00941031 |
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Recruitment Status :
Completed
First Posted : July 17, 2009
Results First Posted : March 27, 2015
Last Update Posted : August 20, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Chronic Plaque-type Psoriasis |
| Interventions |
Drug: AIN457 Drug: AIN457A Drug: Placebo |
| Enrollment | 404 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Induction Single Dose | Induction Monthly Dose | Induction Early Loading | Placebo Dose | Fixed Interval | Start of Relapse | Open Label |
|---|---|---|---|---|---|---|---|
 Arm/Group Description |
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12 | Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12 | Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12 | Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12 | Fixed-time interval regimen - "FI": secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29 | Treatment at start of relapse regimen - "SR": Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29 | Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - "OL": secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29 |
| Period Title: Induction Period | |||||||
| Started | 66 | 138 | 133 | 67 | 0 | 0 | 0 |
| Completed | 61 | 134 | 127 | 58 | 0 | 0 | 0 |
| Not Completed | 5 | 4 | 6 | 9 | 0 | 0 | 0 |
| Reason Not Completed | |||||||
| Lack of Efficacy | 2 | 1 | 0 | 5 | 0 | 0 | 0 |
| Withdrawal by Subject | 1 | 2 | 2 | 2 | 0 | 0 | 0 |
| Adminstative Problems | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
| Adverse Event | 1 | 0 | 3 | 2 | 0 | 0 | 0 |
| Period Title: Maintenance Period | |||||||
| Started | 0 [1] | 0 [1] | 0 [1] | 0 [2] | 65 [1] | 67 [1] | 247 [2] |
| Completed | 0 [1] | 0 [1] | 0 [1] | 0 [2] | 56 | 61 | 204 |
| Not Completed | 0 | 0 | 0 | 0 | 9 | 6 | 43 |
| Reason Not Completed | |||||||
| Withdrawal by Subject | 0 | 0 | 0 | 0 | 6 | 2 | 13 |
| Administrative Problems | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Adverse Event | 0 | 0 | 0 | 0 | 0 | 2 | 8 |
| Lost to Follow-up | 0 | 0 | 0 | 0 | 2 | 2 | 7 |
| Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 13 |
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[1]
Responders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
[2]
Non Responders treated with an open label regimen.
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Baseline Characteristics
| Arm/Group Title | Induction Single Dose | Induction Monthly Dose | Induction Early Loading Dose | Placebo | Total | |
|---|---|---|---|---|---|---|
|
Arm/Group Description |
Baseline through Week 12 | [Not Specified] | [Not Specified] | [Not Specified] | Total of all reporting groups | |
| Overall Number of Baseline Participants | 66 | 138 | 133 | 67 | 404 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||||
| Number Analyzed | 66 participants | 138 participants | 133 participants | 67 participants | 404 participants | |
| 42.7 (11.32) | 44.2 (12.96) | 44.5 (12.45) | 44.2 (12.59) | 44.1 (12.44) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||
| Number Analyzed | 66 participants | 138 participants | 133 participants | 67 participants | 404 participants | |
| Female |
13 19.7%
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34 24.6%
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28 21.1%
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23 34.3%
|
98 24.3%
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| Male |
53 80.3%
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104 75.4%
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105 78.9%
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44 65.7%
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306 75.7%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||
| Number Analyzed | 66 participants | 138 participants | 133 participants | 67 participants | 404 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
|
0 0.0%
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0 0.0%
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|
| Asian |
7 10.6%
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17 12.3%
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14 10.5%
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8 11.9%
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46 11.4%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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1 1.5%
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1 0.2%
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| Black or African American |
0 0.0%
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1 0.7%
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0 0.0%
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1 1.5%
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2 0.5%
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| White |
59 89.4%
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120 87.0%
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118 88.7%
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56 83.6%
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353 87.4%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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1 0.8%
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1 1.5%
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2 0.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00941031 |
| Other Study ID Numbers: |
CAIN457A2211 2008-007525-39 ( EudraCT Number ) |
| First Submitted: | July 16, 2009 |
| First Posted: | July 17, 2009 |
| Results First Submitted: | January 30, 2015 |
| Results First Posted: | March 27, 2015 |
| Last Update Posted: | August 20, 2015 |