Phase 2
N=275
AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis
Plaque-type Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01132612 ↗Enrolled (actual)
275
Serious AEs
20.4%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Adverse Events, Serious Adverse Events and Deaths — 44; 41; 180; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AIN457 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events, Serious Adverse Events and Deaths |
44; 41; 180; 9; 4; 43 | — |
| SECONDARY Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response |
43; 34; 163; 31; 16; 102 | — |
| SECONDARY Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial |
0; 0; 1 | — |
Summary
The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.
Eligibility Criteria
Key Inclusion Criteria
- Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4) of the core study
- Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed.
- Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator
- Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration Note: Due to new data available from the toxicology studies, the need for male contraception was removed.
Key Exclusion Criteria
- Patients who experience a second consecutive full relapse at visit 13 ( week F4) of the core study CAIN457A2211
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (> 5mlU/mL)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
Data sourced from ClinicalTrials.gov (NCT01132612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.