AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT01132612
• Date of registration: 19/05/2010
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis
• Scientific title: A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis
• Date of first enrolment: May 11, 2010
• Target sample size: 275
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01132612
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

France, Germany, Iceland, Israel, Japan, Norway, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Plaque-type Psoriasis

Intervention(s)

Drug: AIN457

Drug: Placebo

Primary Outcome(s)

Number of Participants With Adverse Events, Serious Adverse Events and Deaths [Time Frame: up to week 351]

Secondary Outcome(s)

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 [Time Frame: Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)]

Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial [Time Frame: up to week 351]

Secondary ID(s)

2009-017234-51

CAIN457A2211E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01132612