Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01412944
• Date of registration: 05/08/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis STATURE
• Scientific title: A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab
• Date of first enrolment: December 2011
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01412944
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Austria, Bulgaria, Canada, Czech Republic, France, Germany, India, Italy, Japan, Poland, Slovakia, Switzerland, Taiwan, United States, Vietnam

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria:

- Written Informed Consent must be obtained before any assessment is performed,

- Subject must be able to understand and communicate with the investigator and comply
with the requirements of the study.

- Subjects must have participated in the study CAIN457A2304 and have achieved a partial
response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved = PASI 50 but < 75 response.

Exclusion criteria

- Pregnant women or lactating women

- Forms of psoriasis other than chronic plaque -type

- Ongoing use of prohibited psoriasis treatments

- Ongoing use of other non-psoriasis prohibited treatments

- Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor,
except secukinumab in study CAIN457A2304

- Active ongoing inflammation diseases other than psoriasis that might confound the
evaluation of the benefits of secukinumab therapy

- UV therapy or excessive exposure to sunlight



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

Health Condition(s) or Problem(s) studied

Plaque-type Psoriasis

Intervention(s)

Drug: secukinumab 10mg/kg i.v. regimen

Drug: secukinumab 150mg

Primary Outcome(s)

Percentage of Participants (Who Achieved a Partial Response Defined as = 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI [Time Frame: Week 8]

Percentage of Participants (Who Achieved a Partial Response Defined as = 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response [Time Frame: Week 8]

Secondary Outcome(s)

Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores [Time Frame: Baseline, weeks 8, 16, 24, 32 and 40]

Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) [Time Frame: Baseline, weeks 8, 16, 24, 32 and 40]

Mean Percent Change From Baseline in PASI Scores [Time Frame: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40]

Number of Participants Who Developed Anti-secukinumab Antibodies [Time Frame: Baseline, weeks 12, 24 and 40]

Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 [Time Frame: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40]

Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy [Time Frame: End of study]

Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40]

Percentage of Participants in Each IGA Mod 2011 Score Category [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40]

Secondary ID(s)

CAIN457A2307

2011-002510-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01412944