Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01365455
• Date of registration: 01/06/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year ERASURE
• Scientific title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
• Date of first enrolment: June 2011
• Target sample size: 738
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01365455
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Colombia, Estonia, Iceland, Israel, Japan, Latvia, Lithuania, Mexico, Panama, Peru, Russian Federation, Taiwan, United States

Contacts

• Name: Novartis Pharmceuticals
• Affiliation: Novartis Pharmaceuticals

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria:

- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

- Severity of psoriasis disease meeting all of the following three criteria:

- Psoriasis Area and Severity Index (PASI) score of 12 or greater,

- Investigator's Global Assessment (IGA) score of 3 or greater,

- Total body surface area (BSA) affected of 10% or greater.

- Inadequate control by prior use of topical treatment, phototherapy and/or systemic
therapy.

Exclusion criteria:

- Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
pustular, erythrodermic, guttate).

- Current drug-induced psoriasis.

- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.

- Significant medical problems such as uncontrolled hypertension, congestive heart
failure or a condition that significantly immunocompromises the subject.

- Hematological abnormalities.

- History of an ongoing, chronic or recurrent infectious disease, or evidence of
untreated tuberculosis.

- History of lymphoproliferative disease or history of malignancy of any organ system
within the past 5 years.

- Pregnant or nursing (lactating) women.

- Subjects not willing to limit UV light exposure during the study Other
protocol-defined inclusion/exclusion criteria may apply.



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

Health Condition(s) or Problem(s) studied

Moderate to Severe Plaque-type Psoriasis

Intervention(s)

Drug: placebo to secukinumab 150 mg

Drug: secukinumab 150 mg

Primary Outcome(s)

Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 [Time Frame: 12 weeks]

Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks [Time Frame: 12 weeks]

Secondary Outcome(s)

Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period [Time Frame: Week 12, 24, 36, 52]

Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo [Time Frame: Week 12]

Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period [Time Frame: Baseline, Week 1,2,3,4,8,12,]

Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period [Time Frame: Week 12,24,36, & 52]

Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12 [Time Frame: 12 and 52 weeks]

Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period [Time Frame: Baseline, Week 1,2,3,4,8,12,]

Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52 [Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52]

Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period [Time Frame: Baseline, Week 4, 8 & 12]

Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52 [Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52]

Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period [Time Frame: Baseline, Week 4,8, 12]

Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12 [Time Frame: 12 and 52 weeks]

Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-a Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-a Therapy Psoriasis Therapy [Time Frame: Week 12]

Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period [Time Frame: Week 4, 8, 12]

Number of Participants Who Developed Anti-secukinumab Antibodies [Time Frame: Week 12]

Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period [Time Frame: Week 1,2,3,4,8,12,]

Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52 [Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52]

Time to PASI 75 Response up to 12 Weeks [Time Frame: Week 12]

Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period [Time Frame: Week 12,24, 36 & 52]

Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12 [Time Frame: 12 weeks]

Secondary ID(s)

2010-023512-13

CAIN457A2302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01365455