A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
Overview
- Phase
- Phase 3
- Intervention
- AIN457 150mg
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 967
- Locations
- 1
- Primary Endpoint
- For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AIN457150 mg- Induction period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Intervention: AIN457 150mg
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
Intervention: AIN457 300mg
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
Intervention: AIN457 150mg
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
Intervention: AIN457 300mg
AIN457 150 mg- Start of relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
Intervention: AIN457 150mg
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
Intervention: AIN457 300mg
Outcomes
Primary Outcomes
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
Time Frame: Week 40 , week 52
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)
Secondary Outcomes
- Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))(Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52)
- % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).(Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52)
- Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52(Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52)
- Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12(week 16, 20, 24,28,32,36,40,44,48,and Week 52)
- Number of Participants Developing Anti-secukinumab Antibodies(Baseline, weeks 12, 24, 52 and 60)
- Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12(Baseline, week 2, 3 , 4, 8, 12)
- % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)(Baseline to week 2, 4, 6, 8, 12)
- Median Time to Relapse (Weeks) From Week 12.(Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.)
- Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)(Baseline, week 2, 4, 6, 8, 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)(Baseline to week 2, 4, 8, 12)
- Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)(Baseline to week 2, 4, 8, 12)
- Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)(Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)(Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.)
- Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1(Week 16, 20, 24,28,32,36,40,44,48,and Week 52)
- Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy(Week 52)