Overview

This trial is active, not recruiting.

Condition moderate to severe palmoplantar psoriasis
Treatments secukinumab 150 mg, secukinumab 300 mg, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date June 2013
End date November 2016
Trial size 205 participants
Trial identifier NCT01806597, 2012-005412-25, CAIN457A2312

Summary

Purpose of the study is to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
201 subjects will be randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 150 mg will be dosed weekly for the first five weeks, then every four weeks up to and including Week 128. To maintain blinding, subjects will receive additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.
secukinumab 150 mg AIN457 150 mg
Study treatment will be provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consists of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and will take place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients will also receive two placebo injections at Weeks 17, 18 and 19. Patients will self-administer study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
(Experimental)
201 subjects will be randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 300 mg will be dosed weekly for the first five weeks and then every four weeks up to and including Week 128. In order to maintain the blinding, subjects will receive additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.
secukinumab 300 mg AIN457 300 mg
Study treatment will be provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consists of two secukinumab 150 mg s.c. injections and will take place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients will also receive two placebo injections at Weeks 17, 18 and 19. Patients will self-administer study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
(Placebo Comparator)
201 subjects will be randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects on placebo will dose weekly for 5 weeks then once every 4 weeks. At Week 16, ppIGA responders will continue to receive placebo weekly for 5 weeks starting at Week 16, then every 4 weeks up to and including Week 76 while ppIGA non-responders will be randomized in a 1:1 ratio to secukinumab either 150 mg or 300mg weekly for 5 weeks, starting at Week 16, then every 4 weeks up to and including Week 128. At Week 80, subjects on placebo will either terminate their participation, if ppIGA responders, or be randomized in a 1:1 ratio to secukinumab either 150 mg or 300 mg once every 4 weeks until Week 128 inclusive. All doses of study treatment are administered by sub-cutaneous injections.
placebo
Placebo will be provided in 1 mL pre-filled syringes. Each dosing consists of two s.c. injections and will take place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders will continue on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders will end their participation in the study while ppIGA non-responders will be re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients will self-administer study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.

Primary Outcomes

Measure
Efficacy:palmoplantar Investigator Global Assessmnet (ppIGA) response after 16 weeks of treatment. Each of the treatment groups will be compared to placebo.
time frame: Baseline, 16 weeks

Secondary Outcomes

Measure
Efficacy: palmoplantar Investigator Global Assessment (ppIGA) response over time up to Week 16, and over time up to Week 80 or Week 132
time frame: 16 weeks, 132 weeks
Efficacy: palmoplantar Psoriasis Area and Severity Index (ppPASI) over time up to Week 16 compared to placebo, and over time up to Week 132
time frame: 16 weeks, 132 weeks
Number of subjects in treatment groups 150mg and 300mg with adverse events, safety labs, ECG, and vital signs as a measure of safety and tolerability
time frame: Baseline, up to 140 weeks
Number and percentage of subjects who develop immunogenicity against secukinumab
time frame: Baseline, 32 weeks, 80 weeks, 132 weeks, 88 weeks or 140 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months prior to randomization and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area - Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy Exclusion Criteria: - Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis) - Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium) - Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply. - Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor - Use of any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer - Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy - History of hypersensitivity to constituents of the study treatment - Other protocol-defined inclusion/exclusion criteria do apply

Additional Information

Official title A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Palmoplantar Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Novartis.