Overview

This trial is active, not recruiting.

Condition moderate to severe nail psoriasis
Treatments secukinumab 150 mg, secukinumab 300 mg, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date June 2013
End date January 2017
Trial size 198 participants
Trial identifier NCT01807520, 2012-005413-40, CAIN457A2313

Summary

To demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess 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)
198 patients are randomized in a 1:1:1 ratio, to receive secukinumab either 150 mg or 300 mg, or placebo. Patients assigned to secukinumab 150 mg are dosed weekly for five weeks, then once every four weeks up to and including Week 128. To maintain the blinding, patients received 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 is provided in pre-filled 1 mL syringes containing either secukinumab 150 mg or placebo secukinumab. Dosing consists of one secukinumab s.c. injection plus one placebo s.c. injection and takes 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 receive two placebo injections at Weeks 17, 18 and 19. Patients self-administer study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
(Experimental)
198 patients are randomized in a 1:1:1 ratio, to receive secukinumab either 150 mg or 300 mg, or placebo. Patients assigned to secukinumab 300 mg are dosed weekly for five weeks, then once every four weeks up to and including Week 128. To maintain the blinding, patients received 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 is provided in pre-filled 1 mL syringes containing either secukinumab 150 mg or placebo secukinumab. Dosing consists of two secukinumab s.c. injections and takes 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 receive two placebo injections at Weeks 17, 18 and 19. Patients self-administer study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
(Placebo Comparator)
198 patients are randomized in a 1:1:1 ratio, to receive secukinumab either 150 mg or 300 mg, or placebo. Patients assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo patients were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 128. All doses of study treatment are administered by sub-cutaneous injections.
placebo placebo secukinumab
Study treatment is provided in pre-filled 1 mL syringes containing either secukinumab 150 mg or placebo secukinumab. Dosing consists of two placebo s.c. injections weekly for five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Weeks 8 and 12. At Week 16, placebo patients are randomly assigned to receive either secukinumab 150 mg or secukinumab 300 mg once weekly for five weeks (at Weeks 16, 17, 18, 19 and 20), then once every four weeks, starting at Week 24 until Week 128 inclusive. Patients self-administer study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.

Primary Outcomes

Measure
Efficacy: Change in Nail Psoriasis Severity Index after 16 weeks of treatment. Each treatment group will be compared to placebo
time frame: Baseline, 16 weeks

Secondary Outcomes

Measure
Efficacy: Change in NAPSI over time up to Week 16 of the treatment compared to placebo and over time up to Week 132
time frame: 16 weeks, 132 weeks
Efficacy: Change in Psoriasis Area and Severity Index 75 (PASI75) and change in Investigator Global Assessment (IGA mod 2011) response over time up to Week 16 of the treatment compared to placebo and over time up to Week 132
time frame: 16 weeks, 132 weeks
Number of subjects in treatment groups 150 mg and 300 mg 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, including significant nail involvement, defined as Nail Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score ≥10% - 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 inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects - 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 - Exposure to 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 - 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 Longterm Efficacy up to 132 Weeks in Subjects With Moderate to Severe Nail Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.