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 (CAIN457A2312)

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 (CAIN457A2312) - CAIN457A2312

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44761

Enrollment

Registered

2013-04-10

Start date

2013-08-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis

Interventions

Treatment with Secukinumab (150 or 300 mg) or placebo s.c 4-weekly. Placebo till week 80, as of week 80 secukinumab 4-weekly 150 of 300 mg s.c. (no placebo-arm anymore)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male or female patients at least 18 years of age. *Chronic moderate to severe plaque type psoriasis for at least 6 months with: - significant involvement of palms and soles defined by a ppIGA score of > 3. - at least one extra palmoplantar plaque on the skin. * Candidate for systemic therapy, defined as having psoriasis considered inadequately controlled by: - Topical treatment (including super potent topical corticosteroid) and/or - Phototherapy and/or - Previous systemic therapy.

Exclusion criteria

Exclusion criteria: * Forms of psoriasis other than chronic plaque type psoriasis. * Prior exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor. * Chest X-ray with evidence of ongoing infectious or malignant process. * Pregnant or lactating women. * Women of child-bearing potential using inadequate contraception. * Active systemic infections during the last two weeks and/or history of chronic or recurrent infectious disease or evidence of tuberculosis infection. * Plans for administration of live vaccines during the study period or 6 weeks prior to randomization.

Design outcomes

Primary

Measure	Time frame
ppIGA at week 16.	—

Secondary

Measure	Time frame
ppIGA, ppPASI up to week 132, adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)