Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

Demonstrate superiority of secukinumab high dose over standard dose in heavy body weight subjects with moderate to severe plaque psoriasis.

Official Title

A Randomized, Double-blind, Multicenter Study Assessing Short and Long-term Efficacy, Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis

Details

A 52-week multicenter, randomized, double-blind, parallel-group trial in approximately 330 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization.

The study consists of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks), treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).

Subjects will be randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg every 2 weeks; Secukinumab 300 mg every 4 weeks.

In addition, subjects from the 300 mg every 4 weeks group who do not achieve PASI 90 response at Week 16 will be randomized using a 1:1 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of treatment.

Keywords

Moderate to Severe Chronic Plaque-type Psoriasis psoriasis secukinumab immune-mediated systemic disease papules plaques itching secukinumab 150 mg Secukinumab 300 mg every 2 weeks Secukinumab 300 mg every 4 weeks

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Written informed consent must be obtained before any assessment is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
  2. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study.
  3. Men or women at least 18 years of age at time of screening.
  4. Body weight of ≥ 90 kg at the time of randomization.
  5. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
  6. Moderate to severe psoriasis as defined at randomization by:
  7. Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
  8. IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
  9. Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
  10. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:
  11. topical treatment and/or,
  12. phototherapy and/or,
  13. previous systemic therapy.

You CAN'T join if...

  1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.
  2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
  3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin-17 (IL-17) or the IL-17 receptor.
  4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
  5. Pregnant or nursing (lactating) women
  6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
  7. History of hypersensitivity to any of the study drug constituents.

Locations

  • Novartis Investigative Site
    Sacramento California 95817 United States
  • Novartis Investigative Site
    Sacramento California 95819 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
Links
Sign up for this study
ID
NCT03504852
Phase
Phase 3
Study Type
Interventional
Last Updated