Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis

NCT ID: NCT03589885

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2020-08-05

Brief Summary

The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis

Detailed Description

This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo 2 mL auto-injector

Placebo to secukinumab s.c., provided in 2 mL auto-injector form

Group Type: PLACEBO_COMPARATOR

Placebo 2 mL auto-injector

Intervention Type: DRUG

All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.

PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.

PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Placebo 1 mL prefilled syringe

Placebo to secukinumab s.c., provided in 2 \* 1 ml prefilled syringe form

Group Type: PLACEBO_COMPARATOR

Placebo 1 mL prefilled syringe

Intervention Type: DRUG

All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.

PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.

PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Secukinumab 2 mL auto-injector

Secukinumab 300 mg provided in 2 mL auto-injector form

Group Type: EXPERIMENTAL

Secukinumab 2 mL auto-injector

Intervention Type: DRUG

2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48

Secukinumab 1 mL prefilled syringe

Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Group Type: ACTIVE_COMPARATOR

Secukinumab 1 mL prefilled syringe

Intervention Type: DRUG

2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Interventions

Placebo 2 mL auto-injector

All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.

PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.

PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Intervention Type: DRUG

Placebo 1 mL prefilled syringe

All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.

PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.

PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Intervention Type: DRUG

Secukinumab 2 mL auto-injector

2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48

Intervention Type: DRUG

Secukinumab 1 mL prefilled syringe

2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Intervention Type: DRUG

Other Intervention Names

Placebo; Placebo

Eligibility Criteria

Inclusion Criteria

Subjects eligible for inclusion in this study must have fulfilled all of the following criteria:

1. Men or Women of at least 18 years of age at time of Screening

2. Subjects able to understand and communicate with the investigator and comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. Where relevant, a legal representative signed the informed study consent according to local laws and regulations.

3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.

4. Moderate to severe psoriasis as defined at Randomization by:

• PASI score of 12 or greater, and
• IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and
• Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.

5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

• Topical treatment and/or
• Phototherapy and/or
• Previous systemic therapy

Exclusion Criteria

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 had 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 were considered not eligible for this study since UV light exposure was prohibited.

Note: administration of live vaccines 6 weeks prior to Randomization or during the study period was also prohibited.

3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting 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 30 days until the expected pharmacodynamic effect had returned to baseline, whichever is longer; or longer if required by local regulations.

5. Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

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 was evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that had 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 study drug constituent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Marietta, Georgia, United States

Novartis Investigative Site

Saint Joseph, Missouri, United States

Novartis Investigative Site

Verona, New Jersey, United States

Novartis Investigative Site

Portland, Oregon, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

San Antonio, Texas, United States

Novartis Investigative Site

Sugar Land, Texas, United States

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

Surrey, British Columbia, Canada

Novartis Investigative Site

Bielefeld, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Vechta, , Germany

Novartis Investigative Site

Witten, , Germany

Novartis Investigative Site

Kopavogur, , Iceland

Novartis Investigative Site

Warsaw, Mazowian, Poland

Novartis Investigative Site

Wroclaw, , Poland

Novartis Investigative Site

Alicante, Valencia, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Barcelona, , Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Madrid, , Spain

Countries

United States; Canada; Germany; Iceland; Poland; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=815

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

CAIN457A2325

Identifier Type: -

Identifier Source: org_study_id