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

NCT03589885 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CAIN457A2325
• Study Type: interventional
• Target: 122
• Locations: 6 countries
• Sites: 22

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

Conditions

Plaque Psoriasis

Keywords

Plaque psoriasis, auto-injector, 2 mL injection, secukinumab

Outcome Measures

Primary Outcomes (2)

• PASI 75 Response After 12 Weeks of Treatment

  Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).

  12 weeks

• IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment

  Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).

  12 weeks

Secondary Outcomes (4)

• PASI 90 Response

  12 weeks

• PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response

  52 weeks

• Successful Self-injection

  From randomization until Week 28

• Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)

  Change from Baseline up to 52 weeks

Study Arms (4)

Placebo 2 mL auto-injector

PLACEBO COMPARATOR

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

Drug: Placebo 2 mL auto-injector

Placebo 1 mL prefilled syringe

PLACEBO COMPARATOR

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

Drug: Placebo 1 mL prefilled syringe

Secukinumab 2 mL auto-injector

EXPERIMENTAL

Secukinumab 300 mg provided in 2 mL auto-injector form

Drug: Secukinumab 2 mL auto-injector

Secukinumab 1 mL prefilled syringe

ACTIVE COMPARATOR

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

Drug: Secukinumab 1 mL prefilled syringe

Interventions

Placebo 2 mL auto-injector 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

Also known as: Placebo

Placebo 2 mL auto-injector

Placebo 1 mL prefilled syringe 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

Also known as: Placebo

Placebo 1 mL prefilled syringe

Secukinumab 2 mL auto-injector 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 2 mL auto-injector

Secukinumab 1 mL prefilled syringe 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

Secukinumab 1 mL prefilled syringe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or Women of at least 18 years of age at time of Screening
• 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.
• Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
• 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.
• 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

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization.
• 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.
• Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
• 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.
• 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.
• 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).
• History of hypersensitivity to any of study drug constituent

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (22)

Novartis Investigative Site

Miami, Florida, 33155, United States

Location

Novartis Investigative Site

Marietta, Georgia, 30060, United States

Location

Novartis Investigative Site

Saint Joseph, Missouri, 64506, United States

Location

Novartis Investigative Site

Verona, New Jersey, 07044, United States

Location

Novartis Investigative Site

Portland, Oregon, 97210, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78218, United States

Location

Novartis Investigative Site

Sugar Land, Texas, 77479, United States

Location

Novartis Investigative Site

Edmonton, Alberta, T5K 1X3, Canada

Location

Novartis Investigative Site

Surrey, British Columbia, V3R 6A7, Canada

Location

Novartis Investigative Site

Bielefeld, 33647, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Vechta, 49377, Germany

Location

Novartis Investigative Site

Witten, 58453, Germany

Location

Novartis Investigative Site

Kopavogur, 201, Iceland

Location

Novartis Investigative Site

Warsaw, Mazowian, 02 495, Poland

Location

Novartis Investigative Site

Wroclaw, 50-566, Poland

Location

Novartis Investigative Site

Alicante, Valencia, 03010, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46014, Spain

Location

Novartis Investigative Site

Barcelona, 08003, Spain

Location

Novartis Investigative Site

Madrid, 28031, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Interventions

secukinumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase IIIb 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 18, 2018
• Study Start: December 19, 2018
• Primary Completion: November 19, 2019
• Study Completion: August 5, 2020
• Last Updated: October 11, 2021
• Results First Posted: August 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (4); ES (5); CA (2); US (8); IC (1); PL (2)