First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks

NCT01555125 | Completed Phase 3 Results DMC

• 2 other identifiers: CAIN457A23082011-006057-28
• Study Type: interventional
• Target: 177
• Locations: 5 countries
• Sites: 33

Brief Summary

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Conditions

Moderate to Severe Plaque-type Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.

  A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis

  12 weeks

• Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12

  The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe

  12 weeks

Secondary Outcomes (21)

• Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12

  Week 12

• Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48

  Baseline, week 48

• Number of Subjects With Potential Use Related Hazards at Week 1

  Week 1

• Percentage of Subjects With Successful Self Administration of Study Drug at Week 1

  Week 1

• Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation

  Week 12

Study Arms (3)

secukinumab 150 mg

EXPERIMENTAL

Drug

Drug: secukinumab 150 mg

secukinumab 300 mg

EXPERIMENTAL

Drug

Drug: secukinumab 300 mg

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

secukinumab 150 mg DRUG

After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period

secukinumab 150 mg

secukinumab 300 mg DRUG

After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period

secukinumab 300 mg

placebo DRUG

Subjects who were on placebo at Week 52 cannot continue in the extension treatment period

placebo

Eligibility Criteria

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

You may qualify if:

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
• Severity of psoriasis disease meeting all of the following three criteria:
• Psoriasis Area and Severity Index (PASI) score of 12 or greater, Investigator's Global Assessment (IGA) score of 3 or greater, Total body surface area (BSA) affected of 10% or greater.
• Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

You may not qualify if:

• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
• Hematological abnormalities.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (33)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

Location

Novartis Investigative Site

Mobile, Alabama, 36608, United States

Location

Novartis Investigative Site

Glendale, Arizona, 85308, United States

Location

Novartis Investigative Site

Hot Springs, Arkansas, 71913, United States

Location

Novartis Investigative Site

Los Angeles, California, 90045, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30342, United States

Location

Novartis Investigative Site

Newnan, Georgia, 30263, United States

Location

Novartis Investigative Site

Skokie, Illinois, 60077, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02111, United States

Location

Novartis Investigative Site

Fridley, Minnesota, 55432, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 68131, United States

Location

Novartis Investigative Site

Lake Oswego, Oregon, 97035, United States

Location

Novartis Investigative Site

Portland, Oregon, 97223, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29407, United States

Location

Novartis Investigative Site

Goodlettsville, Tennessee, 37072-2301, United States

Location

Novartis Investigative Site

Austin, Texas, 78759, United States

Location

Novartis Investigative Site

Bryan, Texas, 77802, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 1V6, Canada

Location

Novartis Investigative Site

North Bay, Ontario, P1B 3Z7, Canada

Location

Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Novartis Investigative Site

Québec, G1V 4X7, Canada

Location

Novartis Investigative Site

Tallinn, 13419, Estonia

Location

Novartis Investigative Site

Tartu, 51014, Estonia

Location

Novartis Investigative Site

Martigues, 13500, France

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Rouen, 76031, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

Location

Novartis Investigative Site

Gera, 07548, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Related Publications (5)

• Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.

  PMID: 37341961 DERIVED

• Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

  PMID: 35305260 DERIVED

• Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

  PMID: 34110605 DERIVED

• Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.

  PMID: 27576559 DERIVED

• Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.

  PMID: 27573260 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Since most patients were discontinued from study once secukinumab was commercially available in the respective countries, results beyond week 172 cannot be interpreted meaningfully.

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceutical

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: May 8, 2012
• Primary Completion: October 24, 2016
• Study Completion: October 24, 2016
• Last Updated: August 8, 2018
• Results First Posted: August 8, 2018

Record last verified: 2018-08

Locations

CA (4); ES (2); FR (4); DE (5); US (18)