Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

NCT01412944 | Completed Phase 3 Results

• 2 other identifiers: CAIN457A23072011-002510-36
• Study Type: interventional
• Target: 43
• Locations: 8 countries
• Sites: 27

Brief Summary

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

Conditions

Plaque-type Psoriasis

Keywords

Psoriasis; plaque; inflammatory skin disease; scaly patches; AIN457; secukinumab; Moderate to severe

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI

  PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

  Week 8

• Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response

  The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.

  Week 8

Secondary Outcomes (8)

• Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response

  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40

• Mean Percent Change From Baseline in PASI Scores

  Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40

• Percentage of Participants in Each IGA Mod 2011 Score Category

  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40

• Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1

  Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40

• Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores

  Baseline, weeks 8, 16, 24, 32 and 40

Study Arms (2)

AIN457 subcutaneous (s.c.)

EXPERIMENTAL

During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Drug: secukinumab 150mg

AIN457 I.V.

EXPERIMENTAL

During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Drug: secukinumab 10mg/kg i.v. regimen

Interventions

secukinumab 150mg DRUG

secukinumab 150mg (2 injections per dose)

AIN457 subcutaneous (s.c.)

secukinumab 10mg/kg i.v. regimen DRUG

secukinumab 10mg/kg i.v. regimen

AIN457 I.V.

Eligibility Criteria

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

You may qualify if:

• Written Informed Consent must be obtained before any assessment is performed,
• Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
• Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
• A partial response is defined as having achieved ≥ PASI 50 but \< 75 response.

You may not qualify if:

• Pregnant women or lactating women
• Forms of psoriasis other than chronic plaque -type
• Ongoing use of prohibited psoriasis treatments
• Ongoing use of other non-psoriasis prohibited treatments
• Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
• Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
• UV therapy or excessive exposure to sunlight

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (27)

Novartis Investigative Site

Jacksonville, Florida, 32216, United States

Location

Novartis Investigative Site

West Palm Beach, Florida, 33409, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02111, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63117, United States

Location

Novartis Investigative Site

Greensboro, North Carolina, 27401, United States

Location

Novartis Investigative Site

Greer, South Carolina, 29651, United States

Location

Novartis Investigative Site

Wels, Austria, 4600, Austria

Location

Novartis Investigative Site

Graz, A-8036, Austria

Location

Novartis Investigative Site

Vienna, A-1220, Austria

Location

Novartis Investigative Site

Barrie, Ontario, L4M 6L2, Canada

Location

Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2K 4L5, Canada

Location

Novartis Investigative Site

Toulouse, France, 31059, France

Location

Novartis Investigative Site

Rouen, 76031, France

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Hamburg, 22143, Germany

Location

Novartis Investigative Site

Lübeck, 23538, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Mangalore, Karnataka, 575 004, India

Location

Novartis Investigative Site

Nagpur, Maharashtra, 440 010, India

Location

Novartis Investigative Site

Nashik, Maharashtra, 422 001, India

Location

Novartis Investigative Site

Kisarazu, Chiba, 292-8535, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 193-0998, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 105-8471, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Novartis Investigative Site

Košice, Slovak Republic, 040 15, Slovakia

Location

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid; Dermatitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 9, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 18, 2015
• Results First Posted: March 18, 2015

Record last verified: 2015-03

Locations

SL (1); US (6); JP (4); CA (3); AU (3); FR (2); DE (5); IN (3)