Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

NCT00805480 | Completed Phase 2 Results

• 1 other identifier: CAIN457A2212
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.

Conditions

Chronic Plaque Psoriasis

Keywords

Plaque; psoriasis; inflammatory skin disease; skin condition, thickening; flaking; scaly patches; skin disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores

  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).

  Baseline, Week 12

• Percentage of Participants Who Had Not Relapsed at Any Time in the Trial

  This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.

  Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56

Secondary Outcomes (3)

• Percentage of Participants With at Least 50% Improvement From Baseline in PASI

  Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)

• Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI

  Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)

• Percentage of Participants in Each Investigator Global Assessment (IGA) Category

  Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)

Study Arms (4)

AIN457 3 mg/kg

EXPERIMENTAL

Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.

Drug: AIN457; Drug: Placebo

AIN457 10 mg/kg

EXPERIMENTAL

Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.

Drug: AIN457; Drug: Placebo

AIN457 10 mg/kg x3

EXPERIMENTAL

Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.

Drug: AIN457

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29

Drug: Placebo

Interventions

AIN457 DRUG

AIN457 was administered intravenously.

Also known as: Secukinumab

AIN457 10 mg/kg; AIN457 10 mg/kg x3; AIN457 3 mg/kg

Placebo DRUG

Matching placebo to AIN457 was administered intravenously.

AIN457 10 mg/kg; AIN457 3 mg/kg; Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
• Coverage of the body surface area (BSA) of 10% or more with plaques
• A score of 3 or more on the IGA scale
• A PASI score of at least 12 at baseline

You may not qualify if:

• Have forms of psoriasis other than the required "plaque psoriasis"
• Women of childbearing potential
• Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
• Previous treatment with this investigational drug
• Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities;

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Plaque, Amyloid; Psoriasis; Dermatitis; Skin Diseases

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis

  Novartis Investigator Site

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 10, 2015
• Results First Posted: February 10, 2015

Record last verified: 2015-01