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

• ClinicalTrials.gov Identifier: NCT00805480
• Recruitment Status: Completed
• First Posted: December 9, 2008
• Results First Posted: February 10, 2015
• Last Update Posted: February 10, 2015
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Plaque Psoriasis	Drug: AIN457; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients With Chronic Plaque-type Psoriasis.
• Study Start Date: December 2008
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: AIN457 3 mg/kg; Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.	Drug: AIN457; AIN457 was administered intravenously.; Other Name: Secukinumab; Drug: Placebo; Matching placebo to AIN457 was administered intravenously.
Experimental: AIN457 10 mg/kg; Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.	Drug: AIN457; AIN457 was administered intravenously.; Other Name: Secukinumab; Drug: Placebo; Matching placebo to AIN457 was administered intravenously.
Experimental: AIN457 10 mg/kg x3; Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.	Drug: AIN457; AIN457 was administered intravenously.; Other Name: Secukinumab
Placebo Comparator: Placebo; Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29	Drug: Placebo; Matching placebo to AIN457 was administered intravenously.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: Baseline, Week 12 ]
   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).
2. Percentage of Participants Who Had Not Relapsed at Any Time in the Trial [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56 ]
   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.

Secondary Outcome Measures :

1. Percentage of Participants With at Least 50% Improvement From Baseline in PASI [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56) ]
   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).
2. Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56) ]
   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).
3. Percentage of Participants in Each Investigator Global Assessment (IGA) Category [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56) ]
   The IGA 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, 4 = severe and 5 = very severe.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:

  1. Coverage of the body surface area (BSA) of 10% or more with plaques
  2. A score of 3 or more on the IGA scale

  3. A PASI score of at least 12 at baseline

     Exclusion Criteria:

• 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;

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals
• Principal Investigator: Novartis; Novartis Investigator Site

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00805480
• Other Study ID Numbers: CAIN457A2212
• First Posted: December 9, 2008
• Results First Posted: February 10, 2015
• Last Update Posted: February 10, 2015
• Last Verified: January 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

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

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases