A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01071252
First received: February 18, 2010
Last updated: February 12, 2015
Last verified: February 2015

February 18, 2010
February 12, 2015
March 2010
February 2011   (final data collection date for primary outcome measure)
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 [ Time Frame: week 13 ] [ Designated as safety issue: No ]
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).
Efficacy of 3 different doses of AIN457 s.c. administered monthly (25 mg, 75 mg and 150 mg) or as a single administration (25 mg) in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement, compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01071252 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Investigator's Global Assessment (IGA) Response [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ] [ Designated as safety issue: No ]
    IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
  • Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ] [ Designated as safety issue: No ]
    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).
  • To Assess the Time to Relapse [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
    Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.
  • To evaluate treatment success as assessed by the Investigator's Global Assessment (static IGA) 12 weeks after start of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of the three different doses administered monthly as well as the single dosing at 12 weeks after start of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess the time to relapse [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
  • To measure the effect of AIN457 on PASI over time [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
  • To investigate the safety and tolerability [ Time Frame: 37 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
A Randomized, Double-blind, Placebo Controlled, Multicenter Dose Ranging Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Plaque-type Psoriasis
  • Drug: AIN457
  • Drug: Placebo
  • Experimental: AIN457 1x25mg
    Intervention: Drug: AIN457
  • Experimental: AIN457 3x25mg
    Intervention: Drug: AIN457
  • Experimental: AIN457 3x75mg
    Intervention: Drug: AIN457
  • Experimental: AIN457 3x150mg
    Intervention: Drug: AIN457
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

At randomization, moderate to severe psoriasis as defined by:

  • PASI score of 12 or greater and,
  • IGA score of 3 or greater and,
  • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque-type
  • Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
  • Previous exposure to AIN457
  • Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
  • Known immunosuppression (e.g., AIDS) at screening and / or randomization
  • History or evidence of active tuberculosis at screening
  • Active systemic infections (other than common cold)
  • History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
  • Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
  • Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
  • Inability or unwillingness to undergo repeated venipuntures
  • History or evidence of drug or alcohol abuse
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Estonia,   Iceland,   Japan,   Latvia
 
NCT01071252
CAIN457A2220, 2009-016807-42
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP