A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis

NCT00669916 | Completed Phase 1 Results

• 1 other identifier: CAIN457A2102
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or placebo will be administered by single infusion at baseline and subjects will be observed for up to 26 weeks following the infusion.

Conditions

Plaque Psoriasis

Keywords

Plaque psoriasis

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score

  The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement.

  Baseline, Week 4

• Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score

  The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease. The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline. The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease. This outcome measure shows the percentage of patients who experienced a category change from baseline. Category changes of 1, 2 or 3 indicate improvement.

  Baseline, Week 4

Secondary Outcomes (6)

• Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)

  Day 182

• Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)

  Day 182

• Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)

  Day 182

• Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)

  Day 182

• Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)

  Day 182

Study Arms (2)

AIN457

EXPERIMENTAL

AIN457A 3mg/kg was administered intravenously as a single dose.

Biological: AIN457

Placebo

PLACEBO COMPARATOR

Placebo was administered intravenously as a single dose.

Drug: Placebo

Interventions

AIN457 BIOLOGICAL

single infusion of 3 mg/kg

AIN457

Placebo DRUG

single infusion of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, aged 18-69 at time of consent.
• Post menopausal or surgically sterile female patients are allowed. Male patients must be willing to use contraception method at least for 3 months following the completion of the study. Women of child-bearing potential will not be allowed to participate.
• Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet both 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
• Stable plaque psoriasis at screening and randomization.
• PASI score of 12 or greater at randomization.
• Able to communicate well with the investigator, and to understand and comply with the requirements of the study. Understand and sign the written informed consent.
• Patients must have normal laboratory values for screening laboratory test results of hematological (hemoglobin, WBCs, neutrophils, platelets) and renal (serum creatinine) assessments. For the transaminases, aspartate aminotransferase and alanine aminotransferase, levels 1.5 times the upper limit of normal will be accepted. For the additional hepatic laboratory results (alkaline phosphatase, gamma-glutamyltransferase, bilirubin), patients must have non-clinically significant values.

You may not qualify if:

• Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
• Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
• Men who are planning to initiate a pregnancy while enrolled in the study or for 3 months following completion of the study.
• Women of child-bearing potential are not allowed in the study.
• Used any investigational drug within the previous 4 weeks.
• Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial.
• months washout prior to screening for etanercept, adalimumab, or infliximab.
• month washout prior to screening for cyclosporine, mycophenolate, tacrolimus, and any systemic immunosuppressants including, but not limited to, methotrexate, azathioprine, 6-thioguanine, mercaptopurine, and hydroxyurea

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Related Publications (1)

• Hueber W, Patel DD, Dryja T, Wright AM, Koroleva I, Bruin G, Antoni C, Draelos Z, Gold MH; Psoriasis Study Group; Durez P, Tak PP, Gomez-Reino JJ; Rheumatoid Arthritis Study Group; Foster CS, Kim RY, Samson CM, Falk NS, Chu DS, Callanan D, Nguyen QD; Uveitis Study Group; Rose K, Haider A, Di Padova F. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med. 2010 Oct 6;2(52):52ra72. doi: 10.1126/scitranslmed.3001107.

  PMID: 20926833 DERIVED

MeSH Terms

Interventions

secukinumab

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: February 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 10, 2015
• Results First Posted: April 10, 2015

Record last verified: 2015-04