NCT01071252

Brief Summary

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2

Geographic Reach
6 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 16, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

11 months

First QC Date

February 18, 2010

Results QC Date

January 28, 2015

Last Update Submit

February 12, 2015

Conditions

Chronic Plaque-type Psoriasis

Keywords

Moderate to severe chronic plaque-type psoriasisAIN457dermatology

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13

    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 13

Secondary Outcomes (3)

  • Percentage of Participants With Investigator's Global Assessment (IGA) Response

    Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37

  • Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)

    Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37

  • To Assess the Time to Relapse

    37 weeks

Study Arms (5)

AIN457 1x25mg

EXPERIMENTAL
Drug: AIN457

AIN457 3x25mg

EXPERIMENTAL
Drug: AIN457

AIN457 3x75mg

EXPERIMENTAL
Drug: AIN457

AIN457 3x150mg

EXPERIMENTAL
Drug: AIN457

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AIN457DRUG
AIN457 1x25mgAIN457 3x150mgAIN457 3x25mgAIN457 3x75mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Novartis Investigative Site

San Diego, California, 92123, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40217, United States

Location

Novartis Investigative Site

Rochester, New York, 14623, United States

Location

Novartis Investigative Site

Lake Oswego, Oregon, 97035, United States

Location

Novartis Investigative Site

Portland, Oregon, 97210, United States

Location

Novartis Investigative Site

Halifax, Nova Scotia, B3H 1Z2, Canada

Location

Novartis Investigative Site

North Bay, Ontario, P1B 3Z7, Canada

Location

Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Novartis Investigative Site

Tallinn, Estonia, 10138, Estonia

Location

Novartis Investigative Site

Tallinn, 13419, Estonia

Location

Novartis Investigative Site

Tartu, 51014, Estonia

Location

Novartis Investigative Site

Kopavogur, IS-201, Iceland

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

Novartis Investigative Site

Maebashi, Gunma, 371-8511, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-0063, Japan

Location

Novartis Investigative Site

Saitama, Saitama, 330-0854, Japan

Location

Novartis Investigative Site

Riga, 1012, Latvia

Location

Novartis Investigative Site

Riga, LV-1001, Latvia

Location

Novartis Investigative Site

Riga, Latvia

Location

Related Links

MeSH Terms

Interventions

secukinumab

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
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 2
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

February 18, 2010

First Posted

February 19, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 16, 2015

Results First Posted

February 16, 2015

Record last verified: 2015-02

Locations

CA(3)LA(3)US(5)JP(4)IC(1)ES(3)