NCT00770965

Brief Summary

This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

September 10, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2009

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

February 18, 2015

Completed
Last Updated

March 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

October 9, 2008

Results QC Date

February 2, 2015

Last Update Submit

February 12, 2018

Conditions

Chronic Plaque Psoriasis

Keywords

Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease

Outcome Measures

Primary Outcomes (1)

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

    This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.

    baseline, week 4

Secondary Outcomes (2)

  • Change From Baseline in PASI

    baseline, weeks 12, 14, 16, 20, 24, 28 and 32

  • Investigator Global Assessment (IGA) Scores

    baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32

Study Arms (4)

AIN457 0.3 mg/kg

EXPERIMENTAL

Participants received AIN457 0.3 mg/kg IV on Day 1.

Biological: AIN457

AIN457 1.0 mg/kg

EXPERIMENTAL

Participants received AIN457 1.0 mg/kg IV on Day 1.

Biological: AIN457

AIN457 3.0 mg/kg

EXPERIMENTAL

Participants received AIN457 3.0 mg/kg IV on Day 1.

Biological: AIN457

Placebo

PLACEBO COMPARATOR

Participants received placebo to AIN457A IV on day 1.

Biological: Placebo

Interventions

AIN457BIOLOGICAL
AIN457 0.3 mg/kgAIN457 1.0 mg/kgAIN457 3.0 mg/kg
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 (Investigator Global Assessment) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Santa Monica, California, 90404, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40217, United States

Location

Novartis Investigative Site

High Point, North Carolina, 27262, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16634, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Skin DiseasesAutoimmune Diseases

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesImmune System Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    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

October 9, 2008

First Posted

October 10, 2008

Study Start

September 10, 2008

Primary Completion

September 17, 2009

Study Completion

September 17, 2009

Last Updated

March 12, 2018

Results First Posted

February 18, 2015

Record last verified: 2018-02

Locations

US(5)