AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

Chronic Plaque-type Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941031
• Other study ID #: CAIN457A2211
• Secondary ID: 2008-007525-39
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2009
• Last updated: July 30, 2015
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women at least 18 years of age at time of consent

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

• At time of 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 and/or

• phototherapy and/or

• previous systemic therapy

Exclusion Criteria:

• Patients meeting any of the following criteria will be excluded from entry into the study:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization

• Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization

• Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to

• Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration

• Known immunosuppression (e.g., AIDS) at screening and / or randomization

• History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.

• Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)

• At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases

• History of congestive heart failure (NYHA functional classification =III) at screening and / or randomization

• History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization

• Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study

• Pregnant or nursing (lactating) women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plaque-type Psoriasis
• Psoriasis

Intervention

Drug:
• AIN457

• AIN457A
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
• AIN457A
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
• Placebo
Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9

Locations

Country	Name	City	State
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Toulouse Cedex
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Göttingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Luebeck
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Tuebingen
Iceland	Novartis Investigative Site	Kopavogur
Israel	Novartis Investigative Site	Afula
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Ramat Gan
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chitose	Hokkaido
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kitakyushu	Fukuoka
Japan	Novartis Investigative Site	Kurume	Fukuoka
Japan	Novartis Investigative Site	Maebashi-city	Gunma
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Norway	Novartis Investigative Site	Ålesund
Norway	Novartis Investigative Site	Bergen
Norway	Novartis Investigative Site	Oslo
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Champaign	Illinois
United States	Novartis Investigative Site	Charlottesville	Virginia
United States	Novartis Investigative Site	Clinton Twp.	Michigan
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Henderson	Nevada
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Lake Oswego	Oregon
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Lynchburg	Virginia
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Newnan	Georgia
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Pasadena	California
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Snellville	Georgia
United States	Novartis Investigative Site	Springfield	Illinois
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Topeka	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Iceland,  Israel,  Japan,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.	Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment	13 weeks	No
Secondary	The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29		week 21 to 29	No
Secondary	The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo	The investigator's global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).	13 weeks	No