AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis

Plaque-type Psoriasis Clinical Trial

Official title:

A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132612
• Other study ID #: CAIN457A2211E1
• Secondary ID: 2009-017234-51
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2010
• Last updated: December 8, 2017
• Start date: May 11, 2010
• Est. completion date: October 18, 2016

Study information

• Verified date: December 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

Description:

In the Proof-of-Concept study (CAIN457A2102/ NCT00669916), AIN457 was proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study had been started (CAIN457A2211/NCT00941031).

The data gathered in this extension study of the core study (CAIN457A2211)was used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The participants in the extension study continued to stay on the exact same treatment regimen they were taking when completing the core study. The extension trial was first designed to provide long-term safety data of up to 100 weeks of treatment (32 weeks in the core study plus 68 weeks in the extension study (part 1)), and an additional 12 weeks of treatment-free follow-up for participants who did not continue in the extension study. Amendment 2 provided an additional 156 weeks of treatment (32 weeks in the core study plus 224 weeks in the extension study, equaling 256 weeks of total treatment (part 2)), before participants entered the 12 weeks of treatment-free follow-up. Protocol Amendment 3 extended the prolongation part of the study by up to 104 additional weeks of treatment (part 3) or until the drug was commercially available in the market of the country of participation, whichever occurred first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: October 18, 2016
• Est. primary completion date: October 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4) of the core study

• Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed.

• Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator

• Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration Note: Due to new data available from the toxicology studies, the need for male contraception was removed.

Key Exclusion Criteria:

• Patients who experience a second consecutive full relapse at visit 13 ( week F4) of the core study CAIN457A2211

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (> 5mlU/mL)

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.

Related Conditions & MeSH terms

• Plaque-type Psoriasis
• Psoriasis

Intervention

Drug:
• AIN457
AIN457A 150 mg powder for solution
• Placebo
Placebo to AIN457A 150 mg powder for solution

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	Gottingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Kiel
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-city	Fukuoka
Japan	Novartis Investigative Site	Kurume city	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	Champaign	Illinois
United States	Novartis Investigative Site	Charlottesville	Virginia
United States	Novartis Investigative Site	Clinton Township	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	Minneapolis	Minnesota
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	Portland	Oregon
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Saint Louis	Missouri
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	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	Number of Participants With Adverse Events, Serious Adverse Events and Deaths	Safety was assessed by frequency of adverse events including serious adverse events.	up to week 351
Secondary	Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response	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). The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.	Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)
Secondary	Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial	Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment.	up to week 351