4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Moderate to Severe Chronic Plaque-Type Psoriasis Clinical Trial

Official title:

A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640951
• Other study ID #: CAIN457A2304E1
• Secondary ID: 2012-000985-39
• Status: Completed
• Phase: Phase 3
• Start date: September 16, 2012
• Est. completion date: May 4, 2017

Study information

• Verified date: April 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 675
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations.

2. Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307

3. Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator

Exclusion Criteria:

1. A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject

2. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study.

3. Subjects expected to be exposed to an undue safety risk if participating in the trial

4. Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial

5. Plans for administration of live vaccines during the study period

6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL).

Related Conditions & MeSH terms

• Moderate to Severe Chronic Plaque-Type Psoriasis
• Psoriasis

Intervention

Drug:
• AIN457 150 mg
(1 injection per dose) and placebo to Secukinumab 150 mg
• AIN457 300 mg
Secukinumab 150 mg (2 injections per dose)
• Placebo

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Wels
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Varna
Canada	Novartis Investigative Site	Barrie	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Oakville	Ontario
Canada	Novartis Investigative Site	Waterloo	Ontario
Canada	Novartis Investigative Site	Windsor	Ontario
Czechia	Novartis Investigative Site	Brno - Bohunice	Czech Republic
Czechia	Novartis Investigative Site	Ceske Budejovice
Czechia	Novartis Investigative Site	Hradec Kralove	CZE
Czechia	Novartis Investigative Site	Novy Jicin
Czechia	Novartis Investigative Site	Prague 10
Czechia	Novartis Investigative Site	Prague 8	CZE
France	Novartis Investigative Site	Antony
France	Novartis Investigative Site	Nice Cedex 3
France	Novartis Investigative Site	Pierre-Benite Cedex
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Toulouse Cedex
Germany	Novartis Investigative Site	Bad Wildbad
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Buchholz I. D. Nordheide
Germany	Novartis Investigative Site	Dippoldiswalde-Schmiedeberg
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Duisburg
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koeln	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Luebeck
Germany	Novartis Investigative Site	Mahlow
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Wuppertal
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Verona	VR
Japan	Novartis Investigative Site	Asahikawa-city	Hokkaido
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kisarazu	Chiba
Japan	Novartis Investigative Site	Kitakyushu-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	Osaka-city	Osaka
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Shimotsuke-city	Tochigi
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Wroclaw
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Poprad
Slovakia	Novartis Investigative Site	Svidnik
Slovakia	Novartis Investigative Site	Zilina
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Zuerich
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Blackpool
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	Leytonstone	London
United Kingdom	Novartis Investigative Site	Poole
United States	Novartis Investigative Site	Anderson	South Carolina
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Champaign	Illinois
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Fridley	Minnesota
United States	Novartis Investigative Site	Goodlettsville	Tennessee
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greer	South Carolina
United States	Novartis Investigative Site	Henderson	Nevada
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Pasadena	California
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Francisco	California
United States	Novartis Investigative Site	Skokie	Illinois
United States	Novartis Investigative Site	South Miami	Florida
United States	Novartis Investigative Site	Verona	New Jersey
United States	Novartis Investigative Site	West Palm Beach	Florida
United States	Novartis Investigative Site	Winston-Salem	North Carolina
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh
Vietnam	Novartis Investigative Site	Ho Chi Minh	VNM

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Austria,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Italy,  Japan,  Poland,  Singapore,  Slovakia,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term Safety and Tolerability of Secukinumab	Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)	Week 268
Secondary	Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260	PASI: 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 52, Week 104, Week 156, Week 208, Week 260
Secondary	Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260	PASI: 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 52, Week 104, Week 156, Week 208, Week 260
Secondary	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260	PASI: 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)	Baseline, Week 52, Week 104, Week 156, Week 208, Week 260
Secondary	Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260	The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe.	Week 52, Week 104, Week 156, Week 208, Week 260
Secondary	Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions	Baseline, Week 52, Week 104, Week 156, Week 208, Week 260
Secondary	Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions	Week 52, Week 104, Week 156, Week 208, Week 260
Secondary	EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156	ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)	Baseline, Week 52, Week 104, Week 156
Secondary	Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)	The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.	Week 268
Secondary	Percentage of Patients With Experiencing a Relapse	Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline.; 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). A negative mean percentage change indicates improvement.	Week 260
Secondary	Percentage of Patients With Experiencing a Rebound	Rebound of disease is defined as a worsening of PASI of > 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event).; 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). A negative mean percentage change indicates improvement.	Up to Week 264 (8 weeks post last dose)