Clinical trial NCT01544595: Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
Official title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Plaque-type Psoriasis
Keywords: Psoriasis, inflammatory skin disease
scaly patches
secukinumab (AIN457)
Psoriasis Area and Severity Index (PASI)
Investigator Global Assessment (IGA) mod 2011
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 1147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.


Eligibility criteria: Key Inclusion Criteria:

Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.

Written informed consent form.

Key Exclusion Criteria:

A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.

Ongoing use of prohibited psoriasis or non-psoriasis treatments.

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).

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.

Primary outcomes:
measure: Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68
timeFrame: At week 68 (16 weeks after week 52)
Secondary outcomes:
measure: Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period
timeFrame: Week 52, 104, and 156
measure: Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period
timeFrame: Week 52, Week 104, Week 156, week 208, week 260
measure: Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period
timeFrame: Week 52, 104, and 156
measure: Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period
timeFrame: Week 52, Week 104, Week 156, week 208, week 260
measure: Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period
timeFrame: Week 52 (baseline), 104, and 156
measure: Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period
timeFrame: Week 52, Week 104, Week 156, week 208, week 260
measure: Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period
timeFrame: Week 52, Week 104, Week 156, week 208, week 260
measure: Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period
timeFrame: Week 68
measure: Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse
timeFrame: up to week 260
measure: Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse
timeFrame: up to week 260
measure: Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period
timeFrame: up to week 156
measure: Percent of Participants With Relapse After Last Injection
timeFrame: up to week 16
measure: Percent of Participants With Rebound After Last Injection
timeFrame: up to week 68
measure: Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)
timeFrame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
measure: Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period
timeFrame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
measure: EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period
timeFrame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
measure: EQ-5D Health State Assessment (Observed Value) - Entire Study Period
timeFrame: week 64, 76, 88, 104, 116, 128, 140, and 156
measure: Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period
timeFrame: Week 52-156
measure: Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period
timeFrame: approximately 4 years
measure: Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period
timeFrame: Week 52 - 156
measure: Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period
timeFrame: Approximately 4 years
Other outcomes:
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city: Halifax
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city: Hamilton
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state: Ontario
city: Markham
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state: Ontario
city: Peterborough
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state: Ontario
city: Richmond Hil
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state: Ontario
city: Waterloo
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city: Montreal
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state: Quebec
city: Sainte-Foy
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state: Quebec
city: Barranquilla
country: Colombia
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state: Atlantico
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city: Bogota
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city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
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city: Helsinki
country: Finland
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city: Paris Cedex 10
country: France
facility: Novartis Investigative Site
state: Cedex 10
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Marseille Cedex 9
country: France
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city: Toulouse Cedex
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city: Koeln
country: Germany
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state: Nordrhein-Westfalen
city: Augsburg
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city: Berlin
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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state: Tokyo
city: Shinjuku-ku
country: Japan
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city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho-gu
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Ventspils
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santa Coloma De Gramanet
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Malmo
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Hsin Chu
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
state: Devon
city: London
country: United Kingdom
facility: Novartis Investigative Site
state: England
city: Salford
country: United Kingdom
facility: Novartis Investigative Site
state: Manchester
city: Yeovil
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: Dudley
country: United Kingdom
facility: Novartis Investigative Site
state: West Midlands
city: Harrogate
country: United Kingdom
facility: Novartis Investigative Site
city: Nuneaton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: