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

Novartis

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Chronic Plaque-Type Psoriasis

Treatments: Drug: Placebo; Drug: AIN457 300 mg; Drug: AIN457 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01640951

CAIN457A2304E1

2012-000985-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 675 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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675 participants in 5 patient groups

AIN457 150 mg - Fixed Interval (FI)

Experimental group

Description:

1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks

Treatment:

Drug: AIN457 150 mg

Drug: Placebo

AIN457 150 mg - Start of relapse (SoR)

Experimental group

Description:

Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Treatment:

Drug: AIN457 150 mg

Drug: Placebo

AIN457 300 mg - Fixed Interval (FI)

Experimental group

Description:

2 s.c. Secukinumab 150 mg PFS injections every 4 weeks

Treatment:

Drug: AIN457 300 mg

AIN457 300 mg - Start of Relapse (SoR)

Experimental group

Description:

Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Treatment:

Drug: Placebo

Drug: AIN457 300 mg

AIN457 300 mg - Open Label (OL)

Experimental group

Description:

Open Label - Secukinumab 300mg every 4 weeks

Treatment:

Drug: AIN457 300 mg