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Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01544595
First received: February 28, 2012
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

This is 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) will be eligible to join this extension study. This extension study is 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 will be used.


Condition Intervention Phase
Moderate to Severe Plaque-type Psoriasis
Drug: Secukinumab (AIN457)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 2 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Cumulative rate of subjects with Loss of Psoriasis Area and Severity Index (PASI) 75 response up to Week 68 [ Time Frame: At week 68; 16 weeks after week 52 ] [ Designated as safety issue: No ]
    Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis


Secondary Outcome Measures:
  • Change in Psoriasis Area and Severity Index (PASI) [ Time Frame: Measured throughout the study (for 104 weeks; Week 52 to Week 156) i.e. at Week 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, 152 and 156 ] [ Designated as safety issue: No ]
  • Investigator Global Assessment (IGA) 2011 score [ Time Frame: Measured throughout the study (for 104 weeks; Week 52 to Week 156) i.e. at Week 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, 152 and 156 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index (PASI) 75 response, and [ Time Frame: Measured throughout the study (for 104 weeks; Week 52 to Week 156) i.e. at Week 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, 152 and 156 ] [ Designated as safety issue: No ]
  • Hemoglobin count, hematocrit count, red blood cell count, white blood cell count with differential(neutrophils including bands, lymphocytes, monocytes, eosinophils, basophils) and platelet count [ Time Frame: Week 52, 64, 76, 88, 104, 116, 128, 140, 156 ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) test results [ Time Frame: Week 52, 64, 76, 88, 104, 116, 128, 140, 156 ] [ Designated as safety issue: No ]
    measured in degrees

  • Adverse events [ Time Frame: Measured throughout the study (for 104 weeks; Week 52 to Week 156) i.e. at Week 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, 152 and 156 ] [ Designated as safety issue: Yes ]
    percentage of patients with any adverse events

  • Change in quality of life [ Time Frame: Weeks 52, 64, 76, 88, 104, 116, 128, 140, 156 ] [ Designated as safety issue: No ]
    Change in EQ-5D©, DLQI© and HAQ©-DI scores


Enrollment: 1152
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PASI 75 Responders
PASI 75 responders will participate in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies will be randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Randomization in each group will be 2:1. Participants on first full relapse will receive loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen.
Drug: Secukinumab (AIN457)
Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.
Drug: Placebo
Placebo
Experimental: Partial responders
Partial responders are not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies do not participate in the randomized withdrawal. These subjects will continue same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies
Drug: Secukinumab (AIN457)
Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion criteria:

A protocol deviation in either of the preceding phase III studies which according to the investigator will prevent 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.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544595

  Show 182 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01544595     History of Changes
Other Study ID Numbers: CAIN457A2302E1, 2012-000533-39
Study First Received: February 28, 2012
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Psoriasis, inflammatory skin disease
scaly patches
secukinumab (AIN457)
Psoriasis Area and Severity Index (PASI)
Investigator Global Assessment (IGA) mod 2011

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014