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Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

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ClinicalTrials.gov Identifier: NCT03066609
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Secukinumab 150 mg s.c. Drug: Secukinumab 300 mg s.c. Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Twelve Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis With or Without Psoriatic Arthritis Comorbidity
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab 150mg
Secukinumab 150mg s.c.
Drug: Secukinumab 150 mg s.c.
150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48

Experimental: Secukinumab 300mg
Secukinumab 300mg s.c.
Drug: Secukinumab 300 mg s.c.
300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48

Placebo Comparator: Placebo
Placebo to secukinumab s.c
Drug: Placebo
Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48




Primary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) 75 [ Time Frame: Week 12 ]
    Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard.

  2. Investigator`s Global Assessment (IGA) mod 2011 0/1 [ Time Frame: Week 12 ]
    Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease).


Secondary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline to Week 52 ]
    Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard

  2. Investigator's Global Assessment (IGA) mod 2011 0/1 [ Time Frame: Baseline to Week 52 ]
    Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease).

  3. American Collage of Rheumatology (ACR) Response 20/50/70 [ Time Frame: Baseline to Week 52 ]
    Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must give a written, signed and dated informed consent.
  2. Men or women at least 18 years of age at time of screening.
  3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
  4. Moderate to severe psoriasis as defined at Baseline by:

    • PASI score of 12 or greater, and
    • IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
    • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
  5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

    • topical treatment and/or,
    • phototherapy and/or,
    • previous systemic therapy.

Exclusion Criteria:

  1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
  2. Drug-induced psoriasis.
  3. Ongoing use of prohibited treatments.
  4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
  5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066609


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Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03066609     History of Changes
Other Study ID Numbers: CAIN457A2318
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Plaque psoriasis
psoriasis vulgaris
psoriasis
Secukinumab
Skin condition
skin disease
itching
immune-mediated systemic disease
skin lesions
scaly patches
papules
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs