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Safety and Efficacy of Secukinumab in Mild Psoriasis

  Purpose

Mild psoriasis not only progresses to moderate-to-severe psoriasis but also precedes systemic inflammation that leads to psoriatic arthritis and cardiovascular comorbidities. By curing mild psoriasis with a short-term anti- interleukin (IL)-17A treatment, investigators may reduce the costs of treating psoriasis and associated medical conditions, including psoriatic arthritis, cardiovascular disease, and diabetes.

Condition Intervention Phase
Psoriasis Drug: Secukinumab Drug: Placebo followed by Secukinumab Phase 2

Study Type: Interventional
Study Design:Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

To compare the secukinumab-receiving mild psoriasis subjects (Group 1) and the placebo-receiving mild psoriasis subjects (Group 2).

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Official Title:Safety and Efficacy of Secukinumab in Adults With Chronic Plaque Type Psoriasis With a PASI Score of 6 to 12

Resource links provided by NLM:

Further study details as provided by James G. Krueger, MD, PhD, Rockefeller University:

Primary Outcome Measures:

  • Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) [ Time Frame: week 12 ]
    The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 12.

Secondary Outcome Measures:

  • Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) [ Time Frame: week 12 ]
    The proportion of subjects who have a reduction of 90% or more from baseline in the psoriasis area-and severity index score (PASI 90) at week 12.

  • Proportion of subjects who achieve a score of 0 on a 5-point modified Investigator’s Global Assessment (IGA0) [ Time Frame: week 12 ]
    The proportion of subjects who achieve a score of 0 (clear) on a 5-point modified investigator’s global assessment (IGA) at week 12.

  • Proportion of subjects who experience psoriasis relapse [ Time Frame: week 24 through week 72 ]
    The proportion of subjects who experience a psoriasis relapse at any time between week 24 and week 72. Psoriasis relapse is defined as loss of > 50% of the initial PASI improvement measured at week 24.

  • Severity of relapses [ Time Frame: Observation Period: week 24 through week 72. ]
    Severity of the relapses over the observation period.

  • Extent of relapses measured by the proportion of relapse frequencies between subjects who achieve clearance of psoriasis and subjects who do not achieve clearance of psoriasis. [ Time Frame: Observation Period: week 24 through week 72 ]
    Extent of relapses measured by the proportion of relapse frequencies between subjects who achieve a score of 0 (clear) on IGA (Investigator’s Global Assessment) and subjects who do not achieve a score of 0 (clear) on IGA over the observation period.

  • Elapsed time until relapse [ Time Frame: week 24 until week 72 ]
    Elapsed time from week 24 until relapse occurs before week 72, measured in weeks.

  • Proportion of subjects who have 90% or 100% reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90 or PASI100) [ Time Frame: week 12 ]
    The proportion of subjects who have a reduction of 90% or 100% from baseline in the psoriasis area-and severity index score (PASI90 or PASI100) at week 12.

  • Frequency of Adverse Events and Serious Adverse Events [ Time Frame: week 0 through week 72 ]
    Frequency of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).

  • Severity of Adverse Events and Serious Adverse Events [ Time Frame: week 0 through week 72 ]
    Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).

Estimated Enrollment:40
Actual Study Start Date:May 23, 2017
Estimated Study Completion Date:October 2020
Estimated Primary Completion Date:July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1

6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period.
Drug: Secukinumab

Arms: Group 1 – Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
Other Name: COSENTYX
Placebo Comparator: Group 2

Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period.
Drug: Placebo followed by Secukinumab

Arms: Group 2 – Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
Other Name: Placebo followed by COSENTYX

Detailed Description:

Psoriasis is an immune-mediated disease of the skin that, even in mild disease, increases the risk of comorbidities such as cardiovascular disease and metabolic derangements. Mild psoriasis tends to be treated with topical drugs, while moderate-to-severe disease is optimally treated with systemic immune modulators. However, the treatment of “mild” psoriasis needs to be re-thought because recent studies have revealed that mild psoriasis is characterized by stronger expression of pathogenic molecules, such as interleukin (IL)-17A, and higher numbers of T cells in the skin, compared to severe psoriasis. A key distinction between mild and severe psoriasis is now discovered to be the higher expression of negative immune regulatory genes in mild lesions. Therefore, targeted immune therapy with anti-IL-17A, which is highly effective in severe psoriasis, might be equally (or even more) effective in mild disease. Also, restoration of immune tolerance might be more easily achieved in mild disease. Thus, short-term anti-IL-17A treatment of mild psoriasis might prevent the recurrence and eventually cure the disease. The aim of study is to test this hypothesis by exploring whether 3 months or 6 months of anti-IL17A treatment will prevent relapses after medication has been discontinued in mild psoriasis patients.

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