Home / Psoriasis / A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

  Purpose

The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in subjects with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.

Condition Intervention Phase
Psoriasis Drug: risankizumab Drug: Fumaderm Phase 3

Study Type: Interventional
Study Design:Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:A Randomized, Controlled, Multicenter, Open Label Study With Blinded Assessment of the Efficacy of the Humanized Anti-IL 23p19 Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:

  • Percentage of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 24 [ Time Frame: Week 24 ]
    Denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

Secondary Outcome Measures:

  • Percentage of participants with a PASI 50 response [ Time Frame: Up to 24 weeks ]
    Denotes greater than or equal to 50% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  • Percentage of participants with a PASI 75 response [ Time Frame: Up to 24 weeks ]
    Denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  • Percentage of participants with a PASI 90 response [ Time Frame: Up to 24 weeks ]
    Denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  • Percentage of participants with a PASI 100 response [ Time Frame: Up to 24 weeks ]
    Denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  • Change from Baseline in PASI [ Time Frame: Up to 24 weeks ]
    PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  • Change from Baseline in Body Surface Area (BSA) affected by psoriasis [ Time Frame: Up to 24 weeks ]
    BSA affected by psoriasis as assessed by the Investigator.

  • Percentage of participants with Static Physician Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) [ Time Frame: Up to 24 weeks ]
    The sPGA is the physician’s current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).

  • Percentage of participants with sPGA score of 0 (clear) [ Time Frame: Up to 24 weeks ]
    The sPGA is the physician’s current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).

  • Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) [ Time Frame: Up to 24 weeks ]
    The PPASI combines the percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation.

  • Change from Baseline in Psoriasis Scalp Severity Index (PSSI) [ Time Frame: Up to 24 weeks ]
    The PSSI is used by the physician to assess scalp psoriasis, including the erythema (redness), induration (hardness), desquamation (shedding of skin) and percent of scalp covered.

  • Change from Baseline in Clinical Severity of Nail Psoriasis (NAPPA-CLIN) [ Time Frame: Up to 24 weeks ]
    The NAPPA-CLIN is used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis).

  • Change from Baseline in Psoriasis Symptom Scale (PSS) [ Time Frame: Up to 24 weeks ]
    The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis.

  • Percentage of participants with PSS of 0 (none) [ Time Frame: Up to 24 weeks ]
    The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. Scores range from 0 (none) to 4 (very severe).

  • Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Up to 24 weeks ]
    The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject’s quality of life, overall health, and disability status.

  • Percentage of participants with DLQI scores of 0 (not relevant/not at all) or 1 (a little) [ Time Frame: Up to 24 weeks ]
    The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject’s quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much).

  • Change from Baseline in Medical Outcomes Short Form Health Survey 36, version 2 (SF-36 V2): Physical Component Summary (PCS) Score [ Time Frame: Up to 24 weeks ]
    The SF-36 V2 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health.

  • Change from Baseline in Medical Outcomes Short Form Health Survey 36, version 2 (SF-36 V2): Mental Component Summary (MCS) Score [ Time Frame: Up to 24 weeks ]
    The SF-36 V2 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health.

  • Change from Baseline in Patient Benefit Index (PBI) [ Time Frame: Up to 24 weeks ]
    The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.

  • Change from baseline in Hospital Anxiety & Depression Scale (HADS) [ Time Frame: Up to 24 weeks ]
    The HADS is a self-assessment scale which detects the presence and severity of anxiety and depression in the general population.

  • Change from Baseline in Patient’s Global Assessment (PtGA) [ Time Frame: Up to 24 weeks ]
    The PtGA is a patient-reported outcome instrument to assess the patient’s assessment of disease severity.

  • Change from Baseline in the European Quality of Life 5 Dimensions (EQ-5D-5L) . [ Time Frame: Up to 24 weeks ]
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life

Estimated Enrollment:110
Actual Study Start Date:August 22, 2017
Estimated Study Completion Date:August 14, 2018
Estimated Primary Completion Date:August 14, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risankizumab

Participants randomized to receive risankizumab for16 weeks.
Drug: risankizumab

subcutaneous injection
Other Names:

  • ABBV-066
  • BI 655066
Active Comparator: Fumaderm

Participants to received Fumaderm for 24 weeks.
Drug: Fumaderm

tablet

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