Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Study Identifier
M15-994
CT.gov Identifier
NCT04713592
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
Available Language(s): English, Spanish (United States)
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
  • Placebo for Risankizumab
  • Risankizumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline. * Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles. * Must be a candidate for systemic therapy as assessed by the investigator. * Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.
    Exclusion Criteria:
    * History of PsO other than chronic plaque type PsO * History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis. * Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments. * Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline. * Prior exposure to risankizumab.

    Protocol Summary

    Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms.

    Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world.

    Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Advanced Research Associates - Glendale /ID# 219197
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Burke Pharmaceutical Research /ID# 223349
    Hot Springs, Arkansas, United States, 71913-6404
    Status
    Not applicable
    Location
    NW Arkansas Clinical Trials Center /ID# 231602
    Rogers, Arkansas, United States, 72758
    Status
    Not applicable
    Location
    Dermatology Research Associates /ID# 219195
    Los Angeles, California, United States, 90045
    Status
    Not applicable
    Location
    Integrative Skin Science and Research /ID# 219216
    Sacramento, California, United States, 95815
    Status
    Not applicable
    Location
    Medderm Associates /ID# 219210
    San Diego, California, United States, 92103
    Status
    Not applicable
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