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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT04713592

Run by

AbbVie

People needed

174

Starts

2021-02-26

Expected to finish

2023-04-20

Last updated by the study team

2024-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Burke Pharmaceutical Research /ID# 223349 — Hot Springs, Arkansas, United States
• NW Arkansas Clinical Trials Center /ID# 231602 — Rogers, Arkansas, United States
• Dermatology Research Associates /ID# 219195 — Los Angeles, California, United States
• Integrative Skin Science and Research /ID# 219216 — Sacramento, California, United States
• Medderm Associates /ID# 219210 — San Diego, California, United States
• Colorado Center for Dermatology, PLLC /ID# 219223 — Centennial, Colorado, United States
• Skin Care Research - Hollywood /ID# 219184 — Hollywood, Florida, United States
• GSI Clinical Research, LLC /ID# 219175 — Margate, Florida, United States
• Savin Medical Group, LLC /ID# 227754 — Miami Lakes, Florida, United States
• Lenus Research & Medical Group /ID# 219202 — Sweetwater, Florida, United States
• Hamilton Research, LLC /ID# 219224 — Alpharetta, Georgia, United States
• Arlington Dermatology /ID# 219211 — Rolling Meadows, Illinois, United States
• Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220 — Skokie, Illinois, United States
• Dawes Fretzin, LLC /ID# 219219 — Indianapolis, Indiana, United States
• The Dermatology Center PSC - New Albany /ID# 219183 — New Albany, Indiana, United States
• Epiphany Dermatology of Kansas LLC /ID# 219208 — Overland Park, Kansas, United States
• Allcutis Research LLC /ID# 222272 — Methuen, Massachusetts, United States
• David Fivenson, MD, PLC /ID# 219180 — Ann Arbor, Michigan, United States
• Henry Ford Medical Center /ID# 219205 — Detroit, Michigan, United States
• Advanced Dermatology of the Midlands /ID# 219207 — Omaha, Nebraska, United States
• Psoriasis Treatment Center of Central New Jersey /ID# 219201 — East Windsor, New Jersey, United States
• Forest Hills Dermatology Group /ID# 219200 — Kew Gardens, New York, United States
• Icahn School of Medicine at Mount Sinai /ID# 219206 — New York, New York, United States
• ClinOhio Research Services /ID# 222298 — Columbus, Ohio, United States
• Advanced Research Associates - Glendale /ID# 219197 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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