Psoriasis Clinical Trial
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
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.
Eligibility 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.
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There are 53 Locations for this study
Glendale Arizona, 85308, United States
Hot Springs Arkansas, 71913, United States
Rogers Arkansas, 72758, United States
Los Angeles California, 90045, United States
Sacramento California, 95815, United States
San Diego California, 92103, United States
Centennial Colorado, 80111, United States
Hollywood Florida, 33021, United States
Margate Florida, 33063, United States
Miami Lakes Florida, 33014, United States
Sweetwater Florida, 33172, United States
Alpharetta Georgia, 30022, United States
Rolling Meadows Illinois, 60008, United States
Skokie Illinois, 60077, United States
Indianapolis Indiana, 46256, United States
New Albany Indiana, 47150, United States
Overland Park Kansas, 66210, United States
Methuen Massachusetts, 01844, United States
Ann Arbor Michigan, 48103, United States
Detroit Michigan, 48202, United States
Omaha Nebraska, 68144, United States
East Windsor New Jersey, 08520, United States
Kew Gardens New York, 11415, United States
New York New York, 10029, United States
Columbus Ohio, 43213, United States
Pittsburgh Pennsylvania, 15260, United States
Warwick Rhode Island, 02886, United States
Fountain Inn South Carolina, 29644, United States
Fountain Inn South Carolina, 29644, United States
Murfreesboro Tennessee, 37130, United States
Dallas Texas, 75246, United States
Houston Texas, 77004, United States
Salt Lake City Utah, 84117, United States
Norfolk Virginia, 23507, United States
Calgary Alberta, T3E 0, Canada
Surrey British Columbia, V3R 6, Canada
Fredericton New Brunswick, E3B 1, Canada
St. John's Newfoundland and Labrador, A1C 2, Canada
Newmarket Ontario, L3Y 5, Canada
Toronto Ontario, M4W 2, Canada
Montréal Quebec, H2X 2, Canada
Québec Quebec, G1V 4, Canada
Caguas , 00727, Puerto Rico
Carolina , 00985, Puerto Rico
Rio Piedras , 00935, Puerto Rico
San Juan , 00909, Puerto Rico
San Juan , 00909, Puerto Rico
Málaga Malaga, 29010, Spain
Bilbao Vizcaya, 48013, Spain
Madrid , 28006, Spain
Madrid , 28034, Spain
Sevilla , 41013, Spain
Valencia , 46014, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
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