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
- Registration Number
- NCT04713592
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Risankizumab Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. Risankizumab Risankizumab Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. Placebo Placebo for Risankizumab Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 Baseline, Week 16 The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."
Number of Participants With Treatment-Emergent Adverse Events From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks) An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16 Baseline, Week 16 PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 Baseline, Week 16 sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Higher scores indicate more severe disease.
Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16 Baseline, Week 16 PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.
Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16 Baseline, Week 16 PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.
Trial Locations
- Locations (55)
Advanced Research Associates - Glendale /ID# 219197
🇺🇸Glendale, Arizona, United States
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
Scroll for more (45 remaining)Advanced Research Associates - Glendale /ID# 219197🇺🇸Glendale, Arizona, United States