IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 55
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
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.
干预措施: Placebo for Risankizumab (Drug)
Placebo
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.
干预措施: Risankizumab (Drug)
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.
干预措施: Risankizumab (Drug)
结局指标
主要结局
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
时间窗: 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
时间窗: 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.
次要结局
- Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16(Baseline, Week 16)
- 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)