A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 128
- 主要终点
- Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.
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
- Double (Participant, Investigator)
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
- •All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
- •All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (>=) 3, face with facial psoriasis IGA >=3, intertriginous with intertriginous psoriasis IGA >=3, or genital with static physician global assessment of genitalia (sPGA-G) >=3
- •All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
- •All participants be a candidate for phototherapy or systemic treatment for psoriasis
排除标准
- •Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
- •Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
- •Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
- •Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
研究组 & 干预措施
Group 1: Guselkumab
Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
干预措施: Placebo (Drug)
Group 2: Placebo
Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
干预措施: Placebo (Drug)
Group 1: Guselkumab
Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
干预措施: Guselkumab (Drug)
Group 2: Placebo
Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
干预措施: Guselkumab (Drug)
结局指标
主要结局
Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
时间窗: Week 16
Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 16 will be reported. The IGA documents the investigator's assessment of the participant's psoriasis. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
时间窗: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (\>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.
次要结局
- Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) at Week 16(Week 16)
- Percentage of Participants who Achieve >=4 Point Reduction (Improvement) in PSSD Itch Score From Baseline at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline(Week 16)
- Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16(Baseline, Week 16)
- Percentage of Participants who Achieve a Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an f-IGA Score >=3 at Baseline(Week 16)
- Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16(Baseline, Week 16)
- Percentage of Participants who Achieve a PASI 90 Response at Week 16(Week 16)
- Percentage of Participants who Achieve a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With a sPGA-G Score >=3 at Baseline(Week 16)
- Percentage of Participants who Achieve an Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an i-IGA Score >=3 at Baseline(Week 16)
- Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16(Baseline, Week 16)
- Percentage of Participants With PSSD Individual Symptom Scale Score of 0 at Week 16 Among Participants With PSSD >0 at Baseline(Week 16)
- Number of Participants With Adverse Events (AEs)(Up to Week 56)
- Percentage of Participants who Achieve a PASI 100 Response at Week 16(Week 16)
- Percentage of Participants who Achieve a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Participants With an ss-IGA Score >=3 at Baseline(Week 16)
- Number of Participants With Serious Adverse Events (SAEs)(Up to Week 56)
- Percent Change From Baseline in Body Surface Area (BSA) at Week 16(Baseline (Week 0), Week 16)
- Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Total Score at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16(Week 16)
- Percentage of Participants Who Achieved PASI 90 Response at Week 16(Week 16)
- Percentage of Participants Who Achieved PASI 100 Response at Week 16(Week 16)
- Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Randomized Participants With Ss-IGA Score >=3 at Baseline(Week 16)
- Percentage of Participants Who Achieved PSSD Individual Symptom Scale Score=0 at Week 16 Among Participants With a PSSD Symptom Score >0 at Baseline(Week 16)
- Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16 Among Randomized Participants With sPGA-G Score >=3 at Baseline(Week 16)
- Percentage of Participants Who Achieved Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With an i-IGA Score >=3 at Baseline(Week 16)
- Percentage of Participants Who Achieved Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With f-IGA Score >=3 at Baseline(Week 16)
- Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline(Week 16)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56)
- Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)(Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56)