JPRN-jRCT2061230086招募中2 期
A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging study of Efficacy and Safety of SAR441566 in Adults with Moderate to Severe Plaque Psoriasis
Tanaka Tomoyuki0 个研究点目标入组 207 人开始时间: 2024年1月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 207
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Participants with moderate to severe plaque psoriasis for at least 6 months, meeting the following criteria at screening and Day 1 (prior to randomization):
- •- - Psoriasis area and severity index (PASI) >=12 points; and
- •- - Static psoriasis global assessment (sPGA) score >=3 points; and
- •- - Body surface area (BSA) score >=10%.
- •- Must be a candidate for phototherapy or systemic therapy.
- •- Total body weight >=50 kg (110 lb) and body mass index (BMI) within the range [18 - 35] kg/m^2 (inclusive).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis or pustular psoriasis. Nail psoriasis is accepted for inclusion.
- •- Plaque psoriasis is restricted to scalp, palms, soles, or flexures only.
- •- Any other skin diseases that can interfere with psoriasis evaluation or treatment response (eg, atopic dermatitis, fungal or bacterial superinfection).
- •- Other immunologic (autoimmune or inflammatory) disorder, except medically controlled diabetes or thyroid disorder as per Investigator's judgement.
- •- History of recurrent or recent serious infection (eg, pneumonia, septicemia), or infection(s) requiring hospitalization or treatment with intravenous anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to Day 1, or infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to Day 1.
- •- Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •- Participant with personal or family history of long QT syndrome.
- •- History of moderate to severe congestive heart failure (New York Heart Association Class III or IV), or recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol.
- •- History of solid organ transplant.
- •- History of alcohol or drug abuse within the past 2 years.
- •- History of diagnosis of demyelinating disease such as but not limited to:
- •- - Multiple Sclerosis
- •- - Acute Disseminated Encephalomyelitis
- •- - Balo's Disease (Concentric Sclerosis)
- •- - Charcot-Marie-Tooth Disease
- •- - Guillain-Barre Syndrome
- •- - Human T-lymphotropic virus 1 Associated Myelopathy
- •- - Neuromyelitis Optica (Devic's Disease)
- •- Planned surgery during the treatment period.
- •- Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.
- •- Any live (attenuated) vaccine within 6 weeks prior to randomization (eg, varicella zoster vaccine, oral polio, rabies) or plan to receive one during the trial.
研究者
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