NCT04594928已完成1 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GLPG3667 in Subjects With Moderate to Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation in subjects with moderate to severe plaque psoriasis.
研究概览
简要总结
The purpose of this research study is to assess the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG3667 in multiple daily oral doses in subjects with moderate to severe plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be male or female between 18-64 years of age (extremes included), on the date of signing the informed consent form (ICF).
- •Subject must be diagnosed (for at least 6 months before screening) of moderate to severe intensity plaque psoriasis. Subject's plaque psoriasis must be stable, defined as no flare during the month before the screening visit and no change of the severity between the screening visit and baseline visit.
- •At screening and at baseline (Day 1, predose), PASI >=12 (moderate to severe) and plaque-type psoriasis covering at least 10% of total body surface area (BSA).
- •At screening a Physician's Global Assessment (PGA ) score of 3 ("moderate") or 4 ("severe").
- •Subject must be considered by dermatologist investigator to be a candidate for systemic therapy of plaque psoriasis (either naïve or history of previous systemic treatment).
- •This list only contains the key inclusion criteria.
排除标准
- •Subject has a known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
- •Subjects with psoriasis other than plaque type or complicated psoriasis such as guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected, or ulcerated psoriasis.
- •Subject has evidence of skin conditions other than psoriasis (e.g. eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis.
- •Subject is unable to discontinue prohibited therapies for the treatment of plaque psoriasis and/or cannot discontinue phototherapy (ultraviolet B (UVB) or psoralen and ultraviolet A (PUVA)) before the start of the study up to the end of the study.
- •Subjects with current or a known or suspected history of immunosuppressive condition, history of invasive opportunistic infections (e.g. human immunodeficiency virus (HIV) infection, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis, or organ or bone marrow transplantation).
- •Subjects having an active clinically significant infection or any infection requiring oral or systemic therapy within 2 weeks prior screening or subjects currently on any chronic oral or systemic antiinfective therapy for chronic infection.
- •Subject testing positive for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as detected at screening based on real time polymerase chain reaction (RT-PCR) or at baseline based on Immunoglobulin M (IgM) immunoassay, or subjects who have been in contact with SARS-CoV-2 infected individuals in the two weeks prior to first dosing of IP. Subjects presenting any signs or symptoms of SARS-Cov-2 infection as detected at screening or baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, etc.). In addition, any other locally applicable standard diagnostic criteria may also apply to diagnose SARS-CoV-2 infection.
- •Subjects with evidence of active or latent infection with Mycobacterium tuberculosis (TB) as defined by:
- •Positive QuantiFERON-TB Gold test result, AND/OR
- •Chest radiograph (posterior anterior view) taken within 12 weeks prior to screening, read by a qualified radiologist or pulmonologist, with evidence of current active TB or old inactive TB.
- •Subjects with a history of TB who have successful treatment documentation are eligible for the study.
- •This list only contains the key exclusion criteria.
研究组 & 干预措施
GLPG3667 Dose A
Experimental
Daily doses of GLPG3667 for 4 weeks.
干预措施: GLPG3667 (Drug)
GLPG3667 Dose B
Experimental
Daily doses of GLPG3667 for 4 weeks.
干预措施: GLPG3667 (Drug)
Placebo
Placebo Comparator
Placebo to match will be administered as capsules for daily oral use.
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation in subjects with moderate to severe plaque psoriasis.
时间窗: From screening through study completion, an average of 3 months
To evaluate the safety and tolerability of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.
Psoriasis Area and Severity Index (PASI) % change
时间窗: At week 4
To evaluate signs of clinical efficacy of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.
次要结局
- Observed GLPG3667 plasma trough concentrations (Ctrough).(Between Day 1 pre-dose and Day 30)
- Change from baseline in interleukin 17 [IL-17] levels between treatment groups and time points.(Between Day 1 pre-dose and Day 60)
研究者
研究点 (7)
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