2024-518856-21-00尚未招募2 期
A proof-of-concept phase 2a, double-blind, 2-arm trial to investigate efficacy and safety of twice daily delgocitinib cream 20 mg/g compared with cream vehicle during a 16-week treatment period in adult subjects with mild to severe palmoplantar pustulosis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 17
- 主要终点
- PPPASI-75 at Week 16
研究概览
简要总结
To evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult subjects with mild to severe PPP.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Subject, Monitor, Investigator, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- •Age 18 years or above at the time of informed consent signing.
- •Subject is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.
- •Diagnosis of PPP in accordance with the consensus diagnostic criteria established by the European Rare and Severe Psoriasis Expert Network (ERASPEN): primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, with or without plaque psoriasis elsewhere on the body.
- •Confirmed PPP by central evaluation of photographs taken at screening.
- •Mild to severe PPP current condition defined by: • Disease duration of PPP of >6 months before randomisation. • PPP-PGA of at least mild severity (PPP-PGA ≥2) at screening and baseline. • Palmoplantar Pustulosis Area and Severity Index (PPPASI) ≥8 at screening and baseline.
- •Presence of ≥5 well-demarcated fresh pustules (white or yellow pustules) in total across all affected areas at screening and baseline.
- •Subjects with prior experiences of inadequate response with topical corticosteroids (TCS) or for whom TCS are inadvisable, as judged by the investigators.
- •A woman of childbearing potential must use an acceptable form of birth control throughout the trial up until the last administration of IMP.
排除标准
- •Presence or known history of drug-induced PPP
- •Any disorder which is not stable and could: • Affect the safety of the subject throughout the trial. • Impede the subject’s ability to complete the trial.
- •Any clinically significant abnormal findings occurring during the screening period and/or observed at the baseline visit that may put the subject at risk because of their participation in the trial, or can influence the subjects ability to complete the trial.
- •Positive hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus DNA (subjects who have tested positive for hepatitis B core antibody are eligible if tests for hepatitis B surface antigen and hepatitis B virus DNA are negative), or positive hepatitis C virus antibody serology confirmed by hepatitis C virus RNA at screening.
- •Known or suspected hypersensitivity to any component(s) of the IMP.
- •Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.
- •Women who are pregnant or lactating.
- •Systemic treatment within 4 weeks prior to baseline with immunosuppressive, immunomodulating drugs, retinoids tyrosine kinase inhibitors, phosphodiesterase-4 inhibitors, or corticosteroids.
- •Use of tanning beds or phototherapy on the palms or soles within 4 weeks prior to baseline.
- •Use of systemic or topical janus kinase inhibitors within 4 weeks prior to baseline.
- •Cutaneously applied treatment with immunomodulators or TCS on the palms or soles within 2 weeks prior to baseline.
- •Presence of acrodermatitis continua of Hallopeau.
- •Use of systemic antibiotics or cutaneously applied antibiotics on the palms or soles within 2 weeks prior to baseline.
- •Other transdermal or cutaneously applied therapy on the palms or soles (except for the use of subject’s own non-medicated emollients) within 1 week prior to baseline
- •Cutaneously applied treatments in regions other than the palms or soles, which could interfere with clinical trial evaluations or pose a safety concern (excluding treatments for psoriasis patches or other non-exclusionary skin conditions, if needed) within 1 week prior to baseline.
- •Treatment with any marketed biological therapy or investigational biologic agents: • Any cell-depleting agents including, but not limited to, rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. • Other biologics, including but not limited to, secukinumab, ustekinumab, tildrakizumab, ixekizumab, risankizumab, guselkumab, and tumour necrosis factor-alpha inhibitors: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- •Treatment with any nonmarketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to baseline or 5 half-lives, whichever is longer.
- •Current participation in any other interventional clinical trial.
- •Previously randomised in this clinical trial.
- •Previously randomised in a clinical trial with delgocitinib.
- •Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.
- •Active dermatologic condition that could confound the diagnosis of PPP or interfere with assessment of the IMP, as assessed by the investigator
- •Clinically significant infection on the palms or soles.
- •Concurrent plaque psoriasis covering >5% of body surface area.
- •Clinically significant infection within 4 weeks prior to baseline. Clinically significant infections are defined as: • A systemic infection. • A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, parenteral antiviral, or parenteral antifungal medication.
- •History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus test at screening
- •Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalisation during the trial period
- •Any documented active or suspected malignancy, or history of malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix appropriately treated before the baseline visit.
结局指标
主要结局
PPPASI-75 at Week 16
PPPASI-75 at Week 16
次要结局
- PPP-PGA score of 0 or 1 (clear or almost clear) with at least a 2-step improvement from baseline at Week 16.
- Change in overall number of fresh pustules from baseline to Week 16.
研究者
LEO Pharma Clinical Trials mailbox
Scientific
Leo Pharma A/S
研究点 (17)
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