NCT03958955终止2 期
Efficacy and Safety of Twice-daily Application of Delgocitinib Cream 20 mg/g for 6 Weeks in Subjects With Active Discoid Lupus Erythematosus.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6.
研究概览
简要总结
This was a double-blind, multi-centre, randomised, vehicle-controlled, within-subject phase 2a trial. The trial was designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological findings (current or previous) consistent with clinical diagnosis of DLE.
- •Unequivocal clinical diagnosis of 2 active DLE target lesions that were <6 months old and amenable for clinical evaluation. This included lesions located on the scalp if they fulfilled all lesion-specific eligibility criteria.
- •Target lesion IGA score of at least moderate severity (≥3) at screening and baseline.
- •Target lesion erythema score ≥2 at screening and baseline.
排除标准
- •Target lesion dyspigmentation score of 2 at screening or baseline.
- •Target lesion scarring/atrophy score of 2 at screening or baseline.
- •Target lesion scarring alopecia score of >0 in scalp lesions at screening or baseline.
- •Medical history of systemic lupus erythematosus (SLE) with clinically significant organ involvement (American College of Rheumatology SLE classification criteria no. 6 to 9) including SLE-related pleuritis or pericarditis (by clinical evaluation and electrocardiogram), and neurologic, renal, and/or other major SLE-related organ system involvement. SLE joint involvement was acceptable.
- •Subjects with unstable or significant SLE disease activity findings that would, by its progressive nature and/or severity, interfere with the trial evaluation, completion, and/or procedures per the investigator's discretion.
- •Other skin conditions at screening or baseline that would interfere with the evaluation of DLE.
- •Immunosuppressive/immunomodulating therapy with e.g. methotrexate, cyclosporine, azathioprine, retinoids (both topical and systemic), or dapsone within 4 weeks prior to baseline.
- •Systemic prednisolone >7.5 mg/day or changed dose within 4 weeks prior to baseline (nasal and inhaled corticosteroids were allowed).
- •Treatment with the following medications:
- •Oral antimalarial treatment with hydroxychloroquine >6.5 mg/kg body weight/day, or chloroquine >4 mg/kg body weight/day, or changed dose within 12 weeks prior to baseline.
- •Quinacrine combined with either hydroxychloroquine or chloroquine within 12 weeks prior to baseline.
- •Drugs known to interact with antimalarials (e.g. digoxin, cimetidine) within 12 weeks prior to baseline.
- •Treatment with topical corticosteroids, calcineurin inhibitors, and phosphodiesterase-4 (PDE-4) inhibitors within 2 weeks prior to baseline.
- •Use of systemic antibiotics or cutaneously applied antibiotics on the target lesions within 2 weeks prior to baseline.
- •Ultraviolet (UV) therapy within 2 weeks prior to baseline.
- •Any procedure impairing the skin barrier (e.g. incision) within 2 cm from the border of any of the target lesions within 4 weeks prior to baseline.
- •Receipt of live (attenuated) vaccines within 4 weeks 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 returned to normal, whichever was longer.
- •Other biologics: within 3 months or 5 half-lives, whichever was longer, prior to baseline.
- •Unstable or fluctuating use of tobacco within 1 month prior to screening which, in the opinion of the investigator, could affect the natural course of the disease and thus affect the evaluation of the treatment.
- •History of any active skin infection within 1 week prior to baseline.
- •Clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, could compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial. Clinically significant infections are defined as:
- •A systemic infection.
- •A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
- •Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening. Subjects with high risk of latent tuberculosis (e.g. prior residence in or travel to countries with high prevalence of tuberculosis, close contact with a person with active tuberculosis, or a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed) must have been tested at screening.
研究组 & 干预措施
Delgocitinib cream 20 mg/g
Experimental
Delgocitinib cream applied twice daily for 6 weeks
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream vehicle
Placebo Comparator
Delgocitinib cream vehicle applied twice daily for 6 weeks
干预措施: Delgocitinib cream vehicle (Drug)
结局指标
主要结局
Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6.
时间窗: Week 6
The IGA is an instrument used in clinical trials to rate the severity of the subject's global disease and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). In this trial, the IGA was a lesion-specific assessment and was evaluated separately for each of the 2 target lesions.
次要结局
- Number of Subjects With AEs up to Week 6.(Week 0 to Week 6)
- Number of Lesion-specific, Treatment-related AEs up to Week 6.(Week 0 to Week 6)
- Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at Week 6.(Week 6)
- Number of Adverse Events (AEs) up to Week 6.(Week 0 to Week 6)
- Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline.(Week 0 to Week 6)
- Erythema Score at Week 6.(Week 6)
- Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline.(Week 0 to Week 6)
研究者
研究点 (2)
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