NCT07542483招募中3 期
A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema Who Are Not Adequately Controlled With Topical Corticosteroids or When This Treatment is Not Medically Advisable (LUMINE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24
研究概览
简要总结
The main aim of the study is to evaluate the efficacy, safety, and tolerability of lebrikizumab treatment in adult participants with Nummular Eczema (NE) who are not adequately controlled with Topical corticosteroids (TCS) or when this treatment is not medically advisable.
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
- •Participants eligible for inclusion in this trial must fulfil all inclusion criteria per protocol, main criteria are listed below:
- •Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines.
- •Adult (aged 18 years or more at the time of Screening) diagnosed clinically with NE, as confirmed by the Investigator.
- •Presence of nummular eczema signs and/or symptoms for at least 6 months prior to Screening.
- •Investigator Global Assessment score >=3 at both Screening and Baseline/Day 1 visits.
- •In the judgement of the Investigator, having inadequate response to TCS.
排除标准
- •Participants fulfilling any of the exclusion criteria per protocol are not eligible for inclusion in this trial main criteria are listed below:
- •Documented history or current presence of moderate-to-severe AD at the Screening visit, or documented diagnosis of moderate-to-severe AD from Screening to Baseline/Day 1 visit (ie, EASI >=16).
- •Presence of any skin disease, other than NE or mild AD, that could interfere with assessment of the study outcomes, including but not limited to psoriasis and other forms of eczema (dyshidrotic eczema, stasis dermatitis, asteatotic eczema, and neurodermatitis).
- •Presence of any skin manifestations suggestive of psoriasis including but not limited to nail pitting, scalp, palms, soles, or skin folds involvement, as well as personal or family history of psoriasis or psoriatic arthritis.
- •Prior treatment at any time with lebrikizumab, dupilumab, tralokinumab, or oral Janus kinase inhibitor.
- •Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever was longer, prior to Screening.
- •Intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.
- •History of anaphylaxis as defined by the Sampson criteria.
- •Uncontrolled chronic disease that might require multiple intermittent uses of systemic corticosteroids, eg, uncontrolled asthma.
- •Have had any of the following types of infection within 3 months of Screening or develop any of these infections before Baseline/Day 1:
- •Serious (requiring hospitalisation and/or intravenous or equivalent oral antibiotic treatment, per the Investigator's opinion)
- •Opportunistic (as defined by Winthrop 2015) Note: herpes zoster is considered active and ongoing until all vesicles are dry and crusted over
- •Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer), including hepatitis B virus and hepatitis C virus infections
- •Recurring (including but not limited to herpes zoster, recurring cellulitis, and chronic osteomyelitis) with the exception of uncomplicated herpes simplex infection, which is not considered exclusionary
- •Known liver cirrhosis and/or chronic hepatitis of any aetiology.
- •Diagnosed active endoparasitic infections or at high risk of these infections.
- •Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgement.
- •History of human immunodeficiency virus (HIV) infection or known positive HIV serology.
- •In the Investigator's opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit.
- •History of malignancy, including mycosis fungoides/cutaneous T-cell lymphoma, within 5 years before the Screening visit, except for completely treated in situ carcinoma of the cervix or completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
- •Severe concomitant illness(es) that in the Investigator's judgement would adversely affect the participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study participant because of their participation in this clinical trial, may make participation unreliable, or may interfere with study assessments.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- •History of sensitivity and/or allergy to any of the ingredients of the trial medication.
研究组 & 干预措施
Placebo-controlled Period: Lebrikizumab
Experimental
干预措施: Lebrikizumab (Drug)
Blinded Extension Period: Lebrikizumab
Experimental
干预措施: Lebrikizumab (Drug)
Placebo-controlled Period: Placebo
Placebo Comparator
干预措施: Placebo (Other)
Blinded Extension Period: Lebrikizumab + Placebo
Experimental
干预措施: Lebrikizumab (Drug)
Blinded Extension Period: Lebrikizumab + Placebo
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24
时间窗: Baseline, Week 24
The IGA is an instrument used to globally rate the severity of a participants.
次要结局
- Percentage of Participants with Pruritus Numerical Rating Scale (NRS) >=4 at Baseline Achieving a >=4-point Improvement in Pruritus NRS Score from Baseline at Week 24(Baseline, Week 24)
- Absolute Change from Baseline in Dermatology Quality of Life Index (DLQI) to Week 24(Baseline up to Week 24)
- Percentage of Participants Achieving a 50 Percent (%) Reduction in Body Surface Area (BSA) from Baseline at Week 24(Baseline, Week 24)
- Percentage Change in Eczema Area and Severity Index (EASI) from Baseline at Week 24 in Participants with Atopic Dermatitis (AD)(Baseline, Week 24)
- Absolute Change from Baseline in European Quality of Life Survey (EQ-5D-5L) at Week 24(Baseline, Week 24)
- Absolute Change from Baseline in Patient Global Assessment of Disease Status (PGADS) at Week 24(Baseline, Week 24)
- Absolute Change in Skin Pain NRS Score from Baseline at Week 24(Baseline, Week 24)
- Absolute Change in ItchyQoL from Baseline at Week 24(Baseline, Week 24)
- Change from Baseline in Patient Global Impression of Severity (PGI-S) at Week 24(Baseline, Week 24)
- Change from Baseline in PGI-S Itch at Week 24(Baseline, Week 24)
- Patient Global Impression of Change (PGI-C) at Week 24(At Week 24)
- PGI-C Itch at Week 24(At Week 24)
- Clinical Global Impression of Change (CGI-C) at Week 24(At Week 24)
- Change from Baseline in Clinical Global Impression of Severity (CGI-S) at Week 24(Baseline, Week 24)
- Percentage of Participants with DLQI >=4 at Baseline Achieving DLQI >=4-point Improvement from Baseline at Week 24(Baseline, Week 24)
- Percentage of Participants Achieving an IGA Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 48 Among those Participants who Achieved this Response at Week 24(Baseline, Week 48)
- Percentage of Participants with Pruritus NRS >=4 at Baseline Achieving a >=4-point Improvement in Pruritus NRS Score from Baseline at Week 48, Among those Participants who Achieved this Response at Week 24(Baseline, Week 48)
- Percentage of Participants Achieving DLQI >=4-point Improvement from Baseline, from Week 24 up to Week 48, Among those Participants who Achieved this Response at Week 24(Baseline, Week 24 up to Week 48)
- Absolute Change from Baseline in DLQI to Week 48(Baseline up to Week 48)
研究者
研究点 (1)
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