NCT07542483
Not yet recruiting
Phase 3
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)
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Almirall, S.A.
- Enrollment
- 270
- Primary Endpoint
- Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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:
Arms & Interventions
Placebo-controlled Period: Lebrikizumab
Experimental
Intervention: Lebrikizumab (Drug)
Blinded Extension Period: Lebrikizumab + Placebo
Experimental
Intervention: Placebo (Other)
Placebo-controlled Period: Placebo
Placebo Comparator
Intervention: Placebo (Other)
Blinded Extension Period: Lebrikizumab
Experimental
Intervention: Lebrikizumab (Drug)
Blinded Extension Period: Lebrikizumab + Placebo
Experimental
Intervention: Lebrikizumab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24
Time Frame: Baseline, Week 24
The IGA is an instrument used to globally rate the severity of a participants.
Secondary Outcomes
- 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)
Investigators
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