A Study of Lebrikizumab in Adults With Nummular Eczema

Phase 3Not Yet RecruitingNCT07542483

Almirall, S.A.270 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

270

Conditions

Nummular Eczema

Interventions

LebrikizumabDRUG

Lebrikizumab SC injection.

PlaceboOTHER

Matching placebo SC injection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. Serious (requiring hospitalisation and/or intravenous or equivalent oral antibiotic treatment, per the Investigator's opinion) 2. Opportunistic (as defined by Winthrop 2015) Note: herpes zoster is considered active and ongoing until all vesicles are dry and crusted over 3. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer), including hepatitis B virus and hepatitis C virus infections 4. 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.

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

The IGA is an instrument used to globally rate the severity of a participants.

Time frame: Baseline, Week 24

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

The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity during the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable".

Time frame: Baseline, Week 24

Absolute Change from Baseline in Dermatology Quality of Life Index (DLQI) to Week 24

The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.

Time frame: Baseline up to Week 24

Percentage of Participants Achieving a 50 Percent (%) Reduction in Body Surface Area (BSA) from Baseline at Week 24

BSA assessment estimates the extent of disease or skin involvement with respect to NE and is expressed as a percentage of total body surface. Body surface area will be determined by the Investigator or designee using the participant palm=1% BSA rule.

Time frame: Baseline, Week 24

Absolute Change from Baseline in European Quality of Life Survey (EQ-5D-5L) at Week 24

EQ-5D-5L is a standardised measure of health status that provides a profile of participant health on the day of questionnaire completion. It consists of 2 parts: a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression), each of which have 5 response levels of perceived problems, and a visual analogue scale scoring overall health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health).

Central Contacts

Estrella Garcia

CONTACT

+34620985953 gco@almirall.com

Natalia Calderón

CONTACT

gco@almirall.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Baseline, Week 24

Absolute Change from Baseline in Patient Global Assessment of Disease Status (PGADS) at Week 24

PGADS measures static disease severity. Participants are asked "Considering all the ways in which your eczema affects you, indicate how well you are doing" and rate their overall well-being based on a 5-point Likert scale from 1 being "Poor" to 5 being "Excellent".

Time frame: Baseline, Week 24

Absolute Change in Skin Pain NRS Score from Baseline at Week 24

The Skin Pain NRS is a two-item measure including an 11-point scale in which participants are asked to rate their skin pain over the prior 24 hours, where 0 is no pain and 10 is the worst imaginable pain.

Time frame: Baseline, Week 24

Absolute Change in ItchyQoL from Baseline at Week 24

The ItchyQoL questionnaire is a PRO measure specifically designed to assess the impact of pruritus (itch) on an individual's quality of life. Both versions of ItchyQoL Frequency and Bother will be assessed in the study. The assessment consists of 22 items for Frequency and 15 items for Bother, covering 3 domains: symptoms, functioning, emotions. Each item utilises a 5-point response scale (1: never; 2: rarely; 3: sometimes; 4: often; 5: all of the time). A total score is calculated by summing individual item responses with higher scores indicating greater impact on health-related quality of life.

Time frame: Baseline, Week 24

Percentage Change in Eczema Area and Severity Index (EASI) from Baseline at Week 24 in Participants with Atopic Dermatitis (AD)

The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease.

Time frame: Baseline, Week 24

Change from Baseline in Patient Global Impression of Severity (PGI-S) at Week 24

Time frame: Baseline, Week 24

Change from Baseline in PGI-S Itch at Week 24

PGI-S is a single-item assessment of perceived symptom or health status severity using a 5-point verbal rating scale ranging from 1 to 5 (no symptoms experienced, mild, moderate, severe, very severe). Participants will be evaluated for PGI-S for itch for overall NE-related health status.

Time frame: Baseline, Week 24

Patient Global Impression of Change (PGI-C) at Week 24

The PGI-C is a single-item assessment of perceived change in a symptom or health status. Change is captured using a 7-point verbal rating scale (much worse, moderately worse, a little worse, no change, a little better, moderately better, and much better).

Time frame: At Week 24

PGI-C Itch at Week 24

Time frame: At Week 24

Clinical Global Impression of Change (CGI-C) at Week 24

CGI-C is a single item assessment of change in participants' condition based on clinician assessment at a given timepoint. Change is captured using a 7-point verbal rating scale (much worse, moderately worse, a little worse, no change, a little improved, moderately improved, much improved).

Time frame: At Week 24

Change from Baseline in Clinical Global Impression of Severity (CGI-S) at Week 24

CGI-S is a single-item assessment of severity of the participants' condition based on clinician assessment at a given timepoint. Change is captured using a 4-point verbal rating scale (none, mild, moderate, severe).

Time frame: Baseline, Week 24

Percentage of Participants with DLQI >=4 at Baseline Achieving DLQI >=4-point Improvement from Baseline at Week 24

Time frame: 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

The IGA is an instrument used to globally rate the severity of a participants.

Time frame: 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

The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity during the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable".

Time frame: 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

Time frame: Baseline, Week 24 up to Week 48

Absolute Change from Baseline in DLQI to Week 48

Time frame: Baseline up to Week 48