A Study of Lebrikizumab in Adults With Nummular Eczema

NCT07542483 | Not Yet Recruiting Phase 3

• 2 other identifiers: M-27501-302025-522403-17-00
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nummular Eczema

Keywords

Nummular Eczema; Dermatitis; Skin Diseases; Lebrikizumab

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 24

Secondary Outcomes (19)

• 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

• 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

Study Arms (4)

Placebo-controlled Period: Lebrikizumab

EXPERIMENTAL

Drug: Lebrikizumab

Placebo-controlled Period: Placebo

PLACEBO COMPARATOR

Other: Placebo

Blinded Extension Period: Lebrikizumab

EXPERIMENTAL

Drug: Lebrikizumab

Blinded Extension Period: Lebrikizumab + Placebo

EXPERIMENTAL

Drug: Lebrikizumab; Other: Placebo

Interventions

Lebrikizumab DRUG

Lebrikizumab SC injection.

Blinded Extension Period: Lebrikizumab; Blinded Extension Period: Lebrikizumab + Placebo; Placebo-controlled Period: Lebrikizumab

Placebo OTHER

Matching placebo SC injection.

Blinded Extension Period: Lebrikizumab + Placebo; Placebo-controlled Period: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead

MeSH Terms

Conditions

Dermatitis; Skin Diseases

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Central Study Contacts

Estrella Garcia

CONTACT

gco@almirall.com

Natalia Calderón

CONTACT

gco@almirall.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of a placebo-controlled period followed by a blinded extension period.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share