Phase 3 Efficacy and Safety of Lebrikizumab in Adults With Nummular Eczema (LUMINE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Almirall S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

10 Apr 2026 → ongoing

Decision date (initial)

2026-03-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy, Pharmacokinetic

To evaluate the efficacy of lebrikizumab compared to placebo up to Week 24 in participants with NE who are not adequately controlled with TCS or when this treatment is not medically advisable.

Secondary objectives 1

1. To evaluate the safety of lebrikizumab in participants with NE who are not adequately controlled with TCS or when this treatment is not medically advisable

Conditions and MedDRA coding

Nummular Dermatitis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1. 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.
2. 2. Adult (aged 18 years or more at the time of Screening) diagnosed clinically with NE, as confirmed by the Investigator.
3. 3. Presence of NE signs and/or symptoms for at least 6 months prior to Screening.

Exclusion criteria 7

1. 1. 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).
2. 2. 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).
3. 3. 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.
4. 4. History of anaphylaxis as defined by the Sampson criteria.
5. 5. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
6. 6. History of sensitivity and/or allergy to any of the ingredients of the trial medication.
7. 7. Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Percentage of participants achieving endpoint reduction from baseline at Week 24.

Secondary endpoints 2

1. 1. Percentage of participants with Pruritus NRS ≥4 at baseline achieving a ≥4-point improvement in Pruritus NRS score from baseline at Week 24
2. 2. Absolute change from baseline in DLQI to Week 24.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Almirall S.A.

Sponsor organisation

Almirall S.A.

Address

Ronda General Mitre 151

City

Barcelona

Postcode

08022

Country

Spain

Scientific contact point

Organisation

Almirall S.A.

Contact name

Regulatory Strategy

Public contact point

Organisation

Almirall S.A.

Contact name

Almirall S.A

Third parties 15

Locations

5 EU/EEA countries · 57 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 78 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications