An interventional, Open-label Study to Evaluate the effect of lebrikizumab on eczema and Skin Barrier Function parameters in lesional and non-lesional skin in Adults and Adolescents with Moderate to Severe Atopic Dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Oestergoetland

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

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

Decision date (initial)

2026-02-12

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: Efficacy, Therapy

The primary objective of this trial is to confirm the effectiveness of lebrikizumab in improving eczema in patients with moderate-to-severe AD.

Secondary objectives 1

1. The secondary objective is to evaluate the effectiveness of lebrikizumab in improving skin barrier function in patients with moderate-to-severe AD and to compare the performance of the primary outcome measure, EASI, with the performance of other outcome measures in regard to reproducibility, objectivity, onset timing and utility in early prediction of response.

Conditions and MedDRA coding

Atopic dermatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. The participant has given their written consent to participate in the trial.
2. Adults (aged 18-64) and adolescents (aged ≥12 to <18 years at the time of ICF/informed assent form (IAF) signature and weighing ≥40 kg) who are candidates for systemic AD therapy.
3. Diagnosis of AD and a history of inadequate topical treatment response as assessed by the clinician.
4. Adolescent participants (aged ≥12 to <18 years) must have their written informed consent signed by the parent/legal guardian. Adolescent participants from 15 years also need to give their own written consent to participate in the trial.

Exclusion criteria 6

1. Hypersensitivity to the active substances or to any of the excipients of lebrikizumab
2. Patients with pre-existing helminth infections
3. Concomitant use of live and live attenuated vaccines
4. Pregnant and/or breastfeeding women.
5. Patients unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study
6. Patients unable to understand the study’s information and conduct in Swedish or English translations of the material

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 24, the final visit of the study.

Secondary endpoints 5

1. Alternative clinically evaluated endpoint measures (IGA ≤1 and≥2 point improvement; DLQI≥4 point improvement; NRS ≥4 point improvement);
2. Registry-based (EG: SwedAD) PROMS (POEM, MADRS-S, RECAP)
3. Skin physiological outcome measures in the form of EIS in all patients and evaporimetry, Epsilon and TiVi in a subgroup
4. NMF and Skin lipid sampling (tape stripping in all and biopsy for ToF-SIMS in an adult subgroup
5. Vitamin D status in blood and skin biopsy (adults only)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oestergoetland

Sponsor organisation

Region Oestergoetland

Address

Universitetssjukhuset I

City

Linkoping

Postcode

58185

Country

Sweden

Scientific contact point

Organisation

Region Oestergoetland

Contact name

Sponsor's Representative

Public contact point

Organisation

Region Oestergoetland

Contact name

Sponsor's Representative

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

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

Documents 12 files

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

Application history

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