2024-519811-32-00
Not yet recruiting
Phase 4
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
Region Oestergoetland4 sites in 1 country30 target enrollmentStarted: February 12, 2026Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Region Oestergoetland
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- The percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 24, the final visit of the study.
Overview
Brief Summary
The primary objective of this trial is to confirm the effectiveness of lebrikizumab in improving eczema in patients with moderate-to-severe AD.
Eligibility Criteria
- Ages
- 0 years to 64 years (0-17 Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The participant has given their written consent to participate in the trial.
- •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.
- •Diagnosis of AD and a history of inadequate topical treatment response as assessed by the clinician.
- •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
- •Hypersensitivity to the active substances or to any of the excipients of lebrikizumab
- •Patients with pre-existing helminth infections
- •Concomitant use of live and live attenuated vaccines
- •Pregnant and/or breastfeeding women.
- •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
- •Patients unable to understand the study’s information and conduct in Swedish or English translations of the material
Outcomes
Primary Outcomes
The percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 24, the final visit of the study.
The percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 24, the final visit of the study.
Secondary Outcomes
- Alternative clinically evaluated endpoint measures (IGA ≤1 and≥2 point improvement; DLQI≥4 point improvement; NRS ≥4 point improvement);
- Registry-based (EG: SwedAD) PROMS (POEM, MADRS-S, RECAP)
- Vitamin D status in blood and skin biopsy (adults only)
- Skin physiological outcome measures in the form of EIS in all patients and evaporimetry, Epsilon and TiVi in a subgroup
- NMF and Skin lipid sampling (tape stripping in all and biopsy for ToF-SIMS in an adult subgroup
Investigators
Sponsor's Representative
Scientific
Region Oestergoetland
Study Sites (4)
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