LEBRIKIZUMAB for Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- The participant has given their written consent to participate in the trial."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Diagnosis of AD and a history of inadequate topical treatment response as assessed by the clinician."}
• {"criterion_text":"- 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

• {"criterion_text":"- Hypersensitivity to the active substances or to any of the excipients of lebrikizumab"}
• {"criterion_text":"- Patients with pre-existing helminth infections"}
• {"criterion_text":"- Concomitant use of live and live attenuated vaccines"}
• {"criterion_text":"- Pregnant and/or breastfeeding women."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients unable to understand the study’s information and conduct in Swedish or English translations of the material"}

Primary endpoints

• {"endpoint_text":"- The percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 24, the final visit of the study.","definition_or_measurement_approach":"EASI-75 defined as ≥75% reduction from Baseline in EASI score measured at Week 24 (final visit)."}

Secondary endpoints

• {"endpoint_text":"- Alternative clinically evaluated endpoint measures (IGA ≤1 and≥2 point improvement; DLQI≥4 point improvement; NRS ≥4 point improvement);","definition_or_measurement_approach":"Investigator Global Assessment (IGA) improvements, Dermatology Life Quality Index (DLQI) ≥4-point improvement, Numeric Rating Scale (NRS) ≥4-point improvement as clinically evaluated measures."}
• {"endpoint_text":"- Registry-based (EG: SwedAD) PROMS (POEM, MADRS-S, RECAP)","definition_or_measurement_approach":"Patient-reported outcome measures collected via registries (example: SwedAD) including POEM, MADRS-S, and RECAP."}
• {"endpoint_text":"- Skin physiological outcome measures in the form of EIS in all patients and evaporimetry, Epsilon and TiVi in a subgroup","definition_or_measurement_approach":"Skin physiology measured by Electrical Impedance Spectroscopy (EIS) in all patients; evaporimetry, Epsilon, and TiVi measurements in a predefined subgroup."}
• {"endpoint_text":"- NMF and Skin lipid sampling (tape stripping in all and biopsy for ToF-SIMS in an adult subgroup","definition_or_measurement_approach":"Natural Moisturising Factor (NMF) and skin lipid sampling via tape stripping in all participants; additional biopsy for Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) in an adult subgroup."}
• {"endpoint_text":"- Vitamin D status in blood and skin biopsy (adults only)","definition_or_measurement_approach":"Vitamin D levels assessed in blood and in skin biopsy samples (adults only)."}

Sweden

Earliest CTIS Part Ii Submission Date

06-02-2026

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

6

Number Of Sites

4

Number Of Participants

30

Primary sponsor

Full Name

Region Oestergoetland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden