Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

NCT ID: NCT05990725

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2025-06-23

Brief Summary

The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe atopic dermatitis (AD).

Conditions

Atopic Dermatitis; Eczema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lebrikizumab

Participants will receive loading doses of lebrikizumab 500 milligrams (mg) subcutaneous (SC) injection at Day 1 and Week 2 followed by lebrikizumab 250 mg SC injection, every two weeks (Q2W) from Week 4 to Week 16. At Week 16, the dosing frequency will be reduced to every 4 weeks (Q4W) and will receive lebrikizumab 250 mg SC injection for up to Week 24, last dose of study medication is administered at Week 20.

Group Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: BIOLOGICAL

Lebrikizumab solution for injection administered subcutaneously.

Interventions

Lebrikizumab

Lebrikizumab solution for injection administered subcutaneously.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adults and adolescents (aged >=12 to less than [<] 18 years at the time of informed consent form (ICF)/informed assent form (IAF) signature and weighing >=40 kg) who are candidates for systemic AD therapy.
• Chronic AD that has been present for >=1 year before the Screening visit.
• EASI score >=12 at the Day 1/Baseline Visit.
• IGA score >=3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit.
• >=10% BSA of AD involvement at the Day 1/Baseline visit.
• History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
• Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4 of 7 days before Day 1/Baseline.
• Willing and able to comply with all clinic visits and study-related procedures and questionnaires.
• For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or to use a highly effective contraceptive method during the treatment period and for at least 4 weeks or 1 menstrual period after the last dose of lebrikizumab.
• Participant must provide signed ICF. Adolescent participants must also provide separate informed assent to enroll in the study and sign and date either a separate IAF or the ICF signed by the parent/legal guardian (as appropriate based on local regulations and requirements).

Exclusion Criteria

• Prior treatment at any time with tralokinumab, lebrikizumab, or an oral JAK inhibitor.
• Intention to use any concomitant medication or therapy 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 bursts of oral corticosteroids, example, co-morbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5 score >=1.5 or a history of >=2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalisation for >24 hours).
• Occurrence of the following types of infection within 3 months of Screening or develop any of these infections before Day 1/Baseline:

1. Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment, as per the Investigator's opinion);

2. Opportunistic

3. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);

4. Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis).

• Known current or chronic infection with hepatitis B virus.
• Known liver cirrhosis and/or chronic hepatitis of any aetiology.
• Known active endoparasitic infections or at high risk of these infections.
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections (example, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgement.
• History of human immunodeficiency virus (HIV) infection or known positive HIV serology.
• Any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit that would jeopardise the patient's participation in the study, per the Investigator's judgement.
• Presence of skin comorbidities that may interfere with study assessments.
• History of malignancy, including mycosis fungoides, within 5 years before the Screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
• Severe concomitant illness(es) that in the Investigator's judgement would adversely affect the participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study participant because of his/her participation in this clinical trial, may make participation unreliable, or may interfere with study assessments.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 34

Augsburg, , Germany

Site 9

Berlin, , Germany

Site 29

Bonn, , Germany

Site 27

Dresden, , Germany

Site 28

Düsseldorf, , Germany

Site 11

Erlangen, , Germany

Site 37

Frankfurt, , Germany

Site 32

Freiburg im Breisgau, , Germany

Site 5

Göttingen, , Germany

Site 15

Hamburg, , Germany

Site 3

Hamburg, , Germany

Site 8

Hamburg, , Germany

Site 23

Heidelberg, , Germany

Site 1

Kiel, , Germany

Site 19

Langenau, , Germany

Site 10

Lübeck, , Germany

Site 26

Mainz, , Germany

Site 6

Mannheim, , Germany

Site 36

Marburg, , Germany

Site 13

München, , Germany

Site 17

München, , Germany

Site 33

München, , Germany

Site 4

Münster, , Germany

Site 12

Oberhausen, , Germany

Site 22

Oldenburg, , Germany

Site 2

Potsdam, , Germany

Site 30

Regensburg, , Germany

Site 7

Rostock, , Germany

Site 18

Tübingen, , Germany

Site 35

Bergen op Zoom, , Netherlands

Site 41

Utrecht, , Netherlands

Site 38

Leeds, , United Kingdom

Site 14

York, , United Kingdom

Countries

Germany; Netherlands; United Kingdom

Other Identifiers

2023-505558-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M-17923-33

Identifier Type: -

Identifier Source: org_study_id