A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

NCT06526182 | Active Not Recruiting Phase 3

• 2 other identifiers: M-17923-342023-508235-31
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 4

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 AD in Part 1 and to describe how similar is the current maintenance dosing regimen of lebrikizumab 250 mg every 4 weeks (Q4W) to the new proposed; lebrikizumab 500 mg every 12 weeks (Q12W), in terms of efficacy, safety, PK, ADA and blood biomarkers.

Conditions

Dermatitis, Atopic; Eczema

Keywords

Dermatitis; Skin Diseases; Skin Diseases, Eczematous; Moderate-to-severe atopic dermatitis

Outcome Measures

Primary Outcomes (3)

• Part 1: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score Less than or Equal to (<=) 7 at Week 24

  The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. The severity of erythema, induration/papulation, excoriation, and lichenification will be assessed by the Investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head/neck, trunk, upper limbs, and lower limbs, and converted to a score of 0 (0%), 1 (0 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) and 6 (90 to 100%).

  At Week 24

• Part 2: Percentage of Participants Achieving EASI 75 at Week 36

  The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. EASI 75 is defined as 75% reduction from baseline in the EASI score.

  At Week 36

• Part 2: Percentage of Participants with an IGA Score of 0 or 1 and a Reduction >=2 Points

  The IGA is an instrument used to globally rate the severity of the participant's AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting (minimal, palpable induration and significant induration).

  From Baseline (Part 1) up to Week 36

Secondary Outcomes (25)

• Part 1: Time to Achieve an EASI Score <= 7

  Baseline up to Week 24

• Part 1: Percentage of Participants Achieving EASI <=5, and EASI <=3 at Week 24

  At Week 24

• Part 1: Percentage of Participants Achieving EASI 75 and EASI 90 at Week 24

  At Week 24

• Part 1: Percentage of Participants with an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction Greater Than or Equal to (>=2) Points at Week 24

  At Week 24

• Part 1: Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) 75, and SCORAD 90 at Week 24

  At Week 24

Study Arms (5)

Part 1: Open label (Lebrikizumab)

EXPERIMENTAL

Participants with moderate-to-severe AD will receive loading doses of lebrikizumab 500 mg SC injection (2 injections) at Day 1 and Week 2 followed by 250 mg (1 injection) every 2 weeks (Q2W) after Week 4 to Week 16 followed by 250 mg (1 injection) every 4 weeks (Q4W) after Week 16 to Week 24.

Biological: Lebrikizumab

Part 2: Open label Run-In Period (Lebrikizumab)

EXPERIMENTAL

Participants who respond to lebrikizumab treatment at Week 24 of Part 1 will continue treatment in Part 2, which includes an 8-week open-label Run-In Period to confirm sustained clinical response. During this period, they will receive lebrikizumab 250 mg SC injection (1 injection) Q4W starting from the Week 24 visit of Part 1.

Biological: Lebrikizumab

Part 2: Double-Blind (Lebrikizumab)

EXPERIMENTAL

At the end of the Run-In Period, participants who demonstrate sustained clinical response will continue treatment in the double-blind period. They will either receive lebrikizumab 250 mg SC injection (1 injection) Q4W or switch to lebrikizumab 500 mg SC injection (2 injections) Q12W for 36 weeks.

Biological: Lebrikizumab

Part 2: Double-Blind (Placebo)

PLACEBO COMPARATOR

At the end of the Run-In Period, participants who demonstrate sustained clinical response will continue treatment in the double-blind period. They will either receive lebrikizumab matching placebo 250 mg SC injection (1 injection) Q4W or switch to lebrikizumab matching placebo 500 mg SC injection (2 injections) Q12W for 36 weeks.

Other: Placebo

Part 2: Open label Escape Arm (Lebrikizumab)

EXPERIMENTAL

Participants who do not maintain at least a 50% reduction in EASI from baseline (EASI 50) during Double-Blind Period will enter an Escape Arm, in which participants are treated with open label lebrikizumab 250 mg SC injection Q4W. Study drug treatment will be discontinued in participants entering the Escape Arm who do not maintain an EASI 50 response.

Biological: Lebrikizumab

Interventions

Lebrikizumab BIOLOGICAL

Lebrikizumab solution for injection administered subcutaneously.

Part 1: Open label (Lebrikizumab); Part 2: Double-Blind (Lebrikizumab); Part 2: Open label Escape Arm (Lebrikizumab); Part 2: Open label Run-In Period (Lebrikizumab)

Placebo OTHER

Lebrikizumab Matching placebo solution for injection administered subcutaneously.

Part 2: Double-Blind (Placebo)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1:
• Adults and adolescents (aged greater than or equal to \[\>=\] 12 to less than \[\<\] 18 at the time of informed consent form \[ICF\]/informed assent form \[IAF\] signature and weighing 40 \>= kilograms \[kg\]) who are candidates for systemic AD therapy.
• Chronic AD (according to Hanifin and Rajka Criteria (Hanifin 1980)) 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 Day 1/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).
• Part 2:
• Demonstrate clinical response to treatment at Week 24 of Part 1, defined as achieving EASI 75 or IGA 0/1 without the use of high-potency TCS within the prior 4 weeks or systemic corticosteroids at any time post baseline.

You may not qualify if:

• 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 (Sampson 2006).
• Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg, comorbid 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 before or during screening or development of these infections before Day 1/Baseline:
• Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment, as per the Investigator's opinion);
• Opportunistic (as defined by Winthrop et al. (Winthrop 2015))
• Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);
• Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis).
• Known current or chronic infection with any hepatitis virus.
• Known liver cirrhosis and/or chronic hepatitis of any aetiology.
• Known active endoparasitic infection or at high risk of these infections.
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., 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 participants participation in the study, per the Investigator's judgement.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (4)

Hospital General Universitario Dr. Balmis

Alicante, Spain

Location

Hospital del Mar - Parc de Salut Mar

Barcelona, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, Spain

Location

Consorci Hospital General Universitari de València

Valencia, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Dermatitis; Skin Diseases; Skin Diseases, Eczematous

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 and Part 2 (Run-In Period): Open label; Part 2: Randomized and Double-Blind.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): April 25, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)