A Phase 3b, Open-label Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

Almirall, S.A.33 sites in 3 countries240 target enrollmentNovember 20, 2023

ConditionsAtopic Dermatitis Eczema

InterventionsLebrikizumab

Overview

Phase: Phase 3
Intervention: Lebrikizumab
Conditions: Atopic Dermatitis
Sponsor: Almirall, S.A.
Enrollment: 240
Locations: 33
Primary Endpoint: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score Less Than or Equal to (<=) 7 at Week 24
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 20, 2023

End Date

June 23, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Almirall, S.A.

Responsible Party

Sponsor

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:
•Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment, as per the Investigator's opinion);
•Opportunistic
•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 hepatitis B virus.

Arms & Interventions

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.

Intervention: Lebrikizumab

Outcomes

Primary Outcomes

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score Less Than or Equal to (<=) 7 at Week 24

Time Frame: 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%).

Secondary Outcomes

Percentage of Participants Achieving EASI Score <=7, EASI <=5, and EASI <=3(Baseline up to Week 24)
Percentage of Participants Achieving EASI 75 and EASI 90(Baseline up to Week 24)
Percentage of Participants with an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction Greater Than or Equal to (>=2) Points(Baseline up to Week 24)
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) 75 and SCORAD 90(Baseline up to Week 24)
Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)(Baseline up to Week 24)
Percentage of Participants With Pruritus Numerical Rating Scale (NRS) >=4 at Baseline Achieving >=4-Point Improvement in Pruritus NRS(Baseline up to Week 24)
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) 0-1(Baseline up to Week 24)
Percentage of Participants With DLQI >=4 at Baseline Achieving >=4-Point Improvement in DLQI(Baseline up to Week 24)
Percentage of Participants Achieving Children Dermatology Life Quality Index (cDLQI) 0-1(Baseline up to Week 24)
Percentage of Participants With cDLQI >=6 at Baseline Achieving >=6-Point Improvement in cDLQI(Baseline up to Week 24)
Percentage of Participants With a Sleep-Loss Scale of >=2 Points at Baseline Who Achieve at least 2-point Reduction Using PRO(Baseline up to Week 24)
Percentage of Participants With Patient-Oriented Eczema Measure (POEM) >=4 at Baseline Achieving >=4-Point Improvement in POEM(Baseline up to Week 24)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related AEs, AEs Leading to Study Treatment Discontinuation, and Adverse Events of Special Interest (AESIs)(Baseline up to follow-up (Week 28))