A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermat… (NCT06526182) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
Spain520 participantsStarted 2024-07-03
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
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.
✕
What they're measuring
1
Part 1: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score Less than or Equal to (<=) 7 at Week 24
Timeframe: At Week 24
2
Part 2: Percentage of Participants Achieving EASI 75 at Week 36
Timeframe: At Week 36
3
Part 2: Percentage of Participants with an IGA Score of 0 or 1 and a Reduction >=2 Points
. 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);