Clinical trial NCT05990725: Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Eczema
Keywords: Dermatitis
Skin Diseases
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score Less Than or Equal to (<=) 7 at Week 24
timeFrame: At Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving EASI Score <=7, EASI <=5, and EASI <=3
timeFrame: Baseline up to Week 24
measure: Percentage of Participants Achieving EASI 75 and EASI 90
timeFrame: Baseline up to Week 24
measure: Percentage of Participants with an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction Greater Than or Equal to (>=2) Points
timeFrame: Baseline up to Week 24
measure: Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) 75 and SCORAD 90
timeFrame: Baseline up to Week 24
measure: Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
timeFrame: Baseline up to Week 24
measure: Percentage of Participants With Pruritus Numerical Rating Scale (NRS) >=4 at Baseline Achieving >=4-Point Improvement in Pruritus NRS
timeFrame: Baseline up to Week 24
measure: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) 0-1
timeFrame: Baseline up to Week 24
measure: Percentage of Participants With DLQI >=4 at Baseline Achieving >=4-Point Improvement in DLQI
timeFrame: Baseline up to Week 24
measure: Percentage of Participants Achieving Children Dermatology Life Quality Index (cDLQI) 0-1
timeFrame: Baseline up to Week 24
measure: Percentage of Participants With cDLQI >=6 at Baseline Achieving >=6-Point Improvement in cDLQI
timeFrame: Baseline up to Week 24
measure: Percentage of Participants With a Sleep-Loss Scale of >=2 Points at Baseline Who Achieve at least 2-point Reduction Using PRO
timeFrame: Baseline up to Week 24
measure: Percentage of Participants With Patient-Oriented Eczema Measure (POEM) >=4 at Baseline Achieving >=4-Point Improvement in POEM
timeFrame: Baseline up to Week 24
measure: 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)
timeFrame: Baseline up to follow-up (Week 28)
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Site 34
city: Berlin
country: Germany
facility: Site 9
city: Bonn
country: Germany
facility: Site 29
city: Dresden
country: Germany
facility: Site 27
city: Düsseldorf
country: Germany
facility: Site 28
city: Erlangen
country: Germany
facility: Site 11
city: Frankfurt
country: Germany
facility: Site 37
city: Freiburg
country: Germany
facility: Site 32
city: Göttingen
country: Germany
facility: Site 5
city: Hamburg
country: Germany
facility: Site 15
city: Hamburg
country: Germany
facility: Site 3
city: Hamburg
country: Germany
facility: Site 8
city: Heidelberg
country: Germany
facility: Site 23
city: Kiel
country: Germany
facility: Site 1
city: Langenau
country: Germany
facility: Site 19
city: Lübeck
country: Germany
facility: Site 10
city: Mainz
country: Germany
facility: Site 26
city: Mannheim
country: Germany
facility: Site 6
city: Marburg
country: Germany
facility: Site 36
city: München
country: Germany
facility: Site 13
city: München
country: Germany
facility: Site 17
city: München
country: Germany
facility: Site 33
city: Münster
country: Germany
facility: Site 4
city: Oberhausen
country: Germany
facility: Site 12
city: Oldenburg
country: Germany
facility: Site 22
city: Potsdam
country: Germany
facility: Site 2
city: Regensburg
country: Germany
facility: Site 30
city: Rostock
country: Germany
facility: Site 7
city: Tübingen
country: Germany
facility: Site 18
city: Bergen Op Zoom
country: Netherlands
facility: Site 35
city: Utrecht
country: Netherlands
facility: Site 41
city: Leeds
country: United Kingdom
facility: Site 38
city: York
country: United Kingdom
facility: Site 14
Study officials:
References: