Effectiveness and Safety of Lebrikizumab Treatment in Adu... | NCT05990725

ID	Type	Description	Link
2023-505558-16	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Lebrikizumab	Experimental	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.	Biological: Lebrikizumab

Name	Type	Description	Arm Group Labels	Other Names
Lebrikizumab	Biological	Lebrikizumab solution for injection administered subcutaneously.	Lebrikizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving EASI Score <=7, EASI <=5, and EASI <=3	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%).

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
Site 34		Augsburg			Germany
Site 9

ID	Term
D003876	Dermatitis, Atopic
D004485	Eczema
D003872	Dermatitis
D012871	Skin Diseases

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases