Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis (ADhope)

Almirall

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis; Eczema

Treatments: Biological: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05990725

2023-505558-16 (EudraCT Number)

M-17923-33

Details and patient eligibility

About

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).

Enrollment: 240 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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 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).

• Have had any 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 current infection with hepatitis C virus (that is, positive for hepatitis C RNA).

• Known liver cirrhosis and/or chronic hepatitis of any aetiology.

• Diagnosed 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.

• In the Investigator's opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit.

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

Lebrikizumab

Experimental group

Description:

Participants will receive lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection, once every two weeks (Q2W) on Day 1 for up to Week 16. A loading dose of lebrikizumab 500 mg (2 injections) SC will be administered on Day 1 and at Week 2, further followed by lebrikizumab 250 mg (1 injection), SC, once every four weeks (Q4W) after Week 16 for up to Week 24.

Treatment:

Biological: Lebrikizumab