A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine (ADvantage)

Almirall

Status and phase: Completed; Phase 3

Conditions: Dermatitis, Atopic; Eczema

Treatments: Biological: Lebrikizumab; Drug: Lebrikizumab-matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05149313

M-17923-30

2021-002967-23 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.

Enrollment: 331 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults and adolescents (aged greater than or equal to (>=) 12 to <18 years at the time of Informed Consent Form (ICF)/Informed Assent Form (IAF) and weighing >=40 kilograms).
• Chronic AD that has been present for >=1 year before the Screening visit.
• EASI score >=16 at the Baseline Visit.
• IGA score >=3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit.
• >=10% BSA of AD involvement at the Baseline visit.
• Inadequate response to existing topical medications
• Failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine
• Signed ICF (and informed assent for adolescents as required)

Exclusion criteria

• Treatment with TCS within 1 week before the Baseline visit.
• Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit.
• Treatment with interleukin 4 (IL-4) or interleukin 13 (IL-13) antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients
• Treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the Baseline visit
• Uncontrolled chronic disease that might require bursts of oral corticosteroids
• Serious, opportunistic, chronic or recurring infections within 3 months of Screening or before randomization
• Current or chronic infection with hepatitis B virus, current infection with hepatitis C virus, known liver cirrhosis and/or chronic hepatitis of any etiology
• Known or suspected history of immunosuppression, history of HIV infection or positive HIV serology at Screening
• Any clinically significant laboratory test results obtained at the Screening visit
• Presence of skin comorbidities that may interfere with study assessments
• Have had an important side effect to TCS that would prevent further use.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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331 participants in 2 patient groups, including a placebo group

Lebrikizumab

Experimental group

Description:

Lebrikizumab administered subcutaneously (SC), participants will receive 2 injections of lebrikizumab 250 mg at Baseline and Week 2, followed by 1 injection of lebrikizumab 250 milligram (mg) once every two weeks (Q2W) in the induction period up to week 16. Participants who received lebrikizumab 250 mg Q2W during the Induction Period will continue to receive lebrikizumab 250 mg Q2W during the Maintenance Period. In order to maintain the double blind, participants from the lebrikizumab 250 mg Q2W arm will be administered a second injection of blinded placebo during Week 16 and Week 18. From Week 20 up to Week 52, all participants will receive 1 injection of lebrikizumab 250 mg Q2W in Open-label maintenance period.

Treatment:

Biological: Lebrikizumab

Lebrikizumab-matching Placebo

Placebo Comparator group

Description:

Lebrikizumab-matching Placebo administered SC, 250 mg dose, Q2W in the induction period for 16 weeks. Participants will receive 2 injections of lebrikizumab 250 mg at Week 16 and Week 18 followed by 1 injection of lebrikizumab 250 mg Q2W from Week 20 up to Week 52 in Open-label maintenance period.

Treatment:

Drug: Lebrikizumab-matching Placebo