A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Lebrikizumab; Drug: Topical Corticosteroid

Study type: Interventional

Funder types: Industry

Identifiers

NCT06280716

J2T-MC-KGBW (Other Identifier)

18817

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks.

Enrollment: 430 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have chronic AD that has been present for ≥1 year before the screening period or have chronic eczema and meet the AAD criteria.

• Have moderate-to-severe AD, including all of the following at the baseline: EASI score ≥16,IGA score ≥3 (scale of 0 to 4) , ≥10% BSA of AD involvement.

• Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:

  1. Inability to achieve good disease control, defined as mild disease or better after use of at least a medium-potency TCS for at least 4 weeks, or for the maximum duration recommended by the product prescribing information, whichever is shorter. TCS may be used with or without TCIs and/or topical Janus kinase (JAK) inhibitors.
  2. Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, MTX, azathioprine, and MMF, will also be considered as surrogates for having inadequate response to topical therapy.

• Adolescents body weight must be ≥40 kg at baseline.

• Males may participate in this trial and comply with specific local government study requirements. Females of childbearing potential and females not of childbearing potential may participate in this trial.

Exclusion criteria

• Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.

• Have a history of anaphylaxis or uncontrolled chronic disease that might require bursts of oral corticosteroids.

• Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment.

• Have had Serious, Opportunistic, Chronic and Recurring infection within 3 months prior to the screening or develops any of these infections before the randomization.

• Have active tuberculosis (TB) or latent tuberculosis infection (LTBI) that has not been treated with a complete course of appropriate therapy.

• Have a current infection with HBV, HCV, human immunodeficiency virus (HIV) infection.

• Have presence of skin comorbidities that may interfere with study assessments.

• Have a diagnosis or history of malignant disease within 5 years before screening, with the following exceptions:

  1. basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, and
  2. cervical carcinoma in situ, with no evidence of recurrence within 5 years before screening visit.

• Pregnant or breastfeeding women or women planning to become pregnant or breastfeed during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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430 participants in 5 patient groups, including a placebo group

Lebrikizumab every 2 weeks (Q2W)

Experimental group

Description:

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only lebrikizumab and combo cohort where lebrikizumab is in combination with TCS treatment.

Treatment:

Drug: Topical Corticosteroid

Drug: Lebrikizumab

Lebrikizumab every 4 weeks (Q4W)

Experimental group

Description:

Maintenance Period (Week 16-Week 52): Treatment from Week 16 to Week 52 is based on re-randomization of responders (from lebrikizumab Q2W arm) in the Induction Period. Participants re-randomized to the Lebrikizumab Q4W arm receive one lebrikizumab injection Q4W from Week 16 until Week 48.

Treatment:

Drug: Lebrikizumab

Lebrikizumab every 8 weeks (Q8W)

Experimental group

Description:

Maintenance Period (Week 16-Week 52): Treatment from Week 16 to Week 52 is based on re-randomization of responders (from lebrikizumab Q2W arm) in the Induction Period. Participants re-randomized to Lebrikizumab Q8W arm receive one lebrikizumab injection Q8W, with one placebo injection 4 weeks after each lebikizumab injection from Week 16 until Week 48.

Treatment:

Drug: Lebrikizumab

Escape Arm (Lebrikizumab Q2W)

Experimental group

Description:

Maintenance Period (Week 16-Week 50): Participants who require rescue treatment for atopic dermatitis (AD) during the Induction Period, or are non-responders at Week 16, will be eligible for treatment in an Escape Arm where participants will receive open label lebrikizumab Q2W from Week 16 through Week 50. In addition, participants who do not maintain an acceptable response during the Maintenance Period (have an EASI score \<50% of baseline), will be eligible for the Escape Arm.

Treatment:

Drug: Lebrikizumab

Placebo

Placebo Comparator group

Description:

Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only Placebo and combo cohort where Placebo is given in combination with topical corticosteroid (TCS) treatment. Maintenance Period (Week 16-Week 52): Participants of responders at Week 16 will receive single injection of placebo every 4 weeks (Q4W) from Week 16 until Week 48.

Treatment:

Drug: Topical Corticosteroid

Drug: Placebo