Lebrikizumab for Eczema
(ADorable-1 Trial)
Recruiting in Palo Alto (17 mi)
+119 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Eli Lilly and Company
Must not be taking: Dupilumab
Disqualifiers: Recent clinical study, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have used certain investigational drugs or Dupilumab recently. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Lebrikizumab for eczema?
Research shows that Lebrikizumab, a drug targeting a protein called interleukin-13, is effective in treating moderate-to-severe eczema. In clinical trials, many patients experienced significant improvements in their skin condition and itchiness, with a good safety profile.
12345Is lebrikizumab safe for treating eczema?
Lebrikizumab has been shown to be generally safe in clinical trials for moderate-to-severe eczema, with most patients experiencing no significant side effects. Common mild side effects included conjunctivitis (eye inflammation), nasopharyngitis (cold-like symptoms), and headache.
12345What makes the drug Lebrikizumab unique for treating eczema?
Lebrikizumab is unique because it is a monoclonal antibody that specifically targets interleukin-13 (IL-13), a protein involved in the inflammation and skin barrier dysfunction seen in eczema. This targeted approach helps reduce symptoms like itching and skin lesions, offering a promising option for those with moderate-to-severe atopic dermatitis.
12345Eligibility Criteria
This trial is for kids aged 6 months to less than 18 years with moderate-to-severe atopic dermatitis (eczema). They must have had eczema for a certain time and meet specific severity scores. Kids can't join if they've used experimental skin treatments recently, been in another study, or received certain vaccines or drugs too close to the start of this trial.Inclusion Criteria
Your IGA score is 3 or higher during the screening and baseline.
You have a skin condition with an EASI score of 16 or higher at the screening and baseline.
I have been diagnosed with atopic dermatitis for the required time based on my age.
+1 more
Exclusion Criteria
I have not taken Dupilumab in the last 8 weeks.
I received a BCG vaccine or treatment less than 4 weeks ago.
I haven't taken any experimental drugs recently.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive lebrikizumab or placebo by subcutaneous injections with a topical corticosteroid, dosing based on weight
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests Lebrikizumab's effects on young patients with eczema compared to a placebo, alongside standard eczema creams. It aims to see how safe it is and how their bodies handle it.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lebrikizumab (Cohort 2)Experimental Treatment2 Interventions
Participants who are 6 months to \<6 years of age, 2 years to \<6 years of age or 6 months to \<2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS.
Dosing will be based on weight.
Group II: Lebrikizumab (Cohort 1)Experimental Treatment2 Interventions
Participants who are 6 years to \<18 years of age, 12 years to \<18 years of age who weigh \<40 kilogram (kg) or 6 years to \<12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS).
Dosing will be based on weight.
Group III: PlaceboPlacebo Group2 Interventions
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
Lebrikizumab is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Ebglyss for:
- Moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg
🇺🇸 Approved in United States as Ebglyss for:
- Moderate-to-severe atopic dermatitis in adults and children 12 years and older who weigh at least 88 pounds (40 kg)
🇨🇦 Approved in Canada as Ebglyss for:
- Moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Integrative Skin Science and ResearchSacramento, CA
Dermatology Research AssociatesLos Angeles, CA
Alberta Dermasurgery CentreEdmonton, Canada
DermEdge ResearchMississauga, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Eli Lilly and CompanyLead Sponsor
Dermira, Inc.Industry Sponsor
References
Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study. [2023]Atopic dermatitis (AD) is a chronic inflammatory skin disorder with limited treatment options for adolescents with moderate-to-severe disease. Lebrikizumab, a monoclonal antibody targeting interleukin (IL)-13, demonstrated clinical benefit in previous Phase 3 trials: ADvocate1 (NCT04146363), ADvocate2 (NCT04178967), and ADhere (NCT04250337). We report 52-week safety and efficacy outcomes from ADore (NCT04250350), a Phase 3, open-label study of lebrikizumab in adolescent patients with moderate-to-severe AD. The primary endpoint was to describe the proportion of patients who discontinued from study treatment because of adverse events (AEs) through the last treatment visit.
The role of lebrikizumab in the treatment of atopic dermatitis in the adult population. [2023]Although there are many atopic dermatitis (AD) treatments, finding a long-term medication with minimal side effects can be difficult. This review characterizes lebrikizumab as AD treatment in adults. A literature search was conducted to examine lebrikizumab's role in treating moderate to severe AD. In a phase III trial, 74% of adults with AD treated with lebrikizumab 250 mg every 4 weeks achieved an Investigator Global Assessment of 0/1, 79% achieved Eczema Area and Severity Index 75 and 79% experienced improvements in pruritus numeric rating scale scores relative to placebo. Common adverse effects in the ADvocate1 and ADvocate2 trials were conjunctivitis (7 and 8%, respectively), nasopharyngitis (4 and 5%, respectively) and headache (3 and 5%, respectively). Results from clinical trials suggest that lebrikizumab may be a viable alternative for AD management.
Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). [2023]Lebrikizumab (LEB), a high-affinity monoclonal antibody targeting interleukin (IL)-13, demonstrated efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) during 16 weeks of monotherapy in a phase 2b trial, and two 52-week phase 3 trials.
Lebrikizumab for the Treatment of Moderate-to-Severe Atopic Dermatitis. [2023]Atopic dermatitis (AD) is a common, heterogeneous, inflammatory skin disorder characterized by chronic or relapsing eczematous lesions with intense pruritus and discomfort. Affected patients often experience significant impairment in their quality of life, and the treatment of moderate-to-severe AD forms remains challenging. In the past few decades, increasing knowledge on the AD pathogenesis has driven the development of novel targeted therapies. Interleukin (IL)-13 plays a central and pleiotropic role in AD pathogenesis, contributing directly or indirectly to epidermal barrier disfunction, type-2 inflammation, dysbiosis, fibrosis, and itch response. For this reason, agents selectively targeting IL-13, such as lebrikizumab, emerged as a potential therapy for AD. This article reviews the current evidence about lebrikizumab in the management of AD. The phase II and phase III trials seem to corroborate efficacy of lebrikizumab in the treatment of moderate-to-severe AD, as shown by significant improvement of Eczema Area and Severity Index, body surface area, and pruritus scores. Also, lebrikizumab demonstrated favorable safety and tolerability profiles, with the majority of patients experiencing no significant adverse events. Lebrikizumab seems to be a promising emerging targeted biological agent for patients with moderate-to-severe AD. More data on the long-term efficacy and safety, head-to-head comparisons with other agents, and real-world evidence will help to clarify its place in therapy in AD.
The efficacy and safety of lebrikizumab monotherapy for the management of moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. [2023]Atopic dermatitis (AD) is a chronically relapsing disease. Few biologics are approved for moderate-to-severe AD, and novel interventions are emerging. We aimed to evaluate the safety and efficacy of lebrikizumab, an IL-13 immunomodulator, as monotherapy vs. placebo in treating moderate-to-severe AD.