What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include biologic agents like lebrikizumab (IL-13 inhibition), dupilumab (IL-4Rα inhibition), and other systemic therapies. Known side effects of these treatments can include injection site reactions, conjunctivitis, nasopharyngitis, and upper respiratory tract infections. Additionally, some patients may experience headaches and increased risk of certain infections. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including biologics that target specific pathways involved in the disease. Dupilumab, an IL-4 and IL-13 inhibitor, was one of the first biologics approved for moderate-to-severe atopic dermatitis. Other treatments include topical corticosteroids, calcineurin inhibitors like tacrolimus and pimecrolimus, and newer JAK inhibitors such as abrocitinib and upadacitinib. These treatments aim to reduce inflammation and manage symptoms effectively.

What other types of research exist?

Promising novel alternatives to Lebrikizumab for Atopic Dermatitis patients include Dupilumab (IL-4 and IL-13 inhibition), Tralokinumab (IL-13 inhibition), and JAK inhibitors like Upadacitinib and Abrocitinib. These treatments have shown efficacy and safety in clinical trials and are considered effective options for managing moderate-to-severe AD.

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Monoclonal Antibodies

Lebrikizumab for Eczema (ADmirable Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adolescents body weight must be ≥40 kg at baseline.

Have ≥10% body surface area (BSA) of AD involvement at baseline

Must not have

Have known liver cirrhosis and/or chronic hepatitis of any etiology.

Have uncontrolled asthma that might require bursts of oral or systemic corticosteroids, or required the following due to ≥1 exacerbations within 12 months before baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing lebrikizumab, a medication that reduces inflammation, in adolescents and adults with severe eczema and skin of color. The goal is to see if it is safe and effective for these patients.

Who is the study for?

This trial is for adults and adolescents (12 years and older) with moderate-to-severe atopic dermatitis, specifically those with skin of color (Fitzpatrick phototype IV-VI). Participants should have a history of inadequate response to topical treatments. Women must use effective contraception or remain abstinent, while men's requirements vary by location.

What is being tested?

The study tests the safety and effectiveness of Lebrikizumab in treating atopic dermatitis among individuals with darker skin tones. It aims to see if this medication can improve their condition when other treatments haven't worked well enough.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions similar to other medications for atopic dermatitis such as redness, itching or burning at the injection site, headache, cold symptoms, eye inflammation and possible immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is at least 40 kg.

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At least 10% of my skin is affected by my condition.

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I am 12 years old or older and can consent to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have liver cirrhosis or chronic hepatitis.

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My asthma is uncontrolled and I've needed steroids or treatment for flare-ups in the last year.

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I have been treated with dupilumab before.

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I haven't taken any immune system altering drugs or undergone specific skin treatments in the last 4 weeks.

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I am currently infected with hepatitis B.

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I have been treated with tralokinumab before.

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I have HIV or tested positive for HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from Baseline in Children's Dermatology Life Quality Index (cDLQI)

Change from Baseline in DLQI

Change from Baseline in Dermatology Life Quality Index (DLQI)

+2 more

Side effects data

From 2022 Phase 3 trial • 424 Patients • NCT04146363

13%

Covid-19

10%

Nasopharyngitis

Dermatitis atopic

Conjunctivitis allergic

Benign prostatic hyperplasia

Aspartate aminotransferase increased

Contusion

Sinusitis

Vulvovaginal candidiasis

Oral herpes

Headache

Alanine aminotransferase increased

Eyelid oedema

Back pain

Alopecia

Micturition disorder

Eyelid irritation

Ligament sprain

Osteoarthritis

Tooth infection

Somatic symptom disorder

Vaccination complication

Cholecystitis

Impetigo

Hepatic steatosis

Food allergy

Postoperative wound infection

Overdose

Myalgia

Cough

Solar lentigo

Sunburn

Otitis media

Upper respiratory tract infection

Blood lactate dehydrogenase increased

Pruritus

Urticaria

Conjunctivitis

Herpes dermatitis

Urinary tract infection

Weight increased

Sciatica

Erythema

Papule

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q4W

Escape Arm Week 16 - Maintenance OL- Lebrikizumab Non-Responder/Lebrikizumab Q2W

Escape Arm Week 16 - Maintenance Open Label (OL) -Placebo Non-Responder/Lebrikizumab Q2W

Maintenance Blinded - Placebo Responder/Lebrikizumab Q4W

Maintenance Blinded - Placebo Responder/ Lebrikizumab Q2W

Maintenance Blinded - Placebo Responder/ Placebo

Induction - Placebo

Maintenance Blinded - Lebrikizumab Responder/ Placebo

Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q2W

Escape Arm Week 24 to 48 - Maintenance Lebrikizumab

Induction - Lebrikizumab 250mg Q2W

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LebrikizumabExperimental Treatment1 Intervention

Participants will receive Lebrikizumab subcutaneously (SC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lebrikizumab

2014

Completed Phase 3

~6770

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atopic Dermatitis (AD) treatments often target the immune system to reduce inflammation and alleviate symptoms. IL-13 inhibitors like Lebrikizumab work by blocking the IL-13 cytokine, which plays a crucial role in the inflammatory response associated with AD. This helps to reduce skin inflammation and improve barrier function. Other common treatments include topical corticosteroids, which reduce inflammation and immune response, and calcineurin inhibitors, which suppress T-cell activation. Biologics like dupilumab target IL-4 and IL-13 pathways, further reducing inflammation. Understanding these mechanisms is vital for AD patients as it helps tailor treatments to effectively manage their symptoms and improve their quality of life.

Recent developments in atopic dermatitis.