What side effects are associated with this type of intervention?

Common treatments for Atopic Dermatitis (AD) include topical corticosteroids, topical calcineurin inhibitors, and biologics such as Dupilumab (an IL-4 and IL-13 inhibitor). Topical corticosteroids can cause skin thinning, stretch marks, and increased risk of skin infections. Topical calcineurin inhibitors may lead to burning sensations and increased risk of skin infections. Dupilumab, similar to Lebrikizumab, can cause conjunctivitis, injection site reactions, and potential allergic reactions. Lebrikizumab, being an IL-13 inhibitor, is expected to have a similar side effect profile to Dupilumab, focusing on injection site reactions and possible eye-related issues.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, particularly focusing on 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. It has shown significant efficacy in reducing symptoms and improving quality of life. Other treatments include topical calcineurin inhibitors like tacrolimus and pimecrolimus, which modulate the immune response. More recently, JAK inhibitors such as abrocitinib and upadacitinib have been approved, offering new options for patients with moderate-to-severe atopic dermatitis. These treatments, like Lebrikizumab, aim to modulate the immune system to reduce inflammation and other symptoms of atopic dermatitis.

What other types of research exist?

Promising novel alternatives to Lebrikizumab for Atopic Dermatitis patients in 2024 include: 1) Tralokinumab, an IL-13 inhibitor, which has shown efficacy in AD. 2) Upadacitinib, a JAK1 inhibitor, which has demonstrated significant improvement in AD symptoms. 3) Abrocitinib, another JAK1 inhibitor, which has also shown promising results in clinical trials for AD.

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Monoclonal Antibodies

Lebrikizumab for Eczema (ADapt 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

Participants must have prior treatment with dupilumab meeting specific conditions

Participants must have ≥10% body surface area (BSA) of AD involvement at baseline

Must not have

Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening

Uncontrolled asthma that might require bursts of oral or systemic corticosteroids or required systemic corticosteroid treatment or hospitalization for >24 hours due to 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 will test the safety and effectiveness of lebrikizumab in people with severe eczema who have already tried another treatment called Dupilumab. Lebrikizumab aims to reduce skin inflammation by blocking a protein that causes it.

Who is the study for?

Adults and adolescents with moderate-to-severe atopic dermatitis (AD) who previously used Dupilumab but stopped due to intolerance, adverse events, cost issues, or lack of efficacy. They must have had AD for over a year, an IGA score of ≥3, EASI score ≥16, and at least 10% body surface area affected. Adolescents must weigh ≥40 kg. Exclusions include HIV infection, uncontrolled asthma requiring steroids recently, liver disease like cirrhosis/hepatitis, recent use of certain AD treatments including Dupilumab.

What is being tested?

The trial is testing the safety and effectiveness of Lebrikizumab in those who've had previous treatment with Dupilumab without success or could not tolerate it. The goal is to see if Lebrikizumab can improve symptoms in patients with moderate-to-severe AD.

What are the potential side effects?

While specific side effects for Lebrikizumab are not listed here, common side effects for medications treating atopic dermatitis may include injection site reactions, eye problems like redness or itching (conjunctivitis), headaches and cold sores.

Eligibility Criteria

Inclusion Criteria

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

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I have been treated with dupilumab under certain conditions.

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

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I weigh at least 40 kg.

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Topical treatments have not worked for me or are not suitable due to my health.

Exclusion Criteria

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

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I frequently need oral steroids for a chronic condition.

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My asthma has been severe, needing steroids or hospital stays in the last year.

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I haven't used any skin creams for my condition in the last 2 weeks.

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I have liver cirrhosis or chronic hepatitis.

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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)

+1 more

Side effects data

From 2022 Phase 3 trial • 424 Patients • NCT04146363

Conjunctivitis allergic

Conjunctivitis

Asthma

Dermatitis atopic

Nasopharyngitis

Headache

Depression

Eosinophilia

Rhinitis allergic

Dysmenorrhoea

Ocular hyperaemia

Acne

Dry eye

Covid-19

Vaginal haemorrhage

Herpes dermatitis

Tooth abscess

Penile squamous cell carcinoma

Tonsillitis

Strongyloides test positive

Ingrowing nail

Contusion

Eye pain

Arthritis

Procedural pain

Eosinophil count increased

Haemoglobin urine present

Thermal burn

Epistaxis

Blood phosphorus decreased

Angle closure glaucoma

Vomiting

Urine bilirubin increased

Neutropenia

Pertussis

Respiratory tract infection viral

Pelvic fracture

Sleep disorder

Dyspnoea

Injection site reaction

Endophthalmitis

Labyrinthitis

Tinea cruris

Cellulitis

Conjunctival disorder

Radius fracture

Protein urine present

Deafness unilateral

Neck pain

Delirium

Glaucomatocyclitic crises

Constipation

Blood uric acid increased

Thrombocytopenia

Pyrexia

Herpes simplex

Periarthritis

Galactorrhoea

Lacrimation increased

Lymphopenia

Vertigo

Oral herpes

Upper limb fracture

Nitrite urine present

Urine leukocyte esterase positive

Hypercholesterolaemia

Obesity

Histiocytic necrotising lymphadenitis

Migraine

Blepharitis

Upper respiratory tract infection

Urinary tract infection

Vaccination complication

Essential tremor

Reflux laryngitis

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Blinded - Placebo Responder/Lebrikizumab Q4W

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

Maintenance Blinded - Placebo Responder/ Lebrikizumab Q2W

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

Maintenance Blinded - Placebo Responder/ Placebo

Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q4W

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 by subcutaneous (SC) injection.

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 pathways of AD, thereby reducing skin inflammation and improving barrier function. Topical corticosteroids suppress a broad range of inflammatory responses, providing quick relief from itching and redness. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, inhibit T-cell activation, reducing inflammation without the side effects associated with steroids. JAK inhibitors block the Janus kinase pathways involved in the immune response, offering another method to control inflammation. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific inflammatory pathways involved in their AD.

Recent developments in atopic dermatitis.