What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly those involving IL-13 inhibition like Lebrikizumab, include biologic agents such as dupilumab. Known side effects of these treatments can include injection site reactions, conjunctivitis, blepharitis, and cold sores. Other systemic treatments like corticosteroids and immunosuppressants (e.g., cyclosporine) may cause side effects such as increased risk of infections, hypertension, and kidney dysfunction. Phototherapy, another treatment option, can lead to skin burning and increased risk of skin cancer with long-term use.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for Atopic Dermatitis, focusing on targeting 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 works by inhibiting the signaling of these interleukins, which are key drivers of the inflammatory response in Atopic Dermatitis. Other treatments include topical corticosteroids and calcineurin inhibitors like tacrolimus and pimecrolimus, which have been used for managing symptoms. The ongoing study of Lebrikizumab, an IL-13 inhibitor, represents a continued effort to target specific cytokines involved in the pathophysiology of Atopic Dermatitis.

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), Upadacitinib (JAK1 inhibition), and Abrocitinib (JAK1 inhibition). These treatments have demonstrated efficacy and safety in recent clinical trials and are considered potential options for AD management in 2024.

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Monoclonal Antibodies

Lebrikizumab for Eczema (ADjoin 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 for the Open-Label Addendum must be male or female adults and adolescents, have Chronic AD, Eczema Area and Severity Index (EASI) score ≥16 at baseline, Investigator Global Assessment (IGA) score ≥3 at baseline, ≥10% body surface area (BSA) of AD involvement at baseline, and history of inadequate response to treatment with topical medications or determination that topical treatments are medically inadvisable

Must not have

Participants for the Open-Label Addendum will be excluded if they have evidence of active acute or chronic hepatitis, history of HIV infection, history of malignancy within 5 years before screening, or other specified medical conditions

Participants for the Open-Label Addendum will be excluded if they have received a dose of lebrikizumab in any prior lebrikizumab clinical study, have a history of anaphylaxis, or have received certain topical medications within specific timeframes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the safety and effectiveness of lebrikizumab, a medication for eczema. It targets people with moderate-to-severe atopic dermatitis, including those from previous studies and new participants. Lebrikizumab works by blocking a protein that causes inflammation and itching.

Who is the study for?

Adults and adolescents (12+ years, ≥40 kg) with chronic moderate-to-severe atopic dermatitis for over a year, who haven't responded well to topical treatments. Participants must not be pregnant or breastfeeding, agree to contraception if applicable, and have no recent live vaccines or use of certain drugs. Excludes those with serious reactions to lebrikizumab in past trials.

What is being tested?

The trial is testing the long-term safety and effectiveness of Lebrikizumab in treating moderate-to-severe atopic dermatitis over a period of 110 weeks. It aims to see how well it works over time and what side effects may occur with extended use.

What are the potential side effects?

Potential side effects are not detailed here but could include typical drug-related reactions such as injection site discomfort, allergic responses, immune system changes leading to increased infection risk or inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have chronic eczema, it's severe, and topical treatments haven't worked for me.

Exclusion Criteria

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

Select...

I don't have hepatitis, HIV, cancer in the last 5 years, or certain medical conditions.

Select...

I have never taken lebrikizumab or had a severe allergic reaction.

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I have not used certain immune drugs, had phototherapy, or received live vaccines recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Lebrikizumab Q8W (Open-Label Extension Addendum)Experimental Treatment1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q8W by SC injection.

Group II: Lebrikizumab Q4W (Open-Label Extension Addendum)Experimental Treatment1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q4W by SC injection.

Group III: Lebrikizumab Q4WExperimental Treatment1 Intervention

Participants assigned to lebrikizumab Q4W (once every 4 weeks) arm will receive investigational product Q4W by SC injection. Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.

Group IV: Lebrikizumab Q2W (Open-Label) from Parent StudyExperimental Treatment1 Intervention

Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.

Group V: Lebrikizumab Q2W (Open-Label Extension Addendum)Experimental Treatment1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q2W by SC injection.

Group VI: Lebrikizumab Q2W (Open-Label Addendum)Experimental Treatment1 Intervention

Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.

Group VII: Lebrikizumab Q2W (Blinded) from Parent StudyExperimental Treatment1 Intervention

Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lebrikizumab

2014

Completed Phase 3

~6770

0 / 4Eligibility 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 and skin barrier dysfunction in AD. This helps to reduce inflammation and improve skin integrity. 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 and improving skin symptoms. Understanding these mechanisms is vital for AD patients as it helps in selecting the most effective treatment tailored to their specific immune response profile.

Recent developments in atopic dermatitis.