What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, which can cause skin thinning, stretch marks, and systemic effects if used long-term. Topical calcineurin inhibitors, such as tacrolimus, may lead to burning sensations, itching, and increased risk of skin infections. Phosphodiesterase type-4 inhibitors, like OPA-15406, generally have mild to moderate side effects, including application site reactions. Biologics, such as dupilumab, can cause injection site reactions, conjunctivitis, and potential allergic reactions. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

Several treatments have been FDA-approved for moderate-to-severe atopic dermatitis, including biologics and systemic therapies. Dupilumab, a monoclonal antibody targeting IL-4 and IL-13, is a prominent biologic treatment. Other systemic therapies include cyclosporine, methotrexate, and azathioprine. Recently, JAK inhibitors like abrocitinib and upadacitinib have also been approved, offering additional options for patients with this condition.

What other types of research exist?

Promising novel alternatives to LEO 138559 for atopic dermatitis include: 1) Crisaborole ointment, a non-steroidal phosphodiesterase 4 inhibitor, which has shown safety and efficacy in clinical trials. 2) Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha, which has been effective in reducing symptoms of atopic dermatitis. 3) Topical E6005, another phosphodiesterase 4 inhibitor, which has demonstrated safety and efficacy in clinical trials. These alternatives offer different mechanisms of action and have shown promising results in recent studies.

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LEO 138559 for Eczema

Phase 2

Waitlist Available

Research Sponsored by LEO Pharma

Eligibility Criteria Checklist

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

Must have

Aged 18-75 years old at screening

Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at screening and baseline

Must not have

Treatment with any marketed or investigational biologic agents within 3 months or 5 half-lives, whichever is longer, prior to baseline

Subjects who are legally institutionalized

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 16

Summary

This trial is testing a new medicine called LEO 138559 to treat adults with moderate to severe atopic dermatitis. The goal is to find out which amount works best to reduce symptoms like itching and redness.

Who is the study for?

Adults aged 18-75 with moderate-to-severe atopic dermatitis (eczema) who haven't responded well to typical skin treatments can join. They must have a certain severity of eczema, as measured by specific scales, and be willing to use effective birth control if applicable. People can't participate if they're allergic to trial ingredients, pregnant or breastfeeding, have had the trial drug before, suffer from tuberculosis or cancer (with some exceptions), are at risk of suicide, recently had major surgery or infections.

What is being tested?

The study is testing how safe and effective different doses of LEO 138559 are compared to a placebo in treating adult eczema. Participants will receive one of four doses or a dummy injection for up to 16 weeks and will be monitored for another 16 weeks after treatment ends. The medicine is given via injections under the skin at regular clinic visits where their condition and any side effects are checked.

What are the potential side effects?

While not specified here, common side effects in trials like this may include reactions at the injection site such as redness or pain, potential allergic reactions to components of LEO 138559, headaches, cold symptoms like sore throat and stuffy nose; however exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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My eczema is moderate to severe.

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My worst weekly itch score is 4 or more.

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I have had Alzheimer's disease for at least 1 year.

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My skin condition affects at least 10% of my body.

Exclusion Criteria

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

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I haven't taken any biologic drugs for 3 months or 5 half-lives, whichever is longer.

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I am currently living in a legal institution.

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I haven't taken any medication that reduces my immune cells in the last 6 months or until my immune cell count returned to normal, whichever took longer.

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I haven't taken any experimental drugs recently.

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I have tested positive for hepatitis B or C.

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I have not had a serious infection in the last 4 weeks.

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I am not pregnant or breastfeeding.

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I have been treated with LEO 138559 before.

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I haven't had major surgery in the last 8 weeks and don't plan any during the trial.

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I have a history of or currently have an immunodeficiency syndrome.

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I have a skin condition that could affect the assessment of my treatment.

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I have been treated with fezakinumab before.

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I have HIV or tested positive for HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 16 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent change in Eczema Area and Severity Index (EASI) score

Side effects data

From 2022 Phase 2 trial • 58 Patients • NCT04922021

21%

COVID-19

14%

Dermatitis atopic

10%

Nasopharyngitis

Conjunctivitis

Headache

Arthralgia

Urticaria

Gastrooesophageal reflux disease

Oral pain

Fatigue

Pyrexia

Coronavirus infection

Cystitis

Influenza like illness

Injection site reaction

Eczema herpeticum

Erysipelas

Syncope

Impetigo

Rhinitis

Upper respiratory tract infection

Oropharyngeal pain

Burning sensation

Dermatitis

Head injury

Haemoptysis

Rhinitis allergic

Dermatitis acneiform

Vaccination complication

Spinal pain

Renal pain

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

LEO 138559

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose regimen 4Experimental Treatment1 Intervention

Dose C every week from Week 0 to Week 3, then dose D every 2 weeks from Week 4 to Week 16

Group II: Dose regimen 3Experimental Treatment1 Intervention

Dose A every week from Week 0 to Week 3, then dose C every 2 weeks from Week 4 to Week 16

Group III: Dose regimen 2Experimental Treatment1 Intervention

Dose B every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16

Group IV: Dose regimen 1Experimental Treatment1 Intervention

Dose A every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16

Group V: Placebo regimenPlacebo Group1 Intervention

Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LEO 138559

2018

Completed Phase 2

~150

0 / 18Eligibility 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

Common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors, and biologics like dupilumab. Topical corticosteroids reduce inflammation and suppress immune responses in the skin, 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. Biologics like dupilumab target specific pathways in the immune system, such as the interleukin-4 and interleukin-13 pathways, to reduce chronic inflammation and improve skin barrier function. These treatments are crucial for AD patients as they help manage symptoms, prevent flare-ups, and improve quality of life by addressing the underlying immune dysregulation.