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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
Awards & highlights

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 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
7%
Conjunctivitis
7%
Headache
7%
Arthralgia
7%
Urticaria
3%
Gastrooesophageal reflux disease
3%
Oral pain
3%
Fatigue
3%
Pyrexia
3%
Coronavirus infection
3%
Cystitis
3%
Influenza like illness
3%
Injection site reaction
3%
Eczema herpeticum
3%
Erysipelas
3%
Syncope
3%
Impetigo
3%
Rhinitis
3%
Upper respiratory tract infection
3%
Oropharyngeal pain
3%
Burning sensation
3%
Dermatitis
3%
Head injury
3%
Haemoptysis
3%
Rhinitis allergic
3%
Dermatitis acneiform
3%
Vaccination complication
3%
Spinal pain
3%
Renal pain
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor
270 Previous Clinical Trials
188,401 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
10,049 Total Patients Enrolled
~37 spots leftby Dec 2024