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LEO 138559 for Eczema

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 16

Awards & highlights

Study Summary

This trial tests 4 doses of a medicine (LEO 138559) for treating moderate to severe atopic dermatitis in adults. Participants are randomly assigned to doses of the medicine or a placebo and monitored for side effects and effectiveness throughout the trial.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Number of treatment-emergent adverse events (TEAEs) recorded for each subject

Side effects data

From 2022 Phase 2 trial • 58 Patients • NCT04922021

21%

COVID-19

14%

Dermatitis atopic

10%

Nasopharyngitis

Conjunctivitis

Urticaria

Arthralgia

Headache

Pyrexia

Rhinitis allergic

Oral pain

Fatigue

Influenza like illness

Injection site reaction

Coronavirus infection

Cystitis

Eczema herpeticum

Erysipelas

Impetigo

Upper respiratory tract infection

Head injury

Vaccination complication

Rhinitis

Dermatitis acneiform

Gastrooesophageal reflux disease

Dermatitis

Haemoptysis

Oropharyngeal pain

Spinal pain

Burning sensation

Syncope

Renal pain

100%

80%

60%

40%

20%

Study treatment Arm

LEO 138559

Placebo

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor

269 Previous Clinical Trials

188,413 Total Patients Enrolled

Medical ExpertStudy DirectorLEO Pharma

53 Previous Clinical Trials

9,851 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants below the age of 75 being enlisted in this experiment?

"This trial has set the age criteria from 18 to 75; however, there are separate studies for participants aged below 18 and above 65. Specifically, 94 trials exist for children under the age of 10 while 172 can be found for those over 65 years old."

Answered by AI

Has the FDA sanctioned Dose regimen 2?

"Our in-house evaluation has given Dose regimen 2 a rating of 2, as Phase Two trials have produced some evidence supporting its safety but none for efficacy."

Answered by AI

To what extent has this clinical trial been implemented in hospitals across the state?

"At the moment, 9 places are signing up volunteers for this trial. These locations range from San Francisco to Hialeah and Ann Arbor, with several other spots in between. To reduce travel complications you should select a nearby location when enrolling."

Answered by AI

Are there any available places in this experiment for participants?

"Presently, this medical trial is not admitting patients - the original post date was September 20th of 2023 and it has been modified as recently as September 29th. Despite this particular study's closure, there are still 239 other clinical studies that actively seek participants."

Answered by AI

Does this experiment have any openings for new volunteers?

"This trial is searching for 250 volunteers with a one-year history of atopic dermatitis, aged 18 to 75. To be eligible to participate, they must have obtained signed and dated informed consent prior to any protocol related procedures; have an Eczema Area and Severity Index (EASI) score of ≥12 at screening/baseline; validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of ≥3 at screening/baseline; Body Surface Area (BSA) involvement of ≥10% at screening/baseline; weekly average Atopic Dermatitis Symptom Diary"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis

2023. "A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05923099.

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