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Biologic

LEO 138559 for Atopic Dermatitis

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 16
Awards & highlights

Summary

This trial tests a new injectable medicine, LEO 138559, in adults with moderate to severe atopic dermatitis. The medicine is likely designed to reduce inflammation and help the skin heal. The study will last several months, including a treatment period and a follow-up period to monitor safety.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 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
Change in EASI Score From Baseline to Week 16

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LEO 138559Experimental Treatment1 Intervention
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LEO 138559
2018
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor
270 Previous Clinical Trials
188,591 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
10,239 Total Patients Enrolled
~14 spots leftby Sep 2025
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