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LEO 138559 for Atopic Dermatitis

Phase 1
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 85

Summary

This trial will test a new drug called LEO 138559 in healthy Japanese people. It will check how the drug moves through their bodies, if it causes any immune reactions, and if it is safe to use.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 85 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC0-inf: area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time
AUC0-last: the area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration
CL/F: apparent total body clearance
+4 more

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

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LEO 138559 Dose 3Experimental Treatment1 Intervention
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
Group II: LEO 138559 Dose 2Experimental Treatment1 Intervention
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
Group III: LEO 138559 Dose 1Experimental Treatment1 Intervention
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
Group IV: PlaceboPlacebo Group1 Intervention
LEO 138559 placebo will be administered subcutaneously up to 3 injections per dosing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LEO 138559
2018
Completed Phase 2
~150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

LEO PharmaLead Sponsor
271 Previous Clinical Trials
188,848 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
10,287 Total Patients Enrolled
~6 spots leftby Nov 2025
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