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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 day 1(pre-dose), day 29, day 57, and day 85
Awards & highlights

Study Summary

This study is evaluating whether a drug called LEO 138559 can be safely given to healthy Japanese people.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1(pre-dose), day 29, day 57, and day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1(pre-dose), day 29, day 57, and day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Number of treatment emergent adverse events
Presence of binding anti-drug antibodies

Side effects data

From 2022 Phase 2 trial • 58 Patients • NCT04922021
21%
COVID-19
14%
Dermatitis atopic
10%
Nasopharyngitis
7%
Conjunctivitis
7%
Urticaria
7%
Arthralgia
7%
Headache
3%
Pyrexia
3%
Rhinitis allergic
3%
Oral pain
3%
Fatigue
3%
Influenza like illness
3%
Injection site reaction
3%
Coronavirus infection
3%
Cystitis
3%
Eczema herpeticum
3%
Erysipelas
3%
Impetigo
3%
Upper respiratory tract infection
3%
Head injury
3%
Vaccination complication
3%
Rhinitis
3%
Dermatitis acneiform
3%
Gastrooesophageal reflux disease
3%
Dermatitis
3%
Haemoptysis
3%
Oropharyngeal pain
3%
Spinal pain
3%
Burning sensation
3%
Syncope
3%
Renal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
LEO 138559
Placebo

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
268 Previous Clinical Trials
188,427 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
53 Previous Clinical Trials
10,077 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects
2021. "A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05099133.
~7 spots leftby Apr 2025
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