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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

Study Summary

This trial is testing a new drug (LEO 138559) to see if it's effective in treating atopic dermatitis, and to compare its side effects to a placebo. The study will last up to 36 weeks, with participants receiving injections for 16 weeks, followed by 16 weeks without treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in EASI Score From Baseline to Week 16
Secondary outcome measures
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject

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

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
268 Previous Clinical Trials
188,393 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
53 Previous Clinical Trials
10,043 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
An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.
2021. "An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04922021.
~15 spots leftby Apr 2025
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