NCT04922021|CompletedPhase 2ResultsFDA Drug

An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multi-site, Proof of Concept Trial to Evaluate the Efficacy and Safety of LEO 138559 in Adult Subjects With Moderate to Severe Atopic Dermatitis (AD).

LEO Pharma ClinicalTrials.gov

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2 other identifiers

LP0145-13762020-005541-16

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredJun 2021

StartedJul 2021

CompletionSep 2022

Brief Summary

This is a clinical study in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient. The study will last up to 36 weeks for each participant. The study will include a treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without treatment with the main purpose of continuing safety evaluations. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms and quality of life.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jul 2021

Shorter than P25 for phase_2

Geographic Reach

4 countries

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

June 7, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed

1 month until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2022

Completed

10 months until next milestone

Results Posted

Study results publicly available

July 24, 2023

Completed

Last Updated

March 13, 2025

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

June 7, 2021

Results QC Date

June 2, 2023

Last Update Submit

February 21, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

Change in EASI Score From Baseline to Week 16
The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive and/or severe condition.
Week 0 to Week 16

Secondary Outcomes (1)

Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Week 0 to Week 16

Study Arms (2)

LEO 138559

EXPERIMENTAL

Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).

Drug: LEO 138559

Placebo

PLACEBO COMPARATOR

Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment).

Drug: LEO 138559 placebo

Interventions

LEO 138559DRUG

LEO 138559 is an antibody given by injection just under the skin.

LEO 138559

LEO 138559 placeboDRUG

LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.

Placebo

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

years old (both included) at screening.
Diagnosis of atopic dermatitis (AD) (as defined by the American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year prior to screening.
Subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable.
Eczema Area and Severity Index (EASI) score ≥12 at screening and ≥16 at baseline.
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at screening and baseline.
Body surface area (BSA) of AD involvement ≥10% at screening and baseline.
Worst Daily Pruritus Numeric Rating Scale (NRS, weekly average) of ≥3 points at baseline.

You may not qualify if:

Treatment with systemic immunosuppressive/immunomodulating medication, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to randomization, whichever is longer.
Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to randomization, whichever is longer.
Treatment with topical corticosteroid(s) (TCS), topical calcineurin inhibitor(s) (TCI), topical phosphodiesterase-4 (PDE-4) inhibitor, or other topical prescription treatments within 1 week prior to randomization.
Treatment with a live (attenuated) vaccine within 12 weeks prior to randomization.
Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to randomization that may compromise the safety of the subject.
Skin infection within 1 week prior to the baseline visit.
Presence of hepatitis B or C infection at screening.
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
Participant has a positive or indeterminate test for tuberculosis at screening.
Participant is pregnant or lactating.

Contact the study team to confirm eligibility.