A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD

February 21, 2025 updated by: LEO Pharma

A Randomized, Double-blinded, Active Comparator-controlled, 16-week, Single-site, Exploratory, Mechanistic Trial to Assess the Effect of LEO 138559 on the Molecular Signature and Safety in Adults With Moderate to Severe Atopic Dermatitis.

This clinical trial will investigate the effectiveness and safety of a new active ingredient (LEO 138559) in the treatment of moderate to severe atopic dermatitis (AD). It is given by subcutaneous injection. Some people in the trial will instead receive Dupixent® which is an approved treatment for moderate to severe AD. Dupixent® is also given by subcutaneous injection.

The main aim of this clinical trial is to investigate which changes in biomarkers in the skin are caused by LEO 138559 and Dupixent®.

The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16 weeks, and a safety follow-up period of 16 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • LEO Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of AD [as defined by the American Academy of Dermatology (AAD) 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.
  • EASI score ≥12 at screening and ≥16 at baseline.
  • vIGA-AD score ≥3 at screening and baseline.
  • Body surface area (BSA) of AD involvement ≥10% at screening and baseline.
  • Worst Daily Pruritus NRS (weekly average) of ≥3 points at baseline.

Exclusion Criteria:

  • Treatment with systemic immunosuppressive/immunomodulating medication (excluding systemic antihistamines if taken at stable dose already before baseline), e.g., JAK inhibitors, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to baseline, whichever is longer.
  • Treatment with systemic corticosteroids within 4 weeks prior to baseline (NOTE: Inhaled or intranasal steroids equivalent to doses including and up to 500 µg beclometasone (or equivalent) daily is allowed).
  • Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to baseline, whichever is longer.
  • Treatment with TCS, TCI, or topical PDE-4 inhibitor within 1 week prior to baseline (NOTE: Patient may be rescreened (one time) if failed for this criterion.
  • Intake of nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to baseline. Intake of paracetamol will be allowed.
  • Treatment with a live (attenuated) vaccine within 12 weeks prior to baseline.
  • Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to baseline that may compromise the safety of the subject.
  • Clinically significant abnormalities detected on vital signs or ECG (apart from 1st degree atrioventricular (AV) block that is allowed).
  • Serious heart conditions, chronic lung diseases.
  • Acute asthma, acute bronchospasm, moderate to severe asthma.
  • Skin infection within 1 week prior to the baseline visit.
  • Presence of hepatitis B or C infection at screening.
  • Active inflammatory bowel disease (IBD) or history of IBD, anaphylaxis, immune complex disease, pancreatic disease, zoster infections, viral skin infections (including eczema herpeticum) or known or suspected history of immunosuppressive disorder.
  • History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
  • Subject has a positive test for tuberculosis at screening.
  • Subject is pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEO 138559
Participants received injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
Drug: LEO 138559
LEO 138559 is an antibody given by subcutaneous injection.
Active Comparator: Dupixent®
Participants received injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).
Drug: Dupixent®
Dupixent® is an antibody given by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Time Frame: From baseline to week 4
Lesional skin biopsies will be evaluated by single cell RNA sequencing to evaluate global gene expression
From baseline to week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Time Frame: Between baseline and week 16
Between baseline and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Study Director: Medical Expert, LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Actual)

June 7, 2023

Study Completion (Actual)

October 9, 2023

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

July 21, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0145-2274
  • 2021-006211-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

IPD Sharing Access Criteria

Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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