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

NCT05470114 | Completed Phase 2 Results

• 2 other identifiers: LP0145-22742021-006211-28
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies 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 Outcomes (1)

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

  Between baseline and week 16

Study Arms (2)

LEO 138559

EXPERIMENTAL

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

Drug: LEO 138559

Dupixent®

ACTIVE COMPARATOR

Participants received injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).

Drug: Dupixent®

Interventions

LEO 138559 DRUG

LEO 138559 is an antibody given by subcutaneous injection.

LEO 138559

Dupixent® DRUG

Dupixent® is an antibody given by subcutaneous injection.

Dupixent®

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

LEO Investigational Site

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Disclosure
• Organization: Leo Pharma

disclosure@leo-pharma.com

+4544945888

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: July 22, 2022
• Study Start: May 19, 2022
• Primary Completion: June 7, 2023
• Study Completion: October 9, 2023
• Last Updated: March 11, 2025
• Results First Posted: February 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)