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).

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: LEO 138559; Drug: LEO 138559 placebo

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada, L3P 1X3
      • LEO Pharma Investigational Site
    • Mississauga, Ontario, Canada, L5H 1G9
      • LEO Pharma Investigational Site
    • Peterborough, Ontario, Canada, K9J 5K2
      • LEO Pharma Investigational Site
• Germany
  • Berlin, Germany, 10117
    • LEO Pharma Investigational Site
  • Dresden, Germany, 01307
    • LEO Pharma Investigational Site
  • Leipzig, Germany, 04103
    • LEO Pharma Investigational Site
  • Lübeck, Germany, 23538
    • LEO Pharma Investigational Site
• Poland
  • Krakow, Poland, 30-033
    • LEO Pharma Investigational Site
  • Kraków, Poland, 31-011
    • LEO Pharma Investigational Site
  • Rzeszów, Poland, 35-055
    • LEO Pharma nvestigational Site
  • Warszawa, Poland, 02-625
    • LEO Pharma Investigational Site
  • Wrocław, Poland, 51-685
    • LEO Pharma Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • LEO Pharma Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • LEO Pharma Investigational Site
    • Los Angeles, California, United States, 90045
      • LEO Pharma Investigational Site
  • Florida
    • Doral, Florida, United States, 33122
      • LEO Pharma Investigational Site
    • Hialeah, Florida, United States, 33012
      • LEO Pharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-64 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 138559; Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).	Drug: LEO 138559; LEO 138559 is an antibody given by injection just under the skin.
Placebo Comparator: Placebo; Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment).	Drug: LEO 138559 placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject	Week 0 to Week 16

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: LP0145-1376; 2020-005541-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data are available to request after results of the trial are available on leopharmatrials.com.
• 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; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No