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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LEO 138559
LEO 138559 placebo
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma nvestigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LEO 138559

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2021
Last Updated
July 3, 2023
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04922021
Brief Title
An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
September 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 138559
Arm Type
Experimental
Arm Description
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment).
Intervention Type
Drug
Intervention Name(s)
LEO 138559
Intervention Description
LEO 138559 is an antibody given by injection just under the skin.
Intervention Type
Drug
Intervention Name(s)
LEO 138559 placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in EASI Score From Baseline to Week 16
Description
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.
Time Frame
Week 0 to Week 16
Secondary Outcome Measure Information:
Title
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Time Frame
Week 0 to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Pharma Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Kraków
ZIP/Postal Code
31-011
Country
Poland
Facility Name
LEO Pharma nvestigational Site
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Warszawa
ZIP/Postal Code
02-625
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://leopharmatrials.com/for-professionals

Learn more about this trial

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

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