Back to resultsA Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD
Primary Purpose
Atopic Dermatitis
Status
Active
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
LEO 138559
Dupixent®
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
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.
Sites / Locations
- LEO Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LEO 138559
Dupixent®
Arm Description
Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
Participants will receive injections of Dupixent® from Week 0 (baseline) to Week 16 (end of treatment).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of treatment-emergent adverse events from baseline to week 16 per subject
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05470114
Brief Title
A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
June 27, 2023 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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
13 (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
Dupixent®
Arm Type
Active Comparator
Arm Description
Participants will receive injections of Dupixent® 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 subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Dupixent®
Intervention Description
Dupixent® is an antibody given by subcutaneous injection.
Primary Outcome Measure Information:
Title
Change in gene expression typically associated with atopic dermatitis in lesional skin biopsies from baseline to week 4
Description
Lesional skin biopsies will be evaluated by single cell RNA sequencing to evaluate global gene expression
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Number of treatment-emergent adverse events from baseline to week 16 per subject
Time Frame
Between baseline and 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:
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.
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 Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
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 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
A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD
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