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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04922021
Recruitment Status : Active, not recruiting
First Posted : June 10, 2021
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: LEO 138559 Drug: LEO 138559 placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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).
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : July 8, 2022
Estimated Study Completion Date : October 21, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: LEO 138558
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 the medical ingredient LEO 138559.




Primary Outcome Measures :
  1. Change in EASI score from baseline to Week 16 [ Time Frame: Week 0 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 :
  1. Number of treatment-emergent adverse events from baseline to Week 16 per subject [ Time Frame: Week 0 to Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04922021


Locations
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United States, Alabama
LEO Pharma Investigational Site
Birmingham, Alabama, United States, 35209
United States, California
LEO Pharma Investigational Site
Fountain Valley, California, United States, 92708
LEO Pharma Investigational Site
Los Angeles, California, United States, 90045
United States, Florida
LEO Pharma Investigational Site
Doral, Florida, United States, 33122
LEO Pharma Investigational Site
Hialeah, Florida, United States, 33012
Canada, Ontario
LEO Pharma Investigational Site
Markham, Ontario, Canada, L3P 1X3
LEO Pharma Investigational Site
Mississauga, Ontario, Canada, L5H 1G9
LEO Pharma Investigational Site
Peterborough, Ontario, Canada, K9J 5K2
Germany
LEO Pharma Investigational Site
Berlin, Germany, 10117
LEO Pharma Investigational Site
Dresden, Germany, 01307
LEO Pharma Investigational Site
Leipzig, Germany, 04103
LEO Pharma Investigational Site
Lübeck, Germany, 23538
Poland
LEO Pharma Investigational Site
Krakow, Poland, 30-033
LEO Pharma Investigational Site
Kraków, Poland, 31-011
LEO Pharma nvestigational Site
Rzeszów, Poland, 35-055
LEO Pharma Investigational Site
Warszawa, Poland, 02-625
LEO Pharma Investigational Site
Wrocław, Poland, 51-685
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT04922021    
Other Study ID Numbers: LP0145-1376
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available to request after results of the trial are available on leopharmatrials.com.
Access Criteria: Data sharing is subject to approved scientifically sound research proposal and signed data sharing agreement.
URL: http://leopharmatrials.com/for-professionals

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases