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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04922021
Other study ID # LP0145-1376
Secondary ID 2020-005541-16
Status Completed
Phase Phase 2
First received
Last updated
Start date July 14, 2021
Est. completion date September 26, 2022

Study information

Verified date July 2023
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 26, 2022
Est. primary completion date June 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
LEO 138559
LEO 138559 is an antibody given by injection just under the skin.
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.

Locations

Country Name City State
Canada LEO Pharma Investigational Site Markham Ontario
Canada LEO Pharma Investigational Site Mississauga Ontario
Canada LEO Pharma Investigational Site Peterborough Ontario
Germany LEO Pharma Investigational Site Berlin
Germany LEO Pharma Investigational Site Dresden
Germany LEO Pharma Investigational Site Leipzig
Germany LEO Pharma Investigational Site Lübeck
Poland LEO Pharma Investigational Site Krakow
Poland LEO Pharma Investigational Site Kraków
Poland LEO Pharma nvestigational Site Rzeszów
Poland LEO Pharma Investigational Site Warszawa
Poland LEO Pharma Investigational Site Wroclaw
United States LEO Pharma Investigational Site Birmingham Alabama
United States LEO Pharma Investigational Site Doral Florida
United States LEO Pharma Investigational Site Fountain Valley California
United States LEO Pharma Investigational Site Hialeah Florida
United States LEO Pharma Investigational Site Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject Week 0 to Week 16
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