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

Atopic Dermatitis Clinical Trial

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).

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
• 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
• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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