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

NCT ID: NCT04922021

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2022-09-26

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LEO 138559

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

Group Type: EXPERIMENTAL

LEO 138559

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

LEO 138559 placebo

Intervention Type: DRUG

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.

Interventions

LEO 138559

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

Intervention Type: 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 for the medical ingredient LEO 138559.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

LEO Pharma Investigational Site

Birmingham, Alabama, United States

LEO Pharma Investigational Site

Fountain Valley, California, United States

LEO Pharma Investigational Site

Los Angeles, California, United States

LEO Pharma Investigational Site

Doral, Florida, United States

LEO Pharma Investigational Site

Hialeah, Florida, United States

LEO Pharma Investigational Site

Markham, Ontario, Canada

LEO Pharma Investigational Site

Mississauga, Ontario, Canada

LEO Pharma Investigational Site

Peterborough, Ontario, Canada

LEO Pharma Investigational Site

Berlin, , Germany

LEO Pharma Investigational Site

Dresden, , Germany

LEO Pharma Investigational Site

Leipzig, , Germany

LEO Pharma Investigational Site

Lübeck, , Germany

LEO Pharma Investigational Site

Krakow, , Poland

LEO Pharma Investigational Site

Krakow, , Poland

LEO Pharma nvestigational Site

Rzeszów, , Poland

LEO Pharma Investigational Site

Warsaw, , Poland

LEO Pharma Investigational Site

Wroclaw, , Poland

Countries

United States; Canada; Germany; Poland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-005541-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LP0145-1376

Identifier Type: -

Identifier Source: org_study_id