NCT04922021

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

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	LEO 138559	LEO 138559 is an antibody given by injection just under the skin.
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.

Timeline

• Start date: 2021-07-14
• Primary completion: 2022-06-02
• Completion: 2022-09-26
• First posted: 2021-06-10
• Last updated: 2025-03-13
• Results posted: 2023-07-24

Locations

17 sites across 4 countries: United States, Canada, Germany, Poland

Regulatory

• FDA-regulated drug study