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NCT04922021 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by LEO Pharma.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target

NCT04922021: Completed Phase 2 study, sponsored by LEO Pharma.

NCT04922021 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04922021, a Phase 2 study, has completed, sponsored by LEO Pharma.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG LEO 138559
  • DRUG LEO 138559 placebo

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2021-07-14
Est. Completion 2022-09-26
Phase Phase 2
LEO Pharma

65 total trials

What the finished NCT04922021 record still lists

NCT04922021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 2 interventions - of which LEO 138559 is the first listed.

NCT04922021 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04922021 about?

NCT04922021 is a clinical study titled "An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.". 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 ingre...

What is the current status of trial NCT04922021?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2021-07-14. Estimated completion is 2022-09-26.

What interventions are being tested in trial NCT04922021?

The interventions under investigation include: LEO 138559 (DRUG), LEO 138559 placebo (DRUG).

Who is sponsoring clinical trial NCT04922021?

This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04922021's enrollment target sits among peer trials

58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04922021, the US trial registry maintained by the National Library of Medicine. NCT04922021 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.