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NCT05923099 · ClinicalTrials.gov registry record · Phase 2
A Trial to Evaluate the Efficacy and Safety of Different Doses 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
- 262
- Enrollment target
NCT05923099: Completed Phase 2 study, sponsored by LEO Pharma.
NCT05923099 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 262 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05923099, a Phase 2 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 262 participants
- Enrollment target
Study Summary
The purpose of this trial is to test different doses of the trial medicine (LEO 138559) and see how well they work and how safe they are at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses. The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks. The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin. At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life. LEO 138559 is also called "Temtokibart".
Primary Outcome
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe, and/or more extensive condition.
Interventions
- DRUG Placebo
- DRUG LEO 138559
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2023-09-20 |
| Est. Completion | 2025-04-09 |
| Phase | Phase 2 |
What the finished NCT05923099 record still lists
NCT05923099 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05923099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05923099 about?
NCT05923099 is a clinical study titled "A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis". The purpose of this trial is to test different doses of the trial medicine (LEO 138559) and see how well they work and how safe they are at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't...
What is the current status of trial NCT05923099?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 262 participants. The study started on 2023-09-20. Estimated completion is 2025-04-09.
What interventions are being tested in trial NCT05923099?
The interventions under investigation include: Placebo (DRUG), LEO 138559 (DRUG).
Who is sponsoring clinical trial NCT05923099?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05923099's enrollment target sits among peer trials
262 210th of 2000 higher than 1,791 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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