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NCT05277571 · ClinicalTrials.gov registry record · Phase 1
A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)
A Phase 1 study, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
NCT05277571: Completed Phase 1 study, sponsored by UCB Biopharma SRL.
NCT05277571 is a Phase 1 study that has completed, run by UCB Biopharma SRL. The registered enrollment target is 109 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05277571, a Phase 1 study, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
Study Summary
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Interventions
- DRUG Placebo
- BIOLOGICAL UCB1381
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2025-09-19 |
| Phase | Phase 1 |
What the finished NCT05277571 record still lists
NCT05277571 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05277571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05277571 about?
NCT05277571 is a clinical study titled "A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)". The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intrav...
What is the current status of trial NCT05277571?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2022-03-07. Estimated completion is 2025-09-19.
What interventions are being tested in trial NCT05277571?
The interventions under investigation include: Placebo (DRUG), UCB1381 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05277571?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05277571's enrollment target sits among peer trials
109 522nd of 2000 higher than 1,478 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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