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NCT05528861 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
A Phase 2 study, sponsored by Allakos.
- Terminated
- Registry status
- Phase 2
- Development phase
- 127
- Enrollment target
NCT05528861: Clinical Trial Phase 2 study, sponsored by Allakos.
NCT05528861 is a Phase 2 study that was terminated before completion, run by Allakos. The registered enrollment target is 127 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05528861, a Phase 2 study, was terminated before completion, sponsored by Allakos.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 127 participants
- Enrollment target
Study Summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 6 doses of subcutaneous lirentelimab.
Primary Outcome
The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The daily HSS is recorded on a scale of 0 (none) to 3 (\>50 hives) and the daily ISS is recorded on a scale of 0 (none) to 3 (severe). Therefore, the possible range of the weekly UAS7 score is 0-42, with 42 being the most severe.
Interventions
- OTHER Placebo
- DRUG Lirentelimab (AK002)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2024-04-18 |
| Phase | Phase 2 |
Why NCT05528861 stopped before completion
NCT05528861 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05528861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05528861 about?
NCT05528861 is a clinical study titled "A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria". This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. Subjects who complete the randomized, double-blind, placebo-c...
What is the current status of trial NCT05528861?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2022-10-26. Estimated completion is 2024-04-18.
What interventions are being tested in trial NCT05528861?
The interventions under investigation include: Placebo (OTHER), Lirentelimab (AK002) (DRUG).
Who is sponsoring clinical trial NCT05528861?
This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05528861's enrollment target sits among peer trials
127 555th of 2000 higher than 1,445 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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