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NCT06577116 · ClinicalTrials.gov registry record · Phase 1
Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
A Phase 1 study of Chronic Spontaneous Urticaria, sponsored by Allakos.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 14
- Study locations
NCT06577116 is a Phase 1 study of Chronic Spontaneous Urticaria that has completed, run by Allakos. The registered enrollment target is 29 participants, below the 1,426-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (98% lower). The trial reports 14 study locations across 11 states.
The verdict
NCT06577116, a Phase 1 study of Chronic Spontaneous Urticaria, has completed, sponsored by Allakos.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 14
- Study locations
Study Summary
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.
Conditions Studied
Interventions
- DRUG AK006 IV
Study Locations (14)
California
- Site 601-014 - Bakersfield
- Site 601-015 - Upland
Ontario
- Site 601-107 - Niagara Falls
- Site 601-108 - Toronto
Quebec
- Site 601-102 - Québec
- Site 601-105 - Québec
Alabama
- Site 601-004 - Birmingham
Kansas
- Site 601-006 - Overland Park
Kentucky
- Site 601-019 - Lexington
Missouri
- Site 601-011 - St Louis
Ohio
- Site 601-002 - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2024-08-28 |
| Est. Completion | 2025-05-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06577116
The ClinicalTrials.gov registry entry for NCT06577116 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,426-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (98% lower). The listed sponsor is Allakos, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 1 intervention - of which AK006 IV is the first listed.
NCT06577116 reports 14 study locations spanning 11 distinct geographic areas - top geographies include California, Ontario, Quebec.
Frequently Asked Questions
What is clinical trial NCT06577116 about?
NCT06577116 is a clinical study titled "Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001". An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infu...
What is the current status of trial NCT06577116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2024-08-28. Estimated completion is 2025-05-21.
What conditions does trial NCT06577116 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT06577116?
The interventions under investigation include: AK006 IV (DRUG).
Who is sponsoring clinical trial NCT06577116?
This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06577116 being conducted?
This trial has 14 study locations across Alabama, California, Kansas, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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