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Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
NCT06577116 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allakos, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06577116 reports 14 study locations spanning 11 distinct geographic areas — top geographies include California, Ontario, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06577116?
The interventions under investigation include: AK006 IV (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06577116?
This trial is sponsored by Allakos, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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