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Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001

NCT06577116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-08-27

No results posted yet for this 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

Interventions

DRUG

AK006 IV

Formulation for intravenous infusion

Sponsors & Collaborators

  • Allakos Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-28
Primary Completion
2025-05-21
Completion
2025-05-21
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06577116 on ClinicalTrials.gov