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

NCT06577116 | Completed Phase 1 FDA Drug

• 1 other identifier: AK006-001X
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 14

Brief 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

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation

  Through study completion, approximately 30 weeks

• Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs

  Through study completion, approximately 30 weeks

Secondary Outcomes (2)

• AK006 serum concentrations

  Through study completion, approximately 30 weeks

• AK006 Anti-drug Antibodies (ADAs)

  Through study completion, approximately 30 weeks

Study Arms (1)

720mg of AK006 IV

EXPERIMENTAL

Subjects in this arm will receive 4 doses of 720mg of AK006 via intravenous infusion every 4 weeks.

Drug: AK006 IV

Interventions

AK006 IV DRUG

Formulation for intravenous infusion

720mg of AK006 IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in Part C of Study AK006-001 (NCT06072157) and completed the randomized, double-blind, placebo-controlled treatment period and the Day 99 Visit.
• Acceptable demonstration of tolerance to study drug during the AK006-001 study as determined by the investigator.
• Acceptable demonstration of protocol compliance during the AK006-001 study as determined by the investigator.
• Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use a highly effective method of contraception with \<1% failure rate or abstain from sexual activity from Screening until the end of the study, or for 16 weeks following the last dose of AK006, whichever is longer.

You may not qualify if:

• Pregnant, breastfeeding, or planning to become pregnant while participating in the study.
• Planned use of an approved or investigational therapy to treat CSU other than a single 2nd- or later-generation H1-AH between 1× and 4× the licensed dose and frequency, during the study.

Sponsors & Collaborators

• Allakos Inc.: lead

Study Sites (14)

Site 601-004

Birmingham, Alabama, 35209, United States

Location

Site 601-014

Bakersfield, California, 93301, United States

Location

Site 601-015

Upland, California, 91786, United States

Location

Site 601-006

Overland Park, Kansas, 66211, United States

Location

Site 601-019

Lexington, Kentucky, 40509, United States

Location

Site 601-011

St Louis, Missouri, 63141, United States

Location

Site 601-002

Cincinnati, Ohio, 45236, United States

Location

Site 601-010

El Paso, Texas, 79912, United States

Location

Site 601-013

Greenfield, Wisconsin, 53228, United States

Location

Site 601-106

Calgary, Alberta, T2M 1A6, Canada

Location

Site 601-107

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Site 601-108

Toronto, Ontario, M5G 1E2, Canada

Location

Site 601-102

Québec, Quebec, G1V 4W2, Canada

Location

Site 601-105

Québec, Quebec, G1W 4R4, Canada

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: August 28, 2024
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CA (5); US (9)