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

Phase 1

• Conditions: Chronic Spontaneous Urticaria
• Interventions: Drug: AK006 IV

• Registration Number: NCT06577116
• Lead Sponsor: Allakos Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Study Start: 2024-08-28
• Study First Posted: 2024-08-29
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-08
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Key

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
AK006 serum concentrations	Through study completion, approximately 30 weeks
AK006 Anti-drug Antibodies (ADAs)	Through study completion, approximately 30 weeks	Number of participants with positive or negative AK006-ADAs.

Trial Locations

Locations (13)

Site 601-013; 🇺🇸 Greenfield, Wisconsin, United States

Site 601-004; 🇺🇸 Birmingham, Alabama, United States

Site 601-014; 🇺🇸 Bakersfield, California, United States

Site 601-015; 🇺🇸 Upland, California, United States

Site 601-006; 🇺🇸 Overland Park, Kansas, United States

Site 601-019; 🇺🇸 Lexington, Kentucky, United States

Site 601-011; 🇺🇸 Saint Louis, Missouri, United States

Site 601-002; 🇺🇸 Cincinnati, Ohio, United States

Site 601-010; 🇺🇸 El Paso, Texas, United States

Site 601-107; 🇨🇦 Niagara Falls, Ontario, Canada

Site 601-108; 🇨🇦 Toronto, Ontario, Canada

Site 601-102; 🇨🇦 Québec, Quebec, Canada

Site 601-105; 🇨🇦 Québec, Quebec, Canada