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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-28

Study Completion Date

2025-05-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Spontaneous Urticaria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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720mg of AK006 IV

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

Group Type EXPERIMENTAL

AK006 IV

Intervention Type DRUG

Formulation for intravenous infusion

Interventions

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AK006 IV

Formulation for intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No