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NCT Number: NCT06577116

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 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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 601-106, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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 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.

Treatment and study plan

AK006 IV

Drug

Formulation for intravenous infusion

Primary outcomes

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

    Time frame: Through study completion, approximately 30 weeks

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

    Time frame: Through study completion, approximately 30 weeks

Secondary outcomes

  1. AK006 serum concentrations

    Time frame: Through study completion, approximately 30 weeks

  2. AK006 Anti-drug Antibodies (ADAs)

    Time frame: Through study completion, approximately 30 weeks

    Number of participants with positive or negative AK006-ADAs.

Sponsors and collaborators

Lead sponsor

Allakos Inc.

Industry

Registry information

Official study title

An Open-Label Extension Study Evaluating the Safety, Tolerability, PK, Immunogenicity, and Clinical Response of Multiple Doses of IV AK006 in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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