Status:
COMPLETED
Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria
Lead Sponsor:
Allakos Inc.
Conditions:
Healthy Participants
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential, single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity o...
Eligibility Criteria
Inclusion
- Key
- To be included in the study, the participant must:
- Weigh between 60 and 120 kg (inclusive) and have a body mass index (BMI) between 20 and 32 kg/m2, inclusive
- Agree (female of childbearing potential or male with female partner of childbearing potential) to use a highly effective method (\<1% failure rate) of birth control, if sexually active from screening and for 16 weeks after the last dose of investigational product (IP).
- Additionally, to be included in Part A, B and D, the participant must:
- • Be in good general health with no significant medical history and has no clinically significant abnormalities on physical examination
- Additionally, to be included in Part C, the participant must:
- Have a diagnosis of chronic spontaneous urticaria (CSU) for at least 6 months prior to screening
- Has a diagnosis of moderate to severe CSU that is refractory to stable doses of a single 2nd or later generation H1-AH between 1× and 4× the licensed dose and frequency at the time of randomization as defined by the following:
- Presence of hives and itch for ≥6 consecutive weeks at any time prior to the Screening, despite the use of non-sedating H1-AHs. Note: Subject must be on a non-sedating H1-AH for treatment of CSU symptoms at the time of the Screening visit.
- UAS7 score ≥16 with a HSS7 score ≥8 for the 2 consecutive weeks prior to randomization (Day 1) while on the stable dose of an H1-AH.
- Be on a stable dose of a single 2nd or later generation H1-antihistamines for the treatment of CSU, between 1× and 4× the licensed dose and frequency, by Day -14 of the Screening Period and must be willing to remain on the same stable dose throughout the study.
- Able and willing to complete a daily electronic diary to collect CSU symptoms for the duration of the study.
- Key
Exclusion
- A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
- Female participants who are pregnant, lactating, or planning to become pregnant during the study.
- Abnormal laboratory values, or findings in physical examination, ECG (QTc \>450 ms for males and \>470 ms for females), or vital signs considered to be clinically significant by the investigator.
- Additionally, a participant will be excluded from Part A, B and D, if:
- • Received treatment with any prescribed (excluding hormonal contraceptives or hormone replacement therapy \[post-menopausal females\]) or nonprescribed systemic or topical medication (including herbal product, and vitamins) within 21 days prior to the first dose of IP (excluding acetaminophen).
- Additionally, a participant will be excluded from Part C, if:
- Has known or suspected urticarial vasculitis
- Subject has causes other than CSU for their urticaria including symptomatic dermographism, cholinergic urticaria, or any inducible urticaria
- Subject has other conditions or diseases that in the investigator's opinion might influence study evaluations and results
- Has any disease or condition (medical or surgical) which, in the opinion of the investigator, or medical monitor, would place the subject at increased risk
Key Trial Info
Start Date :
August 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06072157
Start Date
August 28 2023
End Date
May 12 2025
Last Update
June 3 2025
Active Locations (25)
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1
Site 601-001 Healthy Volunteer Clinical Research Unit (Part A, B and D)
Anniston, Alabama, United States, 36207
2
Site 601-004 (Part C)
Birmingham, Alabama, United States, 35209
3
Site 601-008 (Part C)
Scottsdale, Arizona, United States, 85251
4
Site 601-014 (Part C)
Bakersfield, California, United States, 93301