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AK006-001 Enrolling

Chronic Spontaneous Urticaria Study (23 Weeks)


Treatment: IV Age: 18 Years


Who Can Participate?

Adults of any sex/gender (from 18 to 65 years of age) with chronic spontaneous urticaria (CSU) may participate.

Inclusion Criteria:

        • CSU for 6 months or more
        • Weigh between 60-120kg (132-264lbs)
        • Body mass index (BMI) between 20-32kg/m2*
        • No history of severe allergic reaction to drugs or foods, or a history of anaphylactic reaction
        • Not currently using any biologics to treat any indication

* Divide your weight in kilograms by your height in meters to calculate

Why Participate?

      • No cost to participate or receive treatment
      • Regular visits with study doctors who specialize in treating CSU (11 visits)
      • Will receive either an investigative infusion treatment (study drug) or a placebo
      • Reimbursement for study-related expenses may be provided

How Long Will The Study Last?

      • 23 weeks

Note: Participants will need to refrain from using CBD products for the duration of the study


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Vipul Jain

allergist

Dr. Wei Jing Loo

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

Official Title

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Sequential, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AK006 in Healthy Subjects and in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria

ClinicalTrials.gov ID

NCT06072157

Sponsor

Allakos Inc.

Study Description

  • 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 of intravenous (IV) infusions and a single subcutaneous (SC) injection of AK006. The study will be conducted in 4 parts: a single-ascending dose part (Part A) in healthy participants, a multiple-ascending dose part (Part B) in healthy participants with an expanded cohort (Part C) in participants with chronic spontaneous urticaria (CSU), and a single ascending dose SC injection cohort (Part D) in healthy participants.

  • Condition or Disease:

    Healthy Participants

  • Intervention/Treatment:

    Drug: AK006-IV
    Drug: AK006-IV
    Drug: AK006-IV
    Drug: AK006-SC
  • Phase:

    Phase 1

  • Ages Eligible for Study:

    18 Years and 65 Years (Adult)

  • Sexes Eligible for Study:

    All

Key Inclusion Criteria:

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 Criteria: 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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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