An Open-Label, Pilot Study to Assess the Efficacy and Safety of AK002 (Siglec-8) in Subjects With Antihistamine-Resistant Chronic Urticaria
Overview
- Phase
- Phase 2
- Intervention
- AK002
- Conditions
- Chronic Urticaria
- Sponsor
- Allakos Inc.
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a Phase 2a, open-label study to assess the effects of AK002
Detailed Description
This open-label study is to assess the effects of AK002, given as monthly intravenous infusions at up to 3 mg/kg. A total of 47 patients will be enrolled across 2-4 sites. All patients enrolled in the study will receive 6 monthly infusions of AK002 and will then be followed for another 8 weeks. Some patients will have the option to receive an additional 12 months of extended dosing.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (≥ 18 and ≤ 85 years old)
- •Body weight \<125 Kg
- •Informed consent signed and dated
- •Able to read, understand, and willing to sign the informed consent form and comply with study procedures
- •Diagnosis of CU for at least three months, refractory to antihistamine treatment in single or 4-fold dosage
- •Willing, committed, and able to return for all clinic visits and complete all study-related procedures, including willingness to have IV infusion of study drug administered by a qualified person
- •Females of childbearing potential must have a negative pregnancy test at Baseline. Female subjects must be willing to use highly effective contraception (Pearl- 4 Index \< 1). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years (FSH \>40mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
- •No participation in other clinical trials 4 weeks before participation in this study
- •Uncontrolled CU (UCT \<12) at the time of enrollment
Exclusion Criteria
- •Acute urticaria
- •Concurrent/ongoing treatment with immunosuppressives (e.g., cyclosporine, methotrexate, dapsone, or others) within 4 weeks or 5 half-lives prior to Baseline, whichever is longer
- •Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- •Significant concomitant illness that would adversely affect the subject's participation or evaluation in this study
- •History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
- •Presence of clinically significant laboratory abnormalities
- •Lactating women or pregnant women
- •Substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject's ability to comply with study procedures
- •Subjects who are detained officially or legally to an official institute or those that have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities will be excluded from the study
- •Use of omalizumab within the last 3 months
Arms & Interventions
AK002-IV
AK002 given as monthly intravenous infusions at up to 3 mg/kg.
Intervention: AK002
Outcomes
Primary Outcomes
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase
Time Frame: Baseline to Week 22 (Main Study Phase)
The UCT score consists of 4 items, and each UCT item has 5 answer options (scored with 0-4 points), where low points indicate high disease activity and low disease control of chronic urticaria. The UCT score, ranging from 0 to 16, is calculated by adding all 4 individual item scores. A UCT score of 16 points indicates complete disease control and a change of the UCT score of 3 or more points was regarded as clinically relevant (minimal clinically important difference \[MCID\]).