A Phase 2, open-label study to assess the efficacy and safety of AK002 in patients with chronic urticaria who do not respond to anithistamines

Phase 1

• Conditions: Patients with different types of chronic urticaria resistant to standard dose antihistamines; MedDRA version: 20.0Level: PTClassification code 10052568Term: Urticaria chronicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-002581-51-DE
• Lead Sponsor: Allakos Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-19
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1) Adults (= 18 and = 85 years old)
2) Body weight <125 Kg
3) Informed consent signed and dated
4) Able to read, understand, and willing to sign the informed consent form and comply with study procedures
5) Diagnosis of CU for at least 3 months, refractory to antihistamine treatment in single or 4-fold dosage
6) 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
7) 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) or abstain from sexual activity from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer. A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years (FSH >40 mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from Screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
8) No participation in other clinical trials 4 weeks before participation in this study
9) Uncontrolled CU (UCT <12) at the time of enrollment
10) For extended dosing, subjects must have a baseline (Day 1) UCT of =5 and a week 22 (Day 155) UCT of = 12 (Complete Response). They must have a UCT of =5 post-week 22 (Day 155) and by week 44 (Day 309) i.e., within 6 months from last dose
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1) Acute urticaria
2) 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
3) Significant medical condition rendering the patient
immunocompromised or not suitable for a clinical trial
4) Significant concomitant illness that would adversely affect the
subject’s participation or evaluation in this study
5) 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
6) Presence of clinically significant laboratory abnormalities
7) Lactating women or pregnant women
8) 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
9) 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
10) Use of omalizumab within the last 2 months
11) Receipt of intravenous IgG therapy 30 days prior to Baseline
12) Plasmapheresis 30 days prior to Baseline
13) Use (daily or every other day) of Doxepin 14 days prior to Baseline
14) Receipt of inactive vaccination or live attenuated vaccine 30 days
prior to Baseline
15) Use of H2 antihistamines 7 days before Baseline
16) Intake of leukotriene antagonists within 7 days prior to enrollment
17) Intake of systemic corticosteroids (e.g., oral or depot) within 14
days prior to enrollment
18) Positive screening for ova and parasite test at Baseline
19) Treatment of helminthic parasite within 6 months of screening
20) Positive HIV serology at screening
21) Positive Hepatitis serology at baseline, except for vaccinated
patients or patients with past but resolved hepatitis at screening
22) Donation or loss of >500ml of blood within 56 days prior to
administration of study drug or donation of plasma within 7 days
prior to administration of drug
23) Known hypersensitivity to any ingredients of AK002 or drugs
related to AK002 (e.g., monoclonal antibodies, polyclonal gamma
globulin)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified