A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria

NCT ID: NCT03436797

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-23
• Study Completion Date: 2020-04-06

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.

Conditions

Chronic Urticaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK002-IV

AK002 given as monthly intravenous infusions at up to 3 mg/kg.

Group Type: EXPERIMENTAL

AK002

Intervention Type: DRUG

AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).

Interventions

AK002

AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).

Intervention Type: DRUG

Eligibility Criteria

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 three 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). 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)

8. No participation in other clinical trials 4 weeks before participation in this study

9. Uncontrolled CU (UCT <12) at the time of enrollment

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 3 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allakos Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henrik Rasmussen, MD, PhD

Role: STUDY_DIRECTOR

Allakos Inc.

Locations

Allakos Investigational Site

Edgewater, Florida, United States

Allakos Investigational Site

Cincinnati, Ohio, United States

Allakos Investigational Site

Berlin, , Germany

Allakos Investigational Site

Mainz, , Germany

Countries

United States; Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AK002-006

Identifier Type: -

Identifier Source: org_study_id