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

NCT03436797 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AK002-006
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 4

Brief Summary

This is a Phase 2a, open-label study to assess the effects of AK002

Conditions

Chronic Urticaria

Outcome Measures

Primary Outcomes (1)

• Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the 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 \[MCID\]).

  Baseline to Week 22 (Main Study Phase)

Other Outcomes (1)

• Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase

  Through study completion, up to 52 weeks (Extension Dosing Phase)

Study Arms (1)

AK002-IV

EXPERIMENTAL

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

Drug: AK002

Interventions

AK002 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).

AK002-IV

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Receipt of intravenous IgG therapy 30 days prior to Baseline
• Plasmapheresis 30 days prior to Baseline
• Use (daily or every other day) of Doxepin 14 days prior to Baseline
• Receipt of inactive vaccination or live attenuated vaccine 30 days prior to Baseline
• Use of H2 antihistamines 7 days before Baseline

Sponsors & Collaborators

• Allakos Inc.: lead

Study Sites (4)

Allakos Investigational Site

Edgewater, Florida, 32132, United States

Location

Allakos Investigational Site

Cincinnati, Ohio, 45231, United States

Location

Allakos Investigational Site

Berlin, 10117, Germany

Location

Allakos Investigational Site

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

AK002

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Information
• Organization: Allakos

medinfo@allakos.com

650-597-5002

Study Officials

• Henrik Rasmussen, MD, PhD

  Allakos Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 19, 2018
• Study Start: January 23, 2018
• Primary Completion: November 21, 2018
• Study Completion: April 6, 2020
• Last Updated: March 4, 2024
• Results First Posted: January 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); DE (2)