NCT03379311

A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis

A Phase 1b, Open-Label, Multiple Dose, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Allakos Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b, open-label, study to assess the effects of AK002, given as monthly intravenous infusion for 6 doses at up to 3 mg/kg.

Conditions

• Atopic Keratoconjunctivitis
• Vernal Keratoconjunctivitis
• Perennial Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2018-02-26
• Primary completion: 2019-08-08
• Completion: 2019-08-08
• First posted: 2017-12-20
• Last updated: 2019-08-29

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study