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A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria

NCT05528861 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2024-09-27

Study results available
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Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 6 doses of subcutaneous lirentelimab.

Conditions

Interventions

DRUG

Lirentelimab (AK002)

Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Allakos Inc.

    lead INDUSTRY

Principal Investigators

  • Chin Lee, MD, MPH · Allakos Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2023-12-27
Completion
2024-04-18
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05528861 on ClinicalTrials.gov