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Monoclonal Antibodies

AK006 IV for Hives

Phase 1
Waitlist Available
Research Sponsored by Allakos Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 30 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is an extension study for people with Chronic Spontaneous Urticaria who have already completed the main part of the study. Participants will receive up to four doses of the study drug through

Who is the study for?
This trial is for people who have chronic spontaneous urticaria (hives) that doesn't get better with antihistamines and have completed the main part of study AK006-001. Participants will receive additional treatment.
What is being tested?
The trial tests further doses of a drug called AK006 given through an IV every four weeks, up to four times. After treatments, there's a 16-week period where patients are checked for how well they tolerate the drug and its effectiveness.
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar drugs include reactions at the infusion site, headaches, fatigue, and possible allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 30 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
AK006 Anti-drug Antibodies (ADAs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 720mg of AK006 IVExperimental Treatment1 Intervention
Subjects in this arm will receive 4 doses of 720mg of AK006 via intravenous infusion every 4 weeks.

Find a Location

Who is running the clinical trial?

Allakos Inc.Lead Sponsor
17 Previous Clinical Trials
1,533 Total Patients Enrolled
3 Trials studying Chronic Urticaria
322 Patients Enrolled for Chronic Urticaria
Chin Lee, MD, MPHStudy DirectorAllakos Inc.
2 Previous Clinical Trials
258 Total Patients Enrolled
1 Trials studying Chronic Urticaria
127 Patients Enrolled for Chronic Urticaria
~38 spots leftby Aug 2025
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