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Monoclonal Antibodies

AK006 for Chronic Urticaria

Phase 1
Recruiting
Research Sponsored by Allakos Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be on a stable dose of a single 2nd or later generation H1-antihistamines for the treatment of CSU, between 1× and 4× the licensed dose and frequency, by Day -14 of the Screening Period and must be willing to remain on the same stable dose throughout the study (Part C only)
Have moderate to severe CSU that is refractory to stable doses of a single 2nd or later generation H1-antihistamines between 1× and 4× the licensed dose and frequency at the time of randomization as defined by the following (Part C Only): Presence of hives and itch for at least 6 consecutive weeks prior to the Screening Visit. Weekly urticaria activity score (UAS7) of at least 16 and weekly hive severity score (HSS7) of at least 8 for the 2 consecutive weeks prior to randomization (Day 1) while on the stable dose of an H1-antihistamines as described above (Note: participant must have completed at least 4 daily Urticaria Patient Daily Diary (UPDD) questionnaires during each of these qualifying weeks to remain eligible for study participation).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 113 (part a and d), day 1 to day 141 (part b) and day 1 to day 197 (part c)
Awards & highlights

Study Summary

This trial studies the safety and effect of a new drug for chronic urticaria. It's a double-blind, placebo-controlled study in healthy and sick people.

Who is the study for?
This trial is for adults with chronic spontaneous urticaria (hives) unresponsive to antihistamines and healthy individuals within specific weight and BMI ranges. Participants must not be pregnant, planning pregnancy, or have significant medical issues. Men in the study must use contraception.Check my eligibility
What is being tested?
The study tests AK006's safety and body response compared to a placebo in people with hives and healthy subjects. It involves single/multiple doses given through IV, exploring how the body processes the drug and its potential effectiveness.See study design
What are the potential side effects?
As this is an early-phase trial for AK006, side effects are being assessed; however, common side effects may include reactions at the injection site, headaches, fatigue, allergic responses or other immune-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of a specific allergy medication for my chronic hives.
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I have severe hives not better with usual allergy pills for over 6 weeks.
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I weigh between 60 and 120 kg and my BMI is between 20 and 32.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 113 (part a and d), day 1 to day 141 (part b) and day 1 to day 197 (part c)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 113 (part a and d), day 1 to day 141 (part b) and day 1 to day 197 (part c) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AEs leading to discontinuation
Incidence and severity of adverse events (AEs)
Incidence of AEs of special interest
+1 more
Secondary outcome measures
AK006 AUC from time 0 extrapolated to infinity (AUC[0-inf])
AK006 AUC over the dosing time interval (time 0 to 28 days) (AUC[tau]) (Part B)
AK006 AUC(0-last) after the second dose (Part B)
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part B - Multiple Ascending Dose (MAD) Intravenous CohortsExperimental Treatment2 Interventions
Part B: Healthy adult participants will receive multiple intravenous infusions of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 3 cohorts evaluated.
Group II: Part A - Single Ascending Dose (SAD) Intravenous CohortsExperimental Treatment2 Interventions
Part A: Healthy adult participants will receive a single intravenous infusion of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 5 cohorts evaluated.
Group III: Cohort D - Single Ascending Dose (SAD) Subcutaneous CohortsExperimental Treatment2 Interventions
Part D: Healthy adult participants will receive a single subcutaneous injection of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 2 cohorts evaluated.
Group IV: Cohort C - Multiple Dose Intravenous CohortExperimental Treatment2 Interventions
Part C: Adults with Chronic Spontaneous Urticaria will receive multiple intravenous infusions of AK006 or matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo-IV
2013
Completed Phase 1
~100
Placebo-SC
2001
Completed Phase 4
~210

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments in healthy subjects, such as vaccines and monoclonal antibodies, work by modulating the immune system. Vaccines stimulate the immune system to recognize and fight pathogens, while monoclonal antibodies target specific proteins or cells to alter immune responses. These mechanisms are important for healthy subjects to understand as they help predict the safety, efficacy, and potential side effects of new treatments like AK006, ensuring informed decision-making and monitoring during clinical trials.
Fluoroquinolones in the management of tuberculous meningitis: Systematic review and meta-analysis.Cancer treatment-related neuropathic pain syndromes--epidemiology and treatment: an update.Frontline therapy in mantle cell lymphoma: the role of high-dose therapy and integration of new agents.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Allakos Inc.Lead Sponsor
16 Previous Clinical Trials
1,384 Total Patients Enrolled
Chin Lee, MDStudy DirectorAllakos Inc.
~93 spots leftby Dec 2025
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