Your session is about to expire
← Back to Search
Monoclonal Antibodies
AK006 for Chronic Urticaria
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 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).
Must not have
Female participants who are pregnant, lactating, or planning to become pregnant during the study.
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)
Summary
This trial tests a new drug, AK006, given either directly into the bloodstream or just under the skin. It involves healthy people and those with chronic spontaneous urticaria, a condition with frequent hives. Researchers aim to see how the body handles the drug and if it causes any immune reactions.
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.
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.
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 belowSelect...
I have been on a stable dose of a specific allergy medication for my chronic hives.
Select...
I have severe hives not better with usual allergy pills for over 6 weeks.
Select...
I weigh between 60 and 120 kg and my BMI is between 20 and 32.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AEs leading to discontinuation
Incidence and severity of adverse events (AEs)
Incidence of AEs of special interest
+1 moreSecondary study objectives
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 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part 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 II: Part C - Multiple Dose Intravenous CohortExperimental Treatment2 Interventions
Part C: Adults with Chronic Spontaneous Urticaria will receive multiple intravenous infusions of AK006 or matching placebo.
Group III: 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 IV: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo-IV
2013
Completed Phase 1
~220
Placebo-SC
2023
Completed Phase 4
~360
AK006-IV
2023
Completed Phase 1
~150
AK006-SC
2023
Completed Phase 1
~150
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.
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.
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Allakos Inc.Lead Sponsor
17 Previous Clinical Trials
1,445 Total Patients Enrolled
Chin Lee, MDStudy DirectorAllakos Inc.