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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 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)

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)

+10 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

0 / 3Eligibility criteria met

Find a Location

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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to partake in this trial?

"The criteria for enrolling in this clinical trial requires subjects to be of sound health and aged between 18-65. In total, 124 participants are expected."

Answered by AI

What is the current participant cap of this clinical trial?

"Indeed, the clinicaltrials.gov website reveals that this research is looking for participants to join the trial; it was inaugurated on August 28th 2023 and last updated on October 2nd of the same year. The study requires 124 volunteers from a single medical centre."

Answered by AI

Are there any unfilled positions available in this trial?

"Affirmative. The clinicaltrials.gov entry for this trial indicates that it is actively recruiting participants, starting from August 28th 2023 and last updated on October 2nd 2023. This medical study requires 124 patients to be recruited from 1 centre."

Answered by AI

Does the FDA sanction Part A - Single Ascending Dose (SAD) Cohorts?

"As this is a Phase 1 trial, meaning there is scant clinical data to support its safety and effectiveness, our team at Power gave Part A - Single Ascending Dose (SAD) Cohorts a score of 1."

Answered by AI

Is eligibility for this trial contingent upon a specific age range?

"According to the guidelines, individuals aged 18 through 65 are eligible for participation in this medical trial. For those under 18 and over 65 years of age, there are 70 trials and 426 trials respectively available for their consideration."

Answered by AI

What is the stated purpose of this clinical experiment?

"Allakos Inc., the study sponsor, has specified that the primary outcome to be measured over a Screening - Day 113 (Part A) and Screening-Day 141 (Part B and C) duration is Adverse Events of Special Interest. Furthermore, secondary objectives include AK006 Area Under Concentration Time Curve from 0 to Last Quantifiable Concentration (AUC[0-last]), AK006 AUC From Zero Extrapolated To Infinity (AUC[0-inf]) as well as Total Systemic Clearance of AK006 after Intravenous Dose(CL)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria

2023. "Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072157.

All > Chronic Spontaneous Urticaria