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Monoclonal Antibodies
Lirentelimab for Chronic Urticaria (MAVERICK Trial)
Phase 2
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
Diagnosis of moderate-severe CSU refractory to H1-antihistamine (H1-AH) at a minimum of the licensed dose at the licensed frequency at the time of randomization as defined by the following: presence of hives and itch for ≥6 consecutive weeks prior to Screening Visit 1; UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥8 during the 7 days prior to randomization.
Subjects must be on stable dose of H1-AH, between 1x and 4x of the licensed dose and at the licensed frequency, for treatment of CSU for at least 1 week prior to screening and willing to remain on a stable dose throughout the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
MAVERICK Trial Summary
This trial studies a drug to reduce symptoms of chronic hives, that can't be treated with regular antihistamines. Subjects may continue to use the drug in an extension period.
Who is the study for?
Adults over 18 with chronic spontaneous urticaria (CSU) that hasn't improved with standard antihistamine treatments can join this study. They should not have had a strong reaction to biologic therapies for CSU, be on any other conflicting medications or treatments, or have skin conditions that could affect the trial's results.Check my eligibility
What is being tested?
The trial is testing Lirentelimab (AK002), given as an injection under the skin, against a placebo to see if it helps reduce symptoms of CSU in those who haven't responded well to antihistamines. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment.See study design
What are the potential side effects?
Possible side effects of Lirentelimab may include reactions at the injection site, allergic responses due to its antibody nature, and potentially others not listed here. The exact side effects will be monitored throughout the study.
MAVERICK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe chronic hives not better with standard allergy pills for over 6 weeks.
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I have been on a stable dose of antihistamines for my chronic hives for at least a week.
Select...
I can and will fill out a daily symptom diary and follow the study schedule.
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I have never taken omalizumab or have taken it before.
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I have been diagnosed with chronic spontaneous urticaria for 6 months or more.
MAVERICK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute change in UAS7 at Week 12
Secondary outcome measures
Absolute change in HSS7 at Week 12
Absolute change in ISS7 at Week 12
Proportion of subjects achieving UAS7=0
MAVERICK Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lirentelimab (AK002)Experimental Treatment1 Intervention
Subjects in this arm will receive lirentelimab (AK002) administered subcutaneously.
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
Allakos Inc.Lead Sponsor
16 Previous Clinical Trials
1,397 Total Patients Enrolled
2 Trials studying Chronic Urticaria
187 Patients Enrolled for Chronic Urticaria
Craig Paterson, MDStudy DirectorAllakos Inc.
6 Previous Clinical Trials
740 Total Patients Enrolled
Chin Lee, MD, MPHStudy DirectorAllakos Inc.
1 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used H1-AH medication at doses higher than recommended after my first screening visit.You have had a bad reaction to the study drugs or similar medicines in the past.I understand the study details and have signed the consent form.I haven't had live vaccines recently and will avoid them during the study, except for COVID-19 vaccines.My chronic hives did not improve with biologic therapy.I haven't taken JAK inhibitors in the last 8 weeks.I haven't used specific immune system affecting drugs or treatments in the last 4 weeks.I haven't taken specific allergy or inflammation medicines in the last 3 weeks.I have or might have hereditary angioedema.I have a skin condition causing chronic itch that might affect the study's results.I was diagnosed with a worm infection in the last 6 months and standard treatments didn't work or weren't used.I have severe chronic hives not better with standard allergy pills for over 6 weeks.I have been on a stable dose of antihistamines for my chronic hives for at least a week.I can and will fill out a daily symptom diary and follow the study schedule.I haven't taken any biologic treatments recently.I am currently using biologic medication.I have been diagnosed with or suspected to have urticarial vasculitis.I have never taken omalizumab or have taken it before.I have been diagnosed with chronic spontaneous urticaria for 6 months or more.My hives are not caused by chronic spontaneous urticaria.I am not planning to use any medication that is not allowed in the trial.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Lirentelimab (AK002)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment number for this medical experiment?
"Affirmative. According to clinicaltrials.gov, this medical research is still open for recruitment and was initially published on October 26th 2022 with its most recent update occuring November 17th of the same year. The study requires 110 participants from 3 distinct sites to be recruited."
Answered by AI
Is this experiment presently seeking volunteers?
"As indicated by the clinicaltrials.gov database, this experiment is actively searching for participants and was posted on October 26th 2022 with its most recent update being November 17th 2022."
Answered by AI
To what extent can the administering of Lirentelimab (AK002) be viewed as a risk for patients?
"Due to the Phase 2 nature of this trial, our team at Power has rated Lirentelimab (AK002) a score of two for safety; there is evidence confirming its security but no data demonstrating efficacy."
Answered by AI
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