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Monoclonal Antibodies
Nucala for Chronic Urticaria
Phase < 1
Waitlist Available
Led By Jason C Sluzevich, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unresponsive to oral antihistamine therapy
Clinical and/or histopathological diagnosis of conventional CSU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks of treatment with mepolizumab
Awards & highlights
Study Summary
This trial is testing a new drug to see if it helps people with chronic hives.
Who is the study for?
This trial is for adults over 18 with chronic spontaneous urticaria (hives) that doesn't get better with antihistamines. Participants must be in good health overall and able to follow the study's procedures. Pregnant or nursing women, those planning pregnancy soon, people allergic to Nucala, severe asthma patients on high-dose steroids, and anyone who has used Xolair can't join.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a medication called Nucala (Mepolizumab) for treating chronic spontaneous urticaria when standard treatments like antihistamines don't work. It's an early-stage study aimed at gathering initial data on how well this drug works for hives.See study design
What are the potential side effects?
While not specified here, common side effects of Nucala may include headache, injection site reactions, back pain, fatigue and an allergic reaction to the drug itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition didn't improve with allergy pills.
Select...
I have been diagnosed with chronic spontaneous urticaria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks of treatment with mepolizumab
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks of treatment with mepolizumab
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean UAS score 7
Secondary outcome measures
Mean reduction in ISS and UCT
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
This is an open-label pilot investigation and all study participants are assigned to active treatment. There is no placebo arm in this study.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,239 Previous Clinical Trials
3,771,575 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,764 Previous Clinical Trials
8,104,825 Total Patients Enrolled
Jason C Sluzevich, M.D.Principal InvestigatorStudy Principal Investigator
2 Previous Clinical Trials
19 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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