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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 below
Select...
My condition didn't improve with allergy pills.
Select...
I have been diagnosed with chronic spontaneous urticaria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks of treatment with mepolizumab
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks of treatment with mepolizumab for reporting.

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
3,205 Previous Clinical Trials
3,766,760 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,428 Total Patients Enrolled
Jason C Sluzevich, M.D.Principal InvestigatorStudy Principal Investigator
2 Previous Clinical Trials
19 Total Patients Enrolled

Media Library

Chronic Urticaria Research Study Groups: Treatment Arm

Frequently Asked Questions

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

Are there vacancies left in this medical study that participants can fill?

"Clinicaltrials.gov reports that this medical research is presently in the process of recruiting patients, with a commencement date on July 30th 2019 and last edit taking place November 30th 2022."

Answered by AI

What medical condition does Nucala usually help to alleviate?

"Nucala is commonly prescribed for those suffering from hypereosinophilic syndrome (HES), as well as polyangium, corticosteroid therapy and non-hematologic secondary causes."

Answered by AI

What previous investigations have been conducted regarding the efficacy of Nucala?

"Currently, 15 studies for Nucala are live with 9 trials in the final stage. Although many of them can be found in Bruxelles & Hampshire, there is a total of 751 locations where clinical research concerning this drug is being conducted."

Answered by AI

How many participants will the clinical trial encompass?

"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting participants; the original post was made on 30th July 2019 and last updated on 30th November 2022. Two sites are required for a total of 24 test subjects."

Answered by AI

Is this endeavor a pioneering research effort?

"Research on Nucala began in 2015, when GlaxoSmithKline sponsored the first medical study involving 104 patients. The results of that trial lead to Phase 3 drug approval and currently there are 15 ongoing trials running across 327 cities and 32 nations."

Answered by AI
~4 spots leftby Apr 2025