Coral Gables, FLNCT05677451Now EnrollingIRB Ready

Chronic Urticaria Clinical Trial in Coral Gables, FL

Access cutting-edge chronic urticaria treatment through this clinical trial at a research site in Coral Gables. Study-provided care at no cost to qualified participants.

Sponsored by Novartis Pharmaceuticals

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Expert Care in Coral Gables

Access chronic urticaria specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic urticaria treatment provided free

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Check if you qualify for this chronic urticaria clinical trial in Coral Gables, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Coral Gables

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Coral Gables site if eligible
  4. 4Begin participation

About This Chronic Urticaria Study in Coral Gables

The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment

Sponsor: Novartis Pharmaceuticals

Who Can Participate

Inclusion Criteria

Male and female adolescent participants aged \>= 12 to \< 18 years of age at the time of signing the informed consent
CSU duration for \>= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation)
Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as:
The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines
UAS7 score (range 0 - 42) \>= 16, ISS7 score (range 0 - 21) \>= 6 and HSS7 score (range 0 - 21) \>= 6 during the 7 days prior to randomization (Day 1)
Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants' medical history) Key

Exclusion Criteria

Previous use of remibrutinib or other BTK inhibitors *

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Coral Gables?

Yes, this clinical trial (NCT05677451) has an active research site in Coral Gables, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Urticaria Treatment Options in Coral Gables, FL

If you're searching for chronic urticaria treatment options in Coral Gables, FL, this clinical trial (NCT05677451) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Coral Gables research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic urticaria specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic urticaria clinical trials near you to find additional studies recruiting in your area.

More Chronic Urticaria Trials in Coral Gables, FL

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Secure · Expert Care · Coral Gables, FL