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Oral add on treatment for Chronic Spontaneous Urticaria

The purpose of this study is to evaluate efficacy of an investigational oral medication (remibrutinib) compared to injection medication (dupilumab) when administered as an add-on treatment to antihistamines in adult US participants with moderate to severe chronic spontaneous urticaria inadequately controlled.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet with a member of the study team and fill out questionnaires. The study also involves twice daily eDiaries, signs, blood draws, urine testing, ECGs, physical exams, willingness to provide medical history and use of medications, use of birth control method if applicable, and willingness to take the study medication as directed.

Incentives

Information provided upon request

In-person visits:
8

Phone or online visits:
2

Total length of participation:
6 months

Looking for Specific Volunteers

Able to participate:

you are 18 years or older
you have a diagnosis of Chronic Spontaneous Urticaria for at least 6 months before the first visit.
your diagnosis is inadequately controlled by antihistamines
you are willing to complete a daily diary for the duration of the study

Not eligible if:

have participated in another clinical trial within the last 30 days
have used remibrutinib or dupilumab in the past
have a history of lymphoproliferative disease or any malignancy
are pregnant or breastfeading

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Dermatology and Skin Cancer Center at Southern Village
410 Market St Ste 400, Chapel Hill, NC 27516, USA

Additional Study Information

Principal Investigator

Donna Culton
Dermatology-Research

Study Type

Clinical or Medical
Interventional

Study Topics

Skin, Hair, and Nails

IRB Number

25-1646

ClinicalTrials.gov

NCT06868212

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Questions?

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