A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

  • STATUS
    Recruiting
  • End date
    Dec 22, 2021
  • participants needed
    40
  • sponsor
    Celldex Therapeutics
Updated on 22 September 2021
Investigator
Celldex Therapeutics
Primary Contact
Sarasota Clinical Research (7.1 mi away) Contact
+8 other location

Summary

This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.

Description

The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain symptomatic despite treatment with antihistamines.

There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.

Details
Condition Chronic Idiopathic Urticaria, Chronic Spontaneous Urticaria
Treatment Normal saline, CDX-0159
Clinical Study IdentifierNCT04538794
SponsorCelldex Therapeutics
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females, 18 - 75 years old
Diagnosis of chronic spontaneous urticaria (CSU) despite the use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists, as defined by
Diagnosis of CSU for >/= 6 months
The presence of itch and hives for >/= 6 consecutive weeks at any time prior to Visit 1 despite current use of H1-antihistamines
UAS7 of >/= 16 and HSS7 of >/= 8 during the 7 days before treatment
In-clinic UAS >/= 4 on one of the screening visit days
Use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists for at least 3 days immediately prior to study entry and throughout the study
Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures
Normal blood counts and liver function tests
Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment
Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule

Exclusion Criteria

Women who are pregnant or nursing
Cleary defined cause for chronic urticaria
Known HIV, hepatitis B or hepatitis C infection
Vaccination with a live vaccine within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza for injection
History of anaphylaxis
There are additional criteria that your study doctor will review with you to
confirm you are eligible for the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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