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

Launched by CELLDEX THERAPEUTICS · Aug 31, 2020

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Males and females, 18 - 75 years old.
• 2. 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:
• • 1. Diagnosis of CSU for \>/= 6 months.
• • 2. The presence of itch and hives for \>/= 6 consecutive weeks at any time prior to Visit 1 despite current use of H1-antihistamines.
• • 3. UAS7 of \>/= 16 and HSS7 of \>/= 8 during the 7 days before treatment
• • 4. In-clinic UAS \>/= 4 on one of the screening visit days
• • 5. 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.
• • 3. Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures.
• • 4. Normal blood counts and liver function tests.
• • 5. 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.
• • 6. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
• Key Exclusion Criteria:
• • 1. Women who are pregnant or nursing.
• • 2. Cleary defined cause for chronic urticaria.
• • 3. Known HIV, hepatitis B or hepatitis C infection.
• • 4. 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.
• • 5. History of anaphylaxis.
• • There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.