A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
NCT ID: NCT04538794
Last Updated: 2023-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2020-09-24
2023-01-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CDX-0159
CDX-0159 every 4-8 weeks
CDX-0159
Administered intravenously
Normal Saline
Normal saline every 4-8 weeks
Normal Saline
Administered intravenously
Interventions
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CDX-0159
Administered intravenously
Normal Saline
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Arizona Allergy & Immunology Research
Gilbert, Arizona, United States
Sarasota Clinical Research
Sarasota, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Midwest Allergy, Sinus and Asthma, SC
Normal, Illinois, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States
Kanarek Allergy Asthma & Immunology
Overland Park, Kansas, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Asthma, Nasal Disease & Allergy Research Center of New England
East Providence, Rhode Island, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, United States
AARA Research
Dallas, Texas, United States
Charite University
Berlin, , Germany
Countries
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Other Identifiers
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2020-005426-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDX0159-02
Identifier Type: -
Identifier Source: org_study_id
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