A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients With Chronic Spontaneous Urticaria
2 other identifiers
interventional
45
2 countries
14
Brief Summary
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2020
Typical duration for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 4, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2023
CompletedJuly 19, 2023
July 1, 2023
2.3 years
August 31, 2020
July 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety as assessed by the incidence and severity of adverse events
Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events
From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary Outcomes (8)
Pharmacokinetic evaluation
From Day 1 (before first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
Day 1 (first dose) to Day 169 (last follow up visit)
- +3 more secondary outcomes
Study Arms (2)
CDX-0159
EXPERIMENTALCDX-0159 every 4-8 weeks
Normal Saline
PLACEBO COMPARATORNormal saline every 4-8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Arizona Allergy & Immunology Research
Gilbert, Arizona, 85234, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Midwest Allergy, Sinus and Asthma, SC
Normal, Illinois, 61761, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250, United States
Kanarek Allergy Asthma & Immunology
Overland Park, Kansas, 66211, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136-7028, United States
Asthma, Nasal Disease & Allergy Research Center of New England
East Providence, Rhode Island, 02914, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420, United States
AARA Research
Dallas, Texas, 75231, United States
Charite University
Berlin, 10117, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 4, 2020
Study Start
September 24, 2020
Primary Completion
January 17, 2023
Study Completion
January 17, 2023
Last Updated
July 19, 2023
Record last verified: 2023-07