Back to resultsA Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Primary Purpose
Chronic Spontaneous Urticaria
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CDX-0159
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring CDX-0159
Eligibility Criteria
Key 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.
Key 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.
Sites / Locations
- Clinical Research Center of Alabama
- Arizona Allergy & Immunology Research
- Sarasota Clinical Research
- ForCare Clinical Research
- Treasure Valley Medical Research
- Midwest Allergy, Sinus and Asthma, SC
- Dawes Fretzin Clinical Research
- Kanarek Allergy Asthma & Immunology
- Bernstein Clinical Research Center, LLC
- Vital Prospects Clinical Research Institute, PC
- Asthma, Nasal Disease & Allergy Research Center of New England
- National Allergy and Asthma Research, LLC
- AARA Research
- Charite University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CDX-0159
Normal Saline
Arm Description
CDX-0159 every 4-8 weeks
Normal saline every 4-8 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharmacokinetic evaluation
CDX-0159 serum concentrations will be measured at specified visits
Pharmacodynamic evaluation
The change from baseline for Urticaria Activity Score (UAS7) in patients who received CDX-0159 vs. placebo
Pharmacodynamic evaluation
The change from baseline for Hives Severity Score (HSS7) in patients who received CDX-0159 vs. placebo
Pharmacodynamic evaluation
The change from baseline for Itch Severity Score (ISS7) in patients who received CDX-0159 vs. placebo
Pharmacodynamic evaluation
The change in baseline for Urticaria Control Test (UCT) in patients who received CDX-0159 vs. placebo
Pharmacodynamic evaluation
The effect of CDX-0159 on stem cell factor levels
Pharmacodynamic evaluation
The effect of CDX-0159 on tryptase
Safety evaluation
Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04538794
Brief Title
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
January 17, 2023 (Actual)
Study Completion Date
January 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
Keywords
CDX-0159
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDX-0159
Arm Type
Experimental
Arm Description
CDX-0159 every 4-8 weeks
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal saline every 4-8 weeks
Intervention Type
Drug
Intervention Name(s)
CDX-0159
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Safety as assessed by the incidence and severity of adverse events
Description
Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events
Time Frame
From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary Outcome Measure Information:
Title
Pharmacokinetic evaluation
Description
CDX-0159 serum concentrations will be measured at specified visits
Time Frame
From Day 1 (before first dose) to Day 169 (last follow-up visit)
Title
Pharmacodynamic evaluation
Description
The change from baseline for Urticaria Activity Score (UAS7) in patients who received CDX-0159 vs. placebo
Time Frame
From Day 1 (first dose) to Day 169 (last follow-up visit)
Title
Pharmacodynamic evaluation
Description
The change from baseline for Hives Severity Score (HSS7) in patients who received CDX-0159 vs. placebo
Time Frame
From Day 1 (first dose) to Day 169 (last follow-up visit)
Title
Pharmacodynamic evaluation
Description
The change from baseline for Itch Severity Score (ISS7) in patients who received CDX-0159 vs. placebo
Time Frame
From Day 1 (first dose) to Day 169 (last follow-up visit)
Title
Pharmacodynamic evaluation
Description
The change in baseline for Urticaria Control Test (UCT) in patients who received CDX-0159 vs. placebo
Time Frame
Day 1 (first dose) to Day 169 (last follow up visit)
Title
Pharmacodynamic evaluation
Description
The effect of CDX-0159 on stem cell factor levels
Time Frame
From Day 1 (before first dose) to Day 169 (last follow-up visit)
Title
Pharmacodynamic evaluation
Description
The effect of CDX-0159 on tryptase
Time Frame
From Day 1 (before first dose) to Day 169 (last follow-up visit)
Title
Safety evaluation
Description
Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies
Time Frame
From Day 1 (before dosing) to Day 169 (last follow-up visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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.
Key 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.
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Arizona Allergy & Immunology Research
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Midwest Allergy, Sinus and Asthma, SC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Dawes Fretzin Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Kanarek Allergy Asthma & Immunology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-7028
Country
United States
Facility Name
Asthma, Nasal Disease & Allergy Research Center of New England
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
National Allergy and Asthma Research, LLC
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
AARA Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Charite University
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
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