Brief Summary
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
Brief Title
A Study 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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Spontaneous Urticaria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Keywords
CDX-0159
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT04538794
Org Class
Industry
Org Full Name
Celldex Therapeutics
Org Study Id
CDX0159-02
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events
Outcome Measure
Safety as assessed by the incidence and severity of adverse events
Outcome Time Frame
From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary Ids
Secondary Id
2020-005426-29
Secondary Outcomes
Outcome Description
CDX-0159 serum concentrations will be measured at specified visits
Outcome Time Frame
From Day 1 (before first dose) to Day 169 (last follow-up visit)
Outcome Measure
Pharmacokinetic evaluation
Outcome Description
The change from baseline for Urticaria Activity Score (UAS7) in patients who received CDX-0159 vs. placebo
Outcome Time Frame
From Day 1 (first dose) to Day 169 (last follow-up visit)
Outcome Measure
Pharmacodynamic evaluation
Outcome Description
The change from baseline for Hives Severity Score (HSS7) in patients who received CDX-0159 vs. placebo
Outcome Time Frame
From Day 1 (first dose) to Day 169 (last follow-up visit)
Outcome Measure
Pharmacodynamic evaluation
Outcome Description
The change from baseline for Itch Severity Score (ISS7) in patients who received CDX-0159 vs. placebo
Outcome Time Frame
From Day 1 (first dose) to Day 169 (last follow-up visit)
Outcome Measure
Pharmacodynamic evaluation
Outcome Description
The change in baseline for Urticaria Control Test (UCT) in patients who received CDX-0159 vs. placebo
Outcome Time Frame
Day 1 (first dose) to Day 169 (last follow up visit)
Outcome Measure
Pharmacodynamic evaluation
Outcome Description
The effect of CDX-0159 on stem cell factor levels
Outcome Time Frame
From Day 1 (before first dose) to Day 169 (last follow-up visit)
Outcome Measure
Pharmacodynamic evaluation
Outcome Description
The effect of CDX-0159 on tryptase
Outcome Time Frame
From Day 1 (before first dose) to Day 169 (last follow-up visit)
Outcome Measure
Pharmacodynamic evaluation
Outcome Description
Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies
Outcome Time Frame
From Day 1 (before dosing) to Day 169 (last follow-up visit)
Outcome Measure
Safety evaluation
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Denisa Ferastraoaru
Investigator Email
dferastr@montefiore.org
Investigator Phone
866-633-8255