Chronic Spontaneous Urticaria
Conditions
Keywords
CDX-0159
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.
Interventions
DRUGNormal Saline
Administered intravenously
DRUGCDX-0159
Administered intravenously
Sponsors
Celldex Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by the incidence and severity of adverse events | From Day 1 (first dose) to Day 169 (last follow-up visit) | Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic evaluation | From Day 1 (before first dose) to Day 169 (last follow-up visit) | CDX-0159 serum concentrations will be measured at specified visits |
| Pharmacodynamic evaluation | From Day 1 (first dose) to Day 169 (last follow-up visit) | The change from baseline for Urticaria Activity Score (UAS7) in patients who received CDX-0159 vs. placebo |
| Safety evaluation | From Day 1 (before dosing) to Day 169 (last follow-up visit) | Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies |
Countries
Germany, United States
Outcome results
None listed