A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Study Details
Study Description
Brief Summary
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CDX-0159 CDX-0159 every 4-8 weeks |
Drug: CDX-0159
Administered intravenously
|
| Placebo Comparator: Normal Saline Normal saline every 4-8 weeks |
Drug: Normal Saline
Administered intravenously
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- Pharmacodynamic evaluation [From Day 1 (first dose) to Day 169 (last follow-up visit)]
The change from baseline for Hives Severity Score (HSS7) in patients who received CDX-0159 vs. placebo
- Pharmacodynamic evaluation [From Day 1 (first dose) to Day 169 (last follow-up visit)]
The change from baseline for Itch Severity Score (ISS7) in patients who received CDX-0159 vs. placebo
- Pharmacodynamic evaluation [Day 1 (first dose) to Day 169 (last follow up visit)]
The change in baseline for Urticaria Control Test (UCT) in patients who received CDX-0159 vs. placebo
- Pharmacodynamic evaluation [From Day 1 (before first dose) to Day 169 (last follow-up visit)]
The effect of CDX-0159 on stem cell factor levels
- Pharmacodynamic evaluation [From Day 1 (before first dose) to Day 169 (last follow-up visit)]
The effect of CDX-0159 on tryptase
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Center of Alabama | Birmingham | Alabama | United States | 35209 |
| 2 | Arizona Allergy & Immunology Research | Gilbert | Arizona | United States | 85234 |
| 3 | Sarasota Clinical Research | Sarasota | Florida | United States | 34239 |
| 4 | ForCare Clinical Research | Tampa | Florida | United States | 33613 |
| 5 | Treasure Valley Medical Research | Boise | Idaho | United States | 83706 |
| 6 | Midwest Allergy, Sinus and Asthma, SC Recruiting | Normal | Illinois | United States | 61761 |
| 7 | Dawes Fretzin Clinical Research | Indianapolis | Indiana | United States | 46250 |
| 8 | Kanarek Allergy Asthma & Immunology | Overland Park | Kansas | United States | 66211 |
| 9 | Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | United States | 45231 |
| 10 | Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | United States | 74136-7028 |
| 11 | Asthma, Nasal Disease & Allergy Research Center of New England | East Providence | Rhode Island | United States | 02914 |
| 12 | National Allergy and Asthma Research, LLC | North Charleston | South Carolina | United States | 29420 |
| 13 | AARA Research | Dallas | Texas | United States | 75231 |
| 14 | Charite University | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Celldex Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDX0159-02