A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Study Overview
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Brief Summary
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This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Spontaneous Urticaria

Intervention / Treatment
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* Drug: CDX-0159
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDX-0159<br>CDX-0159 every 4-8 weeks | Drug: CDX-0159<br>* Administered intravenously<br>|
| Placebo Comparator: Normal Saline<br>Normal saline every 4-8 weeks | Drug: Normal Saline<br>* Administered intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic evaluation | CDX-0159 serum concentrations will be measured at specified visits | From Day 1 (before first dose) to Day 169 (last follow-up visit) | 
| Pharmacodynamic evaluation | The change from baseline for Urticaria Activity Score (UAS7) in patients who received CDX-0159 vs. placebo | From Day 1 (first dose) to Day 169 (last follow-up visit) | 
| Pharmacodynamic evaluation | The change from baseline for Hives Severity Score (HSS7) in patients who received CDX-0159 vs. placebo | From Day 1 (first dose) to Day 169 (last follow-up visit) | 
| Pharmacodynamic evaluation | The change from baseline for Itch Severity Score (ISS7) in patients who received CDX-0159 vs. placebo | From Day 1 (first dose) to Day 169 (last follow-up visit) | 
| Pharmacodynamic evaluation | The change in baseline for Urticaria Control Test (UCT) in patients who received CDX-0159 vs. placebo | Day 1 (first dose) to Day 169 (last follow up visit) | 
| Pharmacodynamic evaluation | The effect of CDX-0159 on stem cell factor levels | From Day 1 (before first dose) to Day 169 (last follow-up visit) | 
| Pharmacodynamic evaluation | The effect of CDX-0159 on tryptase | From Day 1 (before first dose) to Day 169 (last follow-up visit) | 
| Safety evaluation | Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies | From Day 1 (before dosing) to Day 169 (last follow-up visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDX-0159