Clinical trial NCT04538794: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Spontaneous Urticaria
Keywords: CDX-0159
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-09-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety as assessed by the incidence and severity of adverse events
timeFrame: From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary outcomes:
measure: Pharmacokinetic evaluation
timeFrame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
measure: Pharmacodynamic evaluation
timeFrame: From Day 1 (first dose) to Day 169 (last follow-up visit)
measure: Pharmacodynamic evaluation
timeFrame: From Day 1 (first dose) to Day 169 (last follow-up visit)
measure: Pharmacodynamic evaluation
timeFrame: From Day 1 (first dose) to Day 169 (last follow-up visit)
measure: Pharmacodynamic evaluation
timeFrame: Day 1 (first dose) to Day 169 (last follow up visit)
measure: Pharmacodynamic evaluation
timeFrame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
measure: Pharmacodynamic evaluation
timeFrame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
measure: Safety evaluation
timeFrame: From Day 1 (before dosing) to Day 169 (last follow-up visit)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Gilbert
country: United States
facility: Arizona Allergy & Immunology Research
state: Arizona
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Normal
country: United States
facility: Midwest Allergy, Sinus and Asthma, SC
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: Overland Park
country: United States
facility: Kanarek Allergy Asthma & Immunology
state: Kansas
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: East Providence
country: United States
facility: Asthma, Nasal Disease & Allergy Research Center of New England
state: Rhode Island
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC
state: South Carolina
city: Dallas
country: United States
facility: AARA Research
state: Texas
city: Berlin
country: Germany
facility: Charite University
Study officials:
References: