Chronic Inducible Urticaria MedDRA version: 23.0 Level: LLT Classification code 10012499 Term: Dermatographic urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: CDX-0159
Product Code: CDX-0159
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: CDX-0159
CAS Number: 2438203-51-9
Current Sponsor code: CDX-0159
Other descriptive name
Sponsors
Celldex Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Males and females, >/= 18 years of age. 2.Diagnosis of ColdU or SD >/= 3 months. 3.Diagnosis of chronic ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by: a.The presence of recurrent pruritic wheals with or without angioedema for >/= 6 weeks at any time prior to Visit 1 despite the use of H1 antihistamines. b.Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment. c.UCT of =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant or nursing. 2.Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD. 3.Active, pruritic skin condition in addition to CIndU. 4.Medical condition that would cause additional risk or interfere with study procedures. 5.Known HIV, hepatitis B or hepatitis C infection. 6.Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine. 7.History of anaphylaxis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of different dose regimens of CDX-0159 compared to placebo, in achieving a negative provocation test in patients with H1AH refractory CIndU in each subtype (ColdU and SD). ;Secondary Objective: •To evaluate efficacy of different dose regimens of CDX-0159 compared to placebo, in improving provocation thresholds and itch triggered by provocation test in each CIndU subtype. •To evaluate efficacy of different dose regimens of CDX-0159 compared to placebo, in achieving a negative provocation test and improving itch triggered by provocation test in combined CIndU patients. •To evaluate the safety profile of different dose regimens of CDX-0159 compared to placebo, in each CIndU subtype, and combined CIndU patients. ;Primary end point(s): •Proportion (%) of patients with a negative provocation test at Week 12 in the ColdU subtype cohort oFor ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min after provocation using TempTest® •Proportion (%) of patients with a negative provocation test at Week 12 in the SD subtype cohort oFor SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min after provocation using the FricTest® ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Mean change from baseline to Week 12 in CTT in the ColdU subtype cohort •Mean change from baseline to Week 12 in CFT in the SD subtype cohort •Mean change from baseline to Week 12 in WI-NRSprovo in the ColdU subtype cohort •Mean change from baseline to Week 12 in WI-NRSprovo in the SD subtype cohort •Proportion (%) of patients with a negative provocation test at Week 12 in the combined CIndU subtype cohorts •Mean change from baseline to Week 12 in WI-NRSprovo in the combined CIndU subtype cohorts •Proportion (%) of patients experiencing TEAEs over the 20-week treatment period by subtype cohort and in the combined CIndU subtype cohorts ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Belgium, Bulgaria, Estonia, Georgia, Germany, Hungary, Latvia, Lithuania, Poland, Serbia, South Africa, Spain, United States
Contacts
Public ContactPhilip Golden
Celldex Therapeutics, Inc.
Outcome results
None listed