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CDX-0159

Phase 1

Cold Urticaria | Small molecule | Dermatology |Celldex Therapeutics, Inc.|Last Updated: May 17, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04548869A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic UrticariaPHASE1 COMPLETED 41Nov 24, 2020May 12, 2023May 17, 20231 Germany
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Study Endpoints
Primary Endpoints
Safety as assessed by the incidence and severity of adverse events
From Day 1 through week 12

Safety of a single dose of CDX-0159 as determined by adverse events

Secondary Endpoints
For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT)
From Day 1 to Day 85
For patients with Symptomatic Dermographism, change in provocation thresholds
From Day 1 to Day 85
For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)
From Day 1 to Day 85
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CDX-0159EXPERIMENTAL20 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159
Interventions
NameTypeDescription
CDX-0159DRUGAdministered intravenously
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: 1. Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines * Diagnosis for ≥ 3 months; symptoms of both hive (wheal) and itch/burning/painful sensation despite concurrent use of anti-histamines ...

Countries:Germany
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