Skip to content

CDX0159-07: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose ranging Study to Assess the Efficacy and Safety of CDX 0159 in Patients with Chronic Inducible Urticaria

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516988-87-00
Acronym
CDX0159-07
Enrollment
114
Registered
2024-11-13
Start date
2022-11-09
Completion date
2025-09-12
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inducible Urticaria

Brief summary

Proportion (%) of patients with a negative provocation test at Week 12 in the ColdU subtype cohort (X) For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest®, Proportion (%) of patients with a negative provocation test at Week 12 in the SD subtype cohort (X) For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®

Detailed description

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

Interventions

Sponsors

Celldex Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion (%) of patients with a negative provocation test at Week 12 in the ColdU subtype cohort (X) For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest®, Proportion (%) of patients with a negative provocation test at Week 12 in the SD subtype cohort (X) For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®

Secondary

MeasureTime frame
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

Countries

Bulgaria, Germany, Hungary, Latvia, Lithuania, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026