Trial · NCT05405660
A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
NCT05405660, Phase 2, Completed, Celldex Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of CDX-0159 in Patients With Chronic Inducible Urticaria. Trials, record NCT05405660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05405660
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
- NCT number
- NCT05405660
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 196 participants, actual
- Lead sponsor
- Celldex Therapeutics
- Conditions
- Chronic Inducible Urticaria
- Interventions
- barzolvolimab, Matching Placebo
- First posted
- 2022-06-06
- Last updated
- 2025-11-06
- Other registries' IDs
- eudract:2021-006447-95
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients with a negative provocation test at week 12 | From baseline to week 12 | Percentage of patients with a negative provocation test for Cold Inducible Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) at week 12 * 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® * 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 | Change in provocation threshold and itch for ColdU | From baseline to week 12 | Mean change from baseline to week 12 in critical temperature threshold (CTT) in patients with ColdU CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute mark |
| Secondary | Change in provocation threshold for SD | From baseline to week 12 | Mean change from baseline to Week 12 in Critical Friction Threshold (CFT) in patients with SD CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute mark |
| Secondary | Change in worst itch reported after provocation for ColdU | From baseline to week 12 | Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with ColdU |
| Secondary | Combined patients with a negative provocation test at week 12 | From baseline to week 12 | Percentage of combined patients with a negative TempTest (ColdU) or FricTest (SD) at week 12 |
| Secondary | Change in worst itch reported after provocation for SD | From baseline to week 12 | Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD |
| Secondary | Change in worst itch reported after provocation in both SD and ColdU | From baseline to week 12 | Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD and ColdU combined |
| Secondary | Percentage of patients experiencing adverse events | From baseline to week 20 | Percentage of patients experiencing treatment-emergent adverse events (TEAE) examined by ColdU patients, SD patients and in combination. A TEAE is any untoward medical occurrence in a patient administered a study treatment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05405660
GET https://conductscience.org/api/trials/v1/NCT05405660/registered