Trial · NCT04548869
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
NCT04548869, Phase 1, Completed, Celldex Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria. Trials, record NCT04548869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04548869
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
- NCT number
- NCT04548869
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 41 participants, actual
- Lead sponsor
- Celldex Therapeutics
- Conditions
- Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism, Symptomatic Dermatographism, Cholinergic Urticaria
- Interventions
- CDX-0159
- First posted
- 2020-09-16
- Last updated
- 2023-05-17
- Other registries' IDs
- eudract:2020-002792-35
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT) | From Day 1 to Day 85 | The change from baseline in critical temperature thresholds over time as determined by provocation testing using the TempTest® |
| Secondary | For patients with Symptomatic Dermographism, change in provocation thresholds | From Day 1 to Day 85 | The change from baseline in provocation thresholds over time as determined by provocation testing using the FricTest® |
| Secondary | For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo) | From Day 1 to Day 85 | Changes from baseline and percentage of responders as measured by UASprovo |
| Secondary | Changes from baseline in Urticaria Control Test (UCT) | From Day 1 to Day 85 | Changes from baseline and percentage of responders for the UCT and modified UCT |
| Secondary | Blood Biomarkers | From Day 1 to Day 85 | Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in Stem Cell Factor |
| Secondary | Blood Biomarkers | From Day 1 to Day 85 | Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in tryptase |
| Secondary | Pharmacokinetic Evaluation | From Day 1 to Day 85 | CDX-0159 concentrations will be measured. |
| Secondary | Immunogenicity Evaluation | From Day 1 to Day 85 | Patients will be monitored for the development of anti-drug antibodies. |
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/NCT04548869
GET https://conductscience.org/api/trials/v1/NCT04548869/registered