Trial · NCT02171416
Cold Contact Urticaria Treatment With Rilonacept
NCT02171416, Phase 2, Completed, Charite University, Berlin, Germany
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cold Contact Urticaria Treatment With Rilonacept. Trials, record NCT02171416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02171416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cold Contact Urticaria Treatment With Rilonacept
- NCT number
- NCT02171416
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Charite University, Berlin, Germany
- Conditions
- Cold Contact Urticaria
- Interventions
- Rilonacept, Placebo
- First posted
- 2014-06-24
- Last updated
- 2018-07-17
- Other registries' IDs
- eudract:2012-005726-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the effect of rilonacept on the clinical signs and symptoms of CCU | 6 weeks | Change in symptom development (critical temperature thresholds (CTT) in CCU patients from baseline to day 42 in the rilonacept group as compared to the placebo group |
| Secondary | To assess the safety of rilonacept in subjects with CCU | 6 weeks | This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting |
| Other | Change in the patient's quality of life | 6 weeks | Assessed by the Dermatology Life Quality Index (DLQI) from baseline to day 42 in the rilonacept group as compared to the placebo group and from baseline to the open-label treatment with rilonacept |
| Other | Differences in mast cell mediator release | 6 weeks | Measured in the blood of CCU patients during the challenge with cold water at day 42 in the rilonacept group as compared to the placebo group and during the open-label treatment in the rilonacept 160 mg group as compared to the 320 mg group |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36973954 | DERIVED |
Source PubMed
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/NCT02171416
GET https://conductscience.org/api/trials/v1/NCT02171416/registered