Trial · NCT02023164

Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria

NCT02023164, Phase 3, Completed, JDP Therapeutics, Inc.; results first posted 2024-02-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria. Trials, record NCT02023164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02023164

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria
NCT number: NCT02023164
Status: Completed
Phases: Phase 3
Enrollment: 36 participants, actual
Lead sponsor: JDP Therapeutics, Inc.
Conditions: Acute Urticaria
Interventions: JDP-205 Injection, Diphenhydramine
First posted: 2013-12-30
Last updated: 2024-02-09
Results first posted: 2024-02-09
Limitations and caveats: This was a pilot Phase 3 study, therefore a description of the statistical analyses was not documented in a separate Statistical Analysis Plan, and instead, are described within the content of the protocol and within the CSR.~The adverse event data were collected in a non-systematic fashion, consisting of adverse events documented as observed by the study site staff and captured based on verbal communication (phone call) to the patient during the follow-up period.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Extent of Urticaria/Erythema Score (Physician Assessment)	Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)	Extent of Urticaria/Erythema Score (Physician Assessment), capturing extent of urticaria/erythema, using the Body Chart (adopted from Burn Chart). Extent of Urticaria/Erythema Score is the average of the 2 scores: 1. Percentage of body area using the body chart (adopted from burn Chart) 0 = none, 1= mild (,25% body coverage), 2 = moderate (25-50% body coverage, 3 = Severe/intense .50% body coverage 2. Intensity of redness (adopted from PASI) 0 = none, 1 = mile (light pink) 2= moderate (pink), 3 =severe/intense (red)
Primary	Physician Pruritus Severity Score	Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first	Physician Pruritus Severity Score based on patient expression of severity of itchiness. 0= none 1 = Mild (patient expresses itchiness but tolerable, and does not scratch 2= moderate definite awareness, bothersome, intermittently scratch affected area 3= severe difficult to tolerate scratch vigorously
Primary	Patient Pruritis Severity Score	Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first	Patient Pruritis Severity Score based on severity of itching at time of assessment. How severly are your hives itching at the moment? 0 = none 1= mild minimal awareness easily tolerated 2 = moderate definite awareness quite bothersome 3= severe difficult to tolerate
Primary	Composite Acute Urticaria Score Change From Baseline	Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)	A composite acute urticaria score, the sum of Extent of urticaria/erythema score (Physician), Physician pruritis score and Patient pruritis severity score. A composite acute urticaria score which the sum of the above three parameters (i.e. 0-9) was calculated post hoc for each patient at each time point and then their score change from the baseline were compared between the two treatment groups. Higher values indicate a worse outcome.
Secondary	Sedation Scores and Time to Readiness for Discharge	Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.	Time from study drug injection to time to readiness for discharge based on composite sedation score at readiness for discharge consist of Physician Sedation Score and Patient Sedation Score Physician Sedation Score Score ranged from 0 to 4 (0=min, 4=max) 0 = None (Patient is completely alert. Does not look tired at all), 1 = Mild (Patient sitting/lying comfortably, and looks tired), 2 = Moderate (Drowsy, with occasional eyes closing), 3 = Severe (Asleep, with eyes closed but responds to minor motor stimulation), 4 = Extremely Severe (Asleep; does not respond to minor motor stimulation) Patient Sedation Score Score ranged from 0 to 4 (0=min, 4=max) 0 = None (Not drowsy at all), 1 = Mild (Slightly drowsy), 2 = Moderate (Quite drowsy), 3 = Severe (Extremely drowsy), 4 = Extremely Severe (Asleep, cannot self-rate) Higher the sedation score = worse outcome A composite sedation score which is the sum of the two parameters.
Secondary	Percentage of Patients Requiring Additional Medication	Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)	Percentage of Patients Requiring Additional Medication (Rescue Medication)
Secondary	Sedation Scores and Time to Readiness for Discharge HH:MM	Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.	Time from study drug injection to time to readiness for discharge based on Physician and Patient Sedation Scores Physician Sedation Score: 0 = None 1 = Mild 2 = Moderate 3= Severe 4 = Extremely Severe Patient Sedation Score 0= None 1- Mild 2 = Moderate 3= Severe 4 = Extremely Severe Higher scores = worse outcome

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Extent of Urticaria/Erythema Score (Physician Assessment)	Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)	Extent of Urticaria/Erythema (Physician Score) 0 = none, 1= mild (patient expresses itchiness, but tolerable and does not scratch, 2 = moderate definite awareness, bothersome, intermittently scratch affected area, 3 = severe difficult to tolerate, scratch vigorously	units on a scale	MEAN
PRIMARY	Physician Pruritus Severity Score	Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first		score on a scale	MEDIAN
PRIMARY	Patient Pruritis Severity Score	Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first	Patient Pruritis Severity Score Some subjects were discharged prior to the 2-hour assessment, resulting in the reduced N at 2 hours.	score on a scale	MEAN
PRIMARY	Composite Acute Urticaria Score Change From Baseline	Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)	33 subjects (100%) completed the following treatment assessments for 1 hour and Discharge 2 hour assessment: 9 participants in the Test Drug Arm/Group and 10 participants in the Control Arm/Group). Some subjects were discharged prior to the 2-hour assessment, resulting in the reduced N at 2 hours.	score on a scale	MEAN
SECONDARY	Sedation Scores and Time to Readiness for Discharge	Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.	A summary of treatment effectiveness as evaluated by the investigators at time of discharge.	score on a scale	MEAN
SECONDARY	Percentage of Patients Requiring Additional Medication	Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)	Subjects who required additional medication. Rescue medication defined as epinephrine, bronchodilators, and steroids usage.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Sedation Scores and Time to Readiness for Discharge HH:MM	Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.	A summary of treatment effectiveness as evaluated by the investigators at time of discharge.	Hours	MEAN

Source ClinicalTrials.gov

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Extent of Urticaria/Erythema Score (Physician Assessment)	Test Drug	Baseline	1.91	Standard Deviation 0.61	units on a scale
Extent of Urticaria/Erythema Score (Physician Assessment)	Control	Baseline	1.74	Standard Deviation 0.89	units on a scale
Extent of Urticaria/Erythema Score (Physician Assessment)	Test Drug	1 Hour	1.53	Standard Deviation 0.74	units on a scale
Extent of Urticaria/Erythema Score (Physician Assessment)	Control	1 Hour	1.12	Standard Deviation 1.05	units on a scale
Extent of Urticaria/Erythema Score (Physician Assessment)	Test Drug	2 Hour	0.89	Standard Deviation 0.60	units on a scale
Extent of Urticaria/Erythema Score (Physician Assessment)	Control	2 Hour	1.35	Standard Deviation 1.03	units on a scale
Extent of Urticaria/Erythema Score (Physician Assessment)	Test Drug	Discharge	1.09	Standard Deviation 0.55	units on a scale
Extent of Urticaria/Erythema Score (Physician Assessment)	Control	Discharge	0.97	Standard Deviation 0.94	units on a scale
Physician Pruritus Severity Score	Test Drug	Baseline Assessment	2.	Full Range 1. to 3.00	score on a scale
Physician Pruritus Severity Score	Control	Baseline Assessment	2.00	Full Range 0.00 to 3.00	score on a scale

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Test Drug	16
Treatment Period	STARTED	Control	17
Treatment Period	COMPLETED	Test Drug	16
Treatment Period	COMPLETED	Control	17
Treatment Period	NOT COMPLETED	Test Drug	0
Treatment Period	NOT COMPLETED	Control	0
24-Hour Follow-Up	STARTED	Test Drug	16
24-Hour Follow-Up	STARTED	Control	17
24-Hour Follow-Up	COMPLETED	Test Drug	16
24-Hour Follow-Up	COMPLETED	Control	15

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events46

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizziness	Nervous system disorders	Test Drug	1	16	1
other	Dizziness	Nervous system disorders	Control	1	17	1
other	Somnolence	Nervous system disorders	Test Drug	1	16	1
other	Somnolence	Nervous system disorders	Control	1	17	1
other	Rash pruritic	Skin and subcutaneous tissue disorders	Test Drug	3	16	3
other	Rash pruritic	Skin and subcutaneous tissue disorders	Control	3	17	3
other	Burning sensation	General disorders	Test Drug	1	16	1
other	Burning sensation	General disorders	Control	1	17	1
other	Constipation	Gastrointestinal disorders	Test Drug	0	16	0
other	Constipation	Gastrointestinal disorders	Control	1	17	1

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Test Drug	0	16
Total, all-cause mortality	Control	0	17
Total, other adverse events	Test Drug	14	16
Total, other adverse events	Control	12	17
Total, serious adverse events	Test Drug	0	16
Total, serious adverse events	Control	0	17

Source ClinicalTrials.gov

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Test Drug vs Control: deaths from any cause	Trial comparisons
Test Drug vs Control: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02023164

GET https://conductscience.org/api/trials/v1/NCT02023164/results?page=2

API reference For AI assistants