Trial Outcomes & Findings for Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria (NCT NCT02023164)

NCT ID: NCT02023164

Last Updated: 2024-02-09

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

36 participants

Primary outcome timeframe

Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)

Results posted on

2024-02-09

Participant Flow

Recruitment of patients who either present to Hospital Emergency Departments, allergy clinics or Urgent Care Centers with acute urticaria, or develop acute urticaria following allergen challenge at an Allergy Clinic.

Participant milestones

Participant milestones
Measure	Test Drug JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Treatment Period STARTED	16	17
Treatment Period COMPLETED	16	17
Treatment Period NOT COMPLETED	0	0
24-Hour Follow-Up STARTED	16	17
24-Hour Follow-Up COMPLETED	16	15
24-Hour Follow-Up NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Drug JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
24-Hour Follow-Up Lost to Follow-up	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Drug n=16 Participants 10 mg/mL, 1 mL JDP-205 Injection	Control n=17 Participants 50 mg/mL, 1 mL Diphenhydramine	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	36 Years STANDARD_DEVIATION 17 • n=5 Participants	39 Years STANDARD_DEVIATION 14 • n=7 Participants	37 Years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Canada	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)

Population: 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

Outcome measures

Outcome measures
Measure	Test Drug n=16 Participants JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control n=17 Participants Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Extent of Urticaria/Erythema Score (Physician Assessment) Baseline	1.91 units on a scale Standard Deviation 0.61	1.74 units on a scale Standard Deviation 0.89
Extent of Urticaria/Erythema Score (Physician Assessment) 1 Hour	1.53 units on a scale Standard Deviation 0.74	1.12 units on a scale Standard Deviation 1.05
Extent of Urticaria/Erythema Score (Physician Assessment) 2 Hour	0.89 units on a scale Standard Deviation 0.60	1.35 units on a scale Standard Deviation 1.03
Extent of Urticaria/Erythema Score (Physician Assessment) Discharge	1.09 units on a scale Standard Deviation 0.55	0.97 units on a scale Standard Deviation 0.94

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Test Drug n=16 Participants JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control n=17 Participants Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Physician Pruritus Severity Score Baseline Assessment	2. score on a scale Interval to 3.0	2.00 score on a scale Interval 0.0 to 3.0
Physician Pruritus Severity Score 1 hour Assessment	1.0 score on a scale Interval 0.0 to 2.0	1. score on a scale Interval 0.0 to
Physician Pruritus Severity Score 2 hour Assessment	1.0 score on a scale Interval 0.0 to 2.0	1.0 score on a scale Interval 0.0 to 2.0
Physician Pruritus Severity Score Discharge Assessment	1.0 score on a scale Interval 0.0 to 2.0	0.0 score on a scale Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first

Population: Patient Pruritis Severity Score Some subjects were discharged prior to the 2-hour assessment, resulting in the reduced N at 2 hours.

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

Outcome measures

Outcome measures
Measure	Test Drug n=16 Participants JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control n=17 Participants Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Patient Pruritis Severity Score Baseline	2.19 score on a scale Standard Deviation 0.66	2.24 score on a scale Standard Deviation 1.03
Patient Pruritis Severity Score 1 Hour	0.56 score on a scale Standard Deviation 0.63	0.82 score on a scale Standard Deviation 1.01
Patient Pruritis Severity Score 2 Hour	0.56 score on a scale Standard Deviation 0.53	0.90 score on a scale Standard Deviation 1.29
Patient Pruritis Severity Score Discharge	0.50 score on a scale Standard Deviation 0.52	0.59 score on a scale Standard Deviation 1.06

PRIMARY outcome

Timeframe: Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Drug n=16 Participants JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control n=17 Participants Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Composite Acute Urticaria Score Change From Baseline 1-Hour Assessment	-3.13 score on a scale Standard Deviation 1.41	-3.26 score on a scale Standard Deviation 2.10
Composite Acute Urticaria Score Change From Baseline 2-Hour Assessment	-4.28 score on a scale Standard Deviation 1.12	-3.65 score on a scale Standard Deviation 2.21
Composite Acute Urticaria Score Change From Baseline Discharge Assessment	-3.81 score on a scale Standard Deviation 1.12	-3.82 score on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.

Population: A summary of treatment effectiveness as evaluated by the investigators at time of discharge.

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.

Outcome measures

Outcome measures
Measure	Test Drug n=16 Participants JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control n=17 Participants Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Sedation Scores and Time to Readiness for Discharge Physician sedation score at Readiness for Discharge	0.19 score on a scale Standard Deviation 0.40	0.35 score on a scale Standard Deviation 0.49
Sedation Scores and Time to Readiness for Discharge Patient sedation score at Readiness for Discharge	0.25 score on a scale Standard Deviation 0.45	0.71 score on a scale Standard Deviation 0.69
Sedation Scores and Time to Readiness for Discharge Composite sedation score at Readiness for Discharge	0.44 score on a scale Standard Deviation 0.81	1.06 score on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)

Population: Subjects who required additional medication. Rescue medication defined as epinephrine, bronchodilators, and steroids usage.

Percentage of Patients Requiring Additional Medication (Rescue Medication)

Outcome measures

Outcome measures
Measure	Test Drug n=16 Participants JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control n=17 Participants Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Percentage of Patients Requiring Additional Medication Rescue Required at Discharge ]Reported by HCP	1 Participants	2 Participants
Percentage of Patients Requiring Additional Medication Additional Rescue Required 24 Hours After Discharged as Reported by Patient	10 Participants	13 Participants

SECONDARY outcome

Timeframe: Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.

Population: A summary of treatment effectiveness as evaluated by the investigators at time of discharge.

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

Outcome measures

Outcome measures
Measure	Test Drug n=16 Participants JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control n=17 Participants Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Sedation Scores and Time to Readiness for Discharge HH:MM	1.65 Hours Standard Deviation 0.53	2.23 Hours Standard Deviation 1.20

Adverse Events

Test Drug

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Executive Director, Clinical Development

TerSera Therapeutics LLC

Phone: 888 600 8116

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Test Drug n=16 participants at risk JDP-205 Injection, 10 mg/mL, 1 mL JDP-205 Injection: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes	Control n=17 participants at risk Diphenhydramine Injection, 50 mg/mL, 1 mL Diphenhydramine: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes
Gastrointestinal disorders Constipation	0.00% 0/16 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Skin and subcutaneous tissue disorders Urticaria	12.5% 2/16 • Number of events 2 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	11.8% 2/17 • Number of events 2 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Skin and subcutaneous tissue disorders Pruritis	18.8% 3/16 • Number of events 3 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Nervous system disorders Headache	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	0.00% 0/17 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Gastrointestinal disorders Abdominal discomfort	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	0.00% 0/17 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Nervous system disorders Sedation	0.00% 0/16 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Gastrointestinal disorders Lip swelling	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	0.00% 0/17 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
General disorders Peripheral swelling	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/16 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Injury, poisoning and procedural complications Injection site pain	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	0.00% 0/17 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Cardiac disorders Tachycardia	0.00% 0/16 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Respiratory, thoracic and mediastinal disorders Tachypnoea	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	0.00% 0/17 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Skin and subcutaneous tissue disorders Rash	25.0% 4/16 • Number of events 4 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	11.8% 2/17 • Number of events 2 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
General disorders Chills	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	0.00% 0/17 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
General disorders Adverse event NOS	0.00% 0/16 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Nervous system disorders Dizziness	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Nervous system disorders Somnolence	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Skin and subcutaneous tissue disorders Rash pruritic	18.8% 3/16 • Number of events 3 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	17.6% 3/17 • Number of events 3 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
General disorders Burning sensation	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Eye disorders Eye swelling	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	0.00% 0/17 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
General disorders Swelling face	0.00% 0/16 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	5.9% 1/17 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)
Respiratory, thoracic and mediastinal disorders Respiration abnormal	6.2% 1/16 • Number of events 1 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)	0.00% 0/17 • Adverse events were collected from time of informed consent through the 24-hour follow-up *after discharge (an average of 36 hours)