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

NCT02023164 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: ETTAU-02CTN-P4-427
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 6

Brief Summary

This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.

Conditions

Acute Urticaria

Keywords

urticaria; allergic reaction; cetirizine; JDP-205

Outcome Measures

Primary Outcomes (4)

• Extent of Urticaria/Erythema Score (Physician Assessment)

  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)

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

• Physician Pruritus Severity Score

  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

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

• Patient Pruritis Severity Score

  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

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

• Composite Acute Urticaria Score Change From Baseline

  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.

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

Secondary Outcomes (3)

• 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.

• Percentage of Patients Requiring Additional Medication

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

• 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.

Study Arms (2)

Test Drug

EXPERIMENTAL

JDP-205 Injection, 10 mg/mL, 1 mL

Drug: JDP-205 Injection

Control

ACTIVE COMPARATOR

Diphenhydramine Injection, 50 mg/mL, 1 mL

Drug: Diphenhydramine

Interventions

JDP-205 Injection DRUG

Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes

Also known as: Cetirizine, Quzyttir

Test Drug

Diphenhydramine DRUG

Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes

Also known as: Benadryl, DPH

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with a diagnosis of acute urticaria associated with an acute allergic reaction to a known (e.g. food, medication, insect bites) or unknown allergen who need treatment with an injectable antihistamine to alleviate their symptoms;
• years of age or older;
• Be willing and able to give informed consent;
• Patients with a Physician Pruritus Severity Score ≥ 1 (determined by the investigator);
• Patients with an Extent of Urticaria/Erythema Score ≥ 1 (determined by the investigator).

You may not qualify if:

• Receipt of an investigational drug or device, within the past 30 days;
• Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);
• Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;
• Receipt of any antihistamine (H1 antagonist) within the past 4 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
• Receipt of an H2 antagonist within the past 12 hours;
• Receipt of doxepin within the past 48 hours; doxepin is an antidepressant, but it also has antihistamine properties;
• Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 48 hours to manage an acute allergic reaction;
• Receipt of epinephrine (EpiPen or any other brand) within the past 1 hour;
• Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
• Pregnancy or breastfeeding;
• Patients who require epinephrine immediately to manage their acute allergic symptoms;
• Patients who have an acute reaction to medication they are taking (e.g. antibiotics, ACE inhibitors, NSAIDs) and who cannot stop the medication;
• Patients who, based on their medical history or in the opinion of the investigator, have chronic idiopathic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;
• Urticaria not associated with an acute allergic reaction;
• Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;

Sponsors & Collaborators

• JDP Therapeutics, Inc.: lead

Study Sites (6)

University of Cincinnati, Department of Emergency Medicine

Cincinnati, Ohio, 45267-0769, United States

Location

OSU Hospitals, Department of Emergency Medicine

Columbus, Ohio, 43210, United States

Location

Glengarry Memorial Hospital, Independent Practice

Alexandria, Ontario, Canada

Location

Ottawa Hospital, Civic Campus

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Del Carpio Independent Practice

Montreal, Quebec, H3G 1L5, Canada

Location

MeSH Terms

Conditions

Urticaria; Hypersensitivity

Interventions

Cetirizine; Diphenhydramine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

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.

Results Point of Contact

• Title: Executive Director, Clinical Development
• Organization: TerSera Therapeutics LLC

jnorth@tersera.com

888 600 8116

Study Officials

• Janine North, B.S.

  TerSera Therapeutics LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 30, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 9, 2024
• Results First Posted: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); US (2)