Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria

NCT02935699 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ETTAU-03
• Study Type: interventional
• Target: 262
• Locations: 2 countries
• Sites: 4

Brief Summary

This is a multicenter, parallel group, randomized, double-blind, active controlled, Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent) with acute urticaria requiring treatment.

Conditions

Acute Urticaria

Outcome Measures

Primary Outcomes (1)

• Change of Patient Rated Pruritus Score

  Change from baseline to 2 hours in patient-rated pruritus Severity score (values at 2 hours minus Baseline) Patient Pruritus Severity Score Ask the patient "How severely 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)

  2 hr

Secondary Outcomes (3)

• Number of Patients Who Needed to Return to Treatment Center

  up to 24 hrs

• Time to Discharge

  up to 24 hours

• Patient Sedation Scores

  2 hours

Study Arms (2)

Test Drug

EXPERIMENTAL

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

Drug: Test Drug (JDP-205)

Control

ACTIVE COMPARATOR

Diphenhydramine Injection, 50 mg/mL, 1 mL

Drug: Active Control (Diphenhydramine)

Interventions

Test Drug (JDP-205) DRUG

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

Also known as: QUZYTTIR

Test Drug

Active Control (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

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 who need treatment with antihistamine to alleviate their symptoms;
• years of age or older;
• Be willing and able to give informed consent;
• Patients with a Patient rated Pruritus Severity Score ≥ 1

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 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
• Receipt of an H2 antagonist within the past 2 hours;
• Receipt of doxepin within the past 2 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 4 hours to manage an acute allergic reaction;
• Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes;
• Anaphylaxis prior to the acute anaphylactic symptoms having been treated.
• Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
• Pregnancy or breastfeeding;
• Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication;
• Patients who, based on their medical history or in the opinion of the investigator, have chronic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;
• Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
• History of HIV or other known immunodeficiency;

Sponsors & Collaborators

• JDP Therapeutics, Inc.: lead

Study Sites (4)

Univ of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

City Doc Urgent Care center

Dallas, Texas, 75209, United States

Location

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

• Abella BS, Berger WE, Blaiss MS, Stiell IG, Herres JP, Moellman JJ, Suner S, Kessler A, Klausner HA, Caterino JM, Du J. Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial. Ann Emerg Med. 2020 Oct;76(4):489-500. doi: 10.1016/j.annemergmed.2020.05.025. Epub 2020 Jul 9.

  PMID: 32653333 DERIVED

Related Links

• Sponsor website

MeSH Terms

Interventions

Drug Evaluation; Diphenhydramine

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Medical Affairs
• Organization: TerSera Therapeutics

tersera@medinfodept.com

844-334-4035

Study Officials

• JIE DU, PH.D.

  JDP Therapeutics, Inc.

  STUDY CHAIR

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: October 14, 2016
• First Posted: October 17, 2016
• Study Start: March 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)