Norketotifen for the Treatment of Uncomplicated Influenza-like Illness

A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Norketotifen (NKT) in the Treatment of Acute Uncomplicated Influenza-like Illness (ILI)

This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.

Study Overview

• Status: Completed
• Conditions: Influenza -Like Illness
• Intervention / Treatment: Drug: Placebo; Drug: Norketotifen

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Cahaba Research
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trial Services
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • Sacramento, California, United States, 95821
      • Northern California Research
  • Colorado
    • Denver, Colorado, United States, 80246
      • AFC Urgent Care
  • Florida
    • Miami, Florida, United States, 33135
      • South Florida Research Center
    • Miami, Florida, United States, 33165
      • Premier Research Associate
    • Tampa, Florida, United States, 33607
      • Gulfcoast Medical Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70124
      • DelRicht Research
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • The Clinical Research Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • OnSite Clinical Solutions
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Austin, Texas, United States, 78735
      • Premier Family Physicians
    • Carrollton, Texas, United States, 75010
      • Family Medicine Associates of Texas
    • Dallas, Texas, United States, 75204
      • CityDoc Urgent Care
    • Plano, Texas, United States, 75024
      • Village Health Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations

2. Symptoms of ILI including all of the following:

   • Fever ≥38º Celsius (oral) in the predose examinations or >4 hours after dosing of antipyretics if they were taken
   • At least one of the following general systemic symptoms associated with ILI are present with a severity of moderate or greater: headache, feverishness or chills, muscle or joint pain, fatigue
   • At least one of the following respiratory symptoms associated with ILI are present with a severity of moderate or greater: cough, sore throat, nasal congestion

3. The time interval between the onset of symptoms and the predose examinations is ≤96 hours. The onset of symptoms is defined as either:

   • Time of the first increase in body temperature (an increase of at least 1º Celsius from normal body temperature)
   • Time when the subject experiences at least one general or respiratory symptom
4. Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

Exclusion Criteria:

1. Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
2. Severe ILI requiring inpatient treatment

3. Any of the following risk factors (according to the CDC's list of People at High Risk for Developing Serious Flu-Related Complications):

   • Residents of nursing homes or other long-term care facilities
   • American Indians and Alaska natives
   • Asthma
   • Chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
   • Neurological and neurodevelopmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
   • Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
   • Blood disorders (such as sickle cell disease)
   • Endocrine disorders (such as diabetes mellitus)
   • Kidney disorders
   • Liver disorders
   • Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
   • Compromised immune system due to disease or medication (such as subjects with human immunodeficiency virus or cancer, or those on chronic steroids)
   • Extreme obesity (body mass index ≥40 kg/m^2)
4. Presence of any severe or uncontrolled medical or psychiatric illness
5. History of or current autoimmune disease
6. History of recurrent lower respiratory tract infection
7. Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
8. Female subjects who are pregnant or breastfeeding
9. Any clinically significant electrocardiogram test
10. Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
11. Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
12. Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
13. Exposure to an investigational drug within 30 days prior to the pre-dose examinations
14. History of allergic reaction to ketotifen
15. Any prior exposure to norketotifen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norketotifen; Norketotifen oral capsules, once daily for 5 days	Drug: Norketotifen; Oral capsule
Placebo Comparator: Placebo; Placebo oral capsules, once daily for 5 days	Drug: Placebo; Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to alleviation of symptoms	Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects whose symptoms have been alleviated at each time point through Day 5	5 days
Change from baseline in composite symptom score at each time point through Day 5	5 days
Time to resolution of fever (body temperature equal to or less than 37ºC)	14 days
Body temperature at each time point through Day 5	5 days
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)	14 days
Time to resumption of normal activity	14 days
Use of rescue medication (acetaminophen)	14 days

Collaborators and Investigators

• Sponsor: Emergo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): April 5, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: NKT-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No