Efficacy and Safety of Norketotifen in 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; Influenza -Like Illness
• Intervention / Treatment: Drug: Placebo; Drug: Norketotifen

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ
  • California
    • Los Angeles, California, United States, 90017
      • Downtown LA Research Center
  • Florida
    • DeBary, Florida, United States, 32713
      • Omega Research DeBary
    • Kissimmee, Florida, United States, 34744
      • The Chappel Group Research
    • Miami, Florida, United States, 33135
      • South Florida Research Center
    • Miami, Florida, United States, 33165
      • Premier Research Associate
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida
  • Louisiana
    • Eunice, Louisiana, United States, 70535
      • Horizon Research Group of Opelousas
  • Maryland
    • Towson, Maryland, United States, 21204
      • Continental Clinical Solutions
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Clinical Research of South Nevada
  • North Carolina
    • Louisburg, North Carolina, United States, 27549
      • Relief Integrated Health Care
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
  • Pennsylvania
    • Scottdale, Pennsylvania, United States, 15683
      • Frontier Clinical Research
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Clinovacare Medical Research Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Clinical Research Solutions
  • Texas
    • Dallas, Texas, United States, 75251
      • Cedar Health Research
    • Houston, Texas, United States, 77027
      • Advanced Medical Group
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Frontier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 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)
   • 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. Total symptom severity score (sum of the scores of all 7 individual symptoms) of ≥11 in the predose examinations
4. The time interval between the onset of symptoms and the predose examinations is ≤48 hours.
5. Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

Exclusion Criteria:

1. Known or suspected infection with Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) or Coronavirus Disease 2019 (COVID-19) illness
2. Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
3. Severe ILI requiring inpatient treatment

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

   • Extreme obesity (body mass index ≥40 kg/m^2)
   • 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)
5. Presence of any severe or uncontrolled medical or psychiatric illness
6. History of or current autoimmune disease
7. History of recurrent lower respiratory tract infection
8. Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
9. Any clinically significant electrocardiogram (ECG) test
10. Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the predose examinations
11. Received an investigational monoclonal antibody for a viral disease in the last year prior to the predose examinations
12. Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the predose examinations
13. Exposure to an investigational drug within 30 days prior to the predose 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: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norketotifen; Norketotifen oral capsules, twice daily for 7 days	Drug: Norketotifen; Oral capsule
Placebo Comparator: Placebo; Placebo oral capsules, twice daily for 7 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
Time to resolution of fever (body temperature equal to or less than 37ºC)	14 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
Proportion of subjects whose symptoms have been alleviated at each time point through Day 14	14 days
Change from baseline in composite symptom score at each time point through Day 14	14 days
Body temperature at each time point through Day 14	14 days
Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)	14 days
Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza)	14 days

Collaborators and Investigators

• Sponsor: Emergo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

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-203

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