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Clinical Trials/NCT04043923
NCT04043923CompletedPhase 2

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)

Emergo Therapeutics, Inc.17 sites in 1 country238 target enrollmentStarted: October 21, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
238
Locations
17
Primary Endpoint
Time to alleviation of symptoms

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations
  • 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
  • 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
  • Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

Exclusion Criteria

  • Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
  • Severe ILI requiring inpatient treatment
  • 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
  • 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)
  • Presence of any severe or uncontrolled medical or psychiatric illness
  • History of or current autoimmune disease
  • History of recurrent lower respiratory tract infection
  • Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
  • Female subjects who are pregnant or breastfeeding
  • Any clinically significant electrocardiogram test
  • Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
  • Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
  • Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
  • Exposure to an investigational drug within 30 days prior to the pre-dose examinations
  • History of allergic reaction to ketotifen
  • Any prior exposure to norketotifen

Arms & Interventions

Norketotifen

Experimental

Norketotifen oral capsules, once daily for 5 days

Intervention: Norketotifen (Drug)

Placebo

Placebo Comparator

Placebo oral capsules, once daily for 5 days

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Time to alleviation of symptoms

Time Frame: 14 days

Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)

Secondary Outcomes

  • 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)
  • 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)
  • Body temperature at each time point through Day 5(5 days)
  • Use of rescue medication (acetaminophen)(14 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (17)

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