Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

• ClinicalTrials.gov Identifier: NCT04610047
• Recruitment Status: Completed
• First Posted: October 30, 2020
• Last Update Posted: January 30, 2023
• Sponsor: Emergo Therapeutics, Inc.
• Information provided by (Responsible Party): Emergo Therapeutics, Inc.

Tracking Information

• First Submitted Date: October 26, 2020
• First Posted Date: October 30, 2020
• Last Update Posted Date: January 30, 2023
• Actual Study Start Date: December 14, 2020
• Actual Primary Completion Date: January 25, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2020)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 26, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness
• Official Title: 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Influenza
• Influenza -Like Illness

Intervention

• Drug: Norketotifen
  Oral capsule
• Drug: Placebo
  Oral capsule

Study Arms

• Experimental: Norketotifen
  Norketotifen oral capsules, twice daily for 7 days
  Intervention: Drug: Norketotifen
• Placebo Comparator: Placebo
  Placebo oral capsules, twice daily for 7 days
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2022): 315
• Original Estimated Enrollment (submitted: October 26, 2020): 320
• Actual Study Completion Date: February 9, 2022
• Actual Primary Completion Date: January 25, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Australia, New Zealand

Administrative Information

• NCT Number: NCT04610047
• Other Study ID Numbers: NKT-203
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Emergo Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Emergo Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Emergo Therapeutics, Inc.
• Verification Date: January 2023