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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04610047




Registration number
NCT04610047
Ethics application status
Date submitted
26/10/2020
Date registered
30/10/2020
Date last updated
30/01/2023

Titles & IDs
Public title
Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness
Scientific 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)
Secondary ID [1] 0 0
NKT-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Influenza -Like Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Norketotifen
Treatment: Drugs - Placebo

Experimental: Norketotifen - Norketotifen oral capsules, twice daily for 7 days

Placebo Comparator: Placebo - Placebo oral capsules, twice daily for 7 days


Treatment: Drugs: Norketotifen
Oral capsule

Treatment: Drugs: Placebo
Oral capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to alleviation of symptoms
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Time to resolution of fever (body temperature equal to or less than 37ºC)
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Proportion of subjects whose symptoms have been alleviated at each time point through Day 14
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Change from baseline in composite symptom score at each time point through Day 14
Timepoint [3] 0 0
14 days
Secondary outcome [4] 0 0
Body temperature at each time point through Day 14
Timepoint [4] 0 0
14 days
Secondary outcome [5] 0 0
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
Timepoint [5] 0 0
14 days
Secondary outcome [6] 0 0
Time to resumption of normal activity
Timepoint [6] 0 0
14 days
Secondary outcome [7] 0 0
Use of rescue medication (acetaminophen)
Timepoint [7] 0 0
14 days
Secondary outcome [8] 0 0
Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)
Timepoint [8] 0 0
14 days
Secondary outcome [9] 0 0
Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza)
Timepoint [9] 0 0
14 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/02/2022
Sample size
Target
Accrual to date
Final
315
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
South Dakota
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
West Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Emergo Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04610047
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04610047