Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis

Efficacy and Safety of Single Doses of Norketotifen in Adult Subjects With Allergen-Induced Allergic Rhinitis in an Allergen Challenge Chamber

This is a Phase 2a study to evaluate the efficacy and safety of Norketotifen (NKT) in subjects with allergic rhinitis.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Allergic Rhinoconjunctivitis
• Intervention / Treatment: Drug: Placebo; Drug: Norketotifen

Detailed Description

This is a single-center, double-blind, randomized, placebo-controlled, 3-way crossover study evaluating the efficacy and safety of NKT in adult subjects with allergen-induced allergic rhinitis in an allergen challenge chamber.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Biogenics Research Chamber

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ability and willingness to provide informed consent and comply with the protocol procedures
• Males and females, age 18 to 45 years, inclusive
• Other than seasonal allergic rhinitis, participant is healthy as determined by pre-study medical history, physical examination and vital signs. Any chronic conditions that may interfere with the study outcomes or the subject's safety will be considered clinically significant and a reason for exclusion.
• History of seasonal allergic rhinitis to mountain cedar pollen for at least the past 2 consecutive seasons
• Positive mountain cedar pollen skin prick test at Screening or within 12 months prior to Screening (wheal diameter ≥5 mm larger than the negative control)
• For females, negative serum pregnancy test. Females of childbearing potential and males must agree to use required contraception as outlined in the protocol

Exclusion Criteria:

• Female subjects who are pregnant or lactating
• Any history of epilepsy, diabetes mellitus, blood pressure abnormalities or cardiac arrhythmias
• Presence of any uncontrolled medical or psychiatric illness
• Treatment for controlled concurrent medical conditions has not been stable in terms of either doses or medications for at least 30 days prior to the baseline visit or is anticipated to change during the study
• Current use of or expected use of any of the prohibited medications within the indicated withholding timeframes as outlined in the protocol
• History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study
• Any history of malignancy within the past 5 years, with the exception of non-melanoma skin cancer
• History of pulmonary disease and/or active asthma requiring daily drug therapy. Mild, intermittent asthma is permitted (managed with short acting beta-agonist less than 3 times per week). Isolated exercise-induced bronchospasm is also permitted
• Any infection or inflammatory condition within the 2 weeks prior to screening
• Positive human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) antibody screen
• Any clinically significant abnormal laboratory or ECG test. Presence of thrombocytopenia at screening is exclusionary
• Evidence of illicit drug use or positive urine Class A drug, alcohol, or cotinine screen
• Regular use of tobacco or nicotine containing products, including vaping, within 1 year prior to Screening
• Received any investigational drug within 30 days prior to Screening
• Any prior exposure to norketotifen
• History of allergic reaction to ketotifen
• In the opinion of the investigator, subject would be unlikely to comply with required study visits, self-assessments, and interventions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NKT Low Dose; NKT single dose - Low	Drug: Norketotifen; Norketotifen oral capsule
Experimental: NKT High Dose; NKT single dose - High	Drug: Norketotifen; Norketotifen oral capsule
Placebo Comparator: Placebo; Placebo single dose	Drug: Placebo; Placebo oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Nasal Symptom Score (TNSS) from pre-dose to 6 hours post-dose	Change in TNSS from pre-dose to 6 hours post-dose for NKT vs placebo. The TNSS is the sum of the scores of four nasal symptoms (runny nose, congestion, itching, and sneezing) each scored on a scale of 0 to 3 (0=absent; 1=mild; 2=moderate; 3=severe). The TNSS score ranges from 0 to 12.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Ocular Symptom Score (TOSS) from pre-dose to 6 hours post-dose	Change in TOSS from pre-dose to 6 hours post-dose for NKT vs placebo. The TOSS is the sum of the scores of three ocular symptoms (itching, tearing, and redness) each scored on a scale of 0 to 3 (0=absent; 1=mild; 2=moderate; 3=severe). The TOSS score ranges from 0 to 9.	6 hours
Change in Total Symptom Score (TSS) from pre-dose to 6 hours post-dose	Change in TSS from pre-dose to 6 hours post-dose for NKT vs placebo. The TSS is the sum of the TNSS and TOSS (described above) and ranges from 0 to 21.	6 hours
Area under the curve (AUC) of TNSS over 6 hours post-dose	AUC of TNSS over 6 hours post-dose for NKT vs placebo	6 hours
AUC of TOSS over 6 hours post-dose	AUC of TOSS over 6 hours post-dose for NKT vs placebo	6 hours
AUC of TSS over 6 hours post-dose	AUC of TSS over 6 hours post-dose for NKT vs placebo	6 hours
Change in individual nasal symptoms from pre-dose to 6 hours post-dose	Change in individual nasal symptoms from pre-dose to 6 hours post-dose for NKT vs placebo	6 hours
Change in individual ocular symptoms from pre-dose to 6 hours post-dose	Change in individual ocular symptoms from pre-dose to 6 hours post-dose for NKT vs placebo	6 hours

Collaborators and Investigators

• Sponsor: Emergo Therapeutics, Inc.
• Investigators: Study Chair: Hazar Awad Granko, RPh, PhD, Emergo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): May 18, 2019
• Study Completion (Actual): May 29, 2019

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: NKT-201

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