Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis

Phase 2

Completed

Conditions: Allergic Rhinitis
Allergic Rhinoconjunctivitis

Interventions: Drug: Placebo
Drug: Norketotifen

Registration Number: NCT03887026

Lead Sponsor: Emergo Therapeutics, Inc.

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo single dose
NKT High Dose	Norketotifen	NKT single dose - High
NKT Low Dose	Norketotifen	NKT single dose - Low

Primary Outcome Measures

Name	Time	Method
Change in Total Nasal Symptom Score (TNSS) from pre-dose to 6 hours post-dose	6 hours	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.

Secondary Outcome Measures

Name	Time	Method
Change in Total Ocular Symptom Score (TOSS) from pre-dose to 6 hours post-dose	6 hours	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.
Change in individual nasal symptoms from pre-dose to 6 hours post-dose	6 hours	Change in individual nasal symptoms from pre-dose to 6 hours post-dose for NKT vs placebo
Change in individual ocular symptoms from pre-dose to 6 hours post-dose	6 hours	Change in individual ocular symptoms from pre-dose to 6 hours post-dose for NKT vs placebo
AUC of TSS over 6 hours post-dose	6 hours	AUC of TSS over 6 hours post-dose for NKT vs placebo
Change in Total Symptom Score (TSS) from pre-dose to 6 hours post-dose	6 hours	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.
Area under the curve (AUC) of TNSS over 6 hours post-dose	6 hours	AUC of TNSS over 6 hours post-dose for NKT vs placebo
AUC of TOSS over 6 hours post-dose	6 hours	AUC of TOSS over 6 hours post-dose for NKT vs placebo