Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis

NCT03887026 | Completed Phase 2 FDA Drug

• 1 other identifier: NKT-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Total Ocular Symptom Score (TOSS) from pre-dose to 6 hours post-dose

  6 hours

• Change in Total Symptom Score (TSS) from pre-dose to 6 hours post-dose

  6 hours

• Area under the curve (AUC) of TNSS over 6 hours post-dose

  6 hours

• AUC of TOSS over 6 hours post-dose

  6 hours

• AUC of TSS over 6 hours post-dose

  6 hours

Study Arms (3)

NKT Low Dose

EXPERIMENTAL

NKT single dose - Low

Drug: Norketotifen

NKT High Dose

EXPERIMENTAL

NKT single dose - High

Drug: Norketotifen

Placebo

PLACEBO COMPARATOR

Placebo single dose

Drug: Placebo

Interventions

Norketotifen DRUG

Norketotifen oral capsule

NKT High Dose; NKT Low Dose

Placebo DRUG

Placebo oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability and willingness to provide informed consent and comply with the protocol procedures
• Males and females, age 18 to 45 years, inclusive
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Emergo Therapeutics, Inc.: lead

Study Sites (1)

Biogenics Research Chamber

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

norketotifen

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hazar Awad Granko, RPh, PhD

  Emergo Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 22, 2019
• Study Start: April 1, 2019
• Primary Completion: May 18, 2019
• Study Completion: May 29, 2019
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)