Allergic RhinitisPhase 2NCT03887026
Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis
A Phase 2 study testing Norketotifen in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by Emergo Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 2a study to evaluate the efficacy and safety of Norketotifen (NKT) in subjects with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- Norketotifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 29 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Biogenics Research Chamber
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- Norketotifen, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorketotifenDrug
Norketotifen oral capsule
PlaceboDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| NKT Low Dose | Experimental | NKT single dose - Low Receives: Drug: Norketotifen |
| NKT High Dose | Experimental | NKT single dose - High Receives: Drug: Norketotifen |
| Placebo | Placebo comparator | Placebo single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: 6 hours
AUC of TOSS over 6 hours post-dose
AUC of TOSS over 6 hours post-dose for NKT vs placebo
Measured: 6 hours
AUC of TSS over 6 hours post-dose
AUC of TSS over 6 hours post-dose for NKT vs placebo
Measured: 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
Measured: 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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Apr 2019
- Primary completion18 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hazar Awad Granko, RPh, PhD, Study chair, Emergo Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887026
- Sponsor's protocol ID
- NKT-201
- Status last verified
- Aug 2020
- First submitted
- 21 Mar 2019
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Single Doses of Norketotifen in Adult Subjects With Allergen-Induced Allergic Rhinitis in an Allergen Challenge Chamber
- ClinicalTrials.gov ID
- NCT03887026
- Acronym / sponsor ID
- NKT-201
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Emergo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 18 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NKT Low Dose | Experimental | Drug: NorketotifenNKT single dose - Low |
| NKT High Dose | Experimental | Drug: NorketotifenNKT single dose - High |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorketotifenNorketotifen oral capsule | Drug | NKT High Dose, NKT Low Dose |
| PlaceboPlacebo oral capsule | Drug | Placebo |
Primary outcome
Change in Total Nasal Symptom Score (TNSS) from pre-dose to 6 hours post-dose
Time frame: 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.
7 secondary outcomes
Change in Total Ocular Symptom Score (TOSS) from pre-dose to 6 hours post-dose
Time frame: 6 hours
Change in Total Symptom Score (TSS) from pre-dose to 6 hours post-dose
Time frame: 6 hours
Area under the curve (AUC) of TNSS over 6 hours post-dose
Time frame: 6 hours
AUC of TOSS over 6 hours post-dose
Time frame: 6 hours
AUC of TSS over 6 hours post-dose
Time frame: 6 hours
Change in individual nasal symptoms from pre-dose to 6 hours post-dose
Time frame: 6 hours
Change in individual ocular symptoms from pre-dose to 6 hours post-dose
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazar Awad Granko, RPh, PhD study chair
Emergo Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Norketotifen in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by Emergo Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Nasal Symptom Score (TNSS) from pre-dose to 6 hours post-dose (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.