Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levocabastine · 1 trial · 1 indication
The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.
| Arm | Type | Description |
|---|---|---|
| Levocabastine Arm | EXPERIMENTAL | Subjects will be assigned to one of six treatment sequences (ABC, BCA, CAB, ACB, BAC, CBA) in accordance with the randomisation schedule. A = Two, 50 microgram (mcg) sprays per nostril of levocabastine QD in the morning. Total dose of 200 mcg. Two, 0 mcg sprays from placebo to match vehicle in the evening; B = Two, 50 mcg sprays per nostril of levocabastine BID in the morning and evening. Total dose of 400 mcg; C = Two, 0 mcg sprays per nostril from placebo vehicle in morning and evenings. |
| Name | Type | Description |
|---|---|---|
| Levocabastine | DRUG | Intranasal aqueous 50 mcg microsuspension of levocabastine supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension |
| Placebo | DRUG | Intranasal aqueous 0 mcg microsuspension supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension |
Inclusion Criteria: * Diagnosis of Allergic Rhinitis (AR), as determined by the presence of seasonal or perennial rhinitis symptoms for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities. * Subjects have a TNSS score of \>=6 at the baseline scr...
Levocabastine is an investigational small molecule being developed for the treatment of allergic rhinitis, including perennial and seasonal forms. It is administered intranasally and is currently in Phase 2 clinical development. The drug is not yet approved and remains under investigation for this respiratory condition.
Levocabastine is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with allergic rhinitis.
Levocabastine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of perennial and seasonal allergic rhinitis, with one completed Phase 2 trial supporting its continued development.
Levocabastine has one completed clinical trial, registered as NCT01949051. This Phase 2 study, titled 'A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis,' enrolled 78 participants in Canada. The trial was randomized and double-blind, though it did not use a control group.
Levocabastine is a small molecule designed for intranasal administration to treat allergic rhinitis. As a therapeutic agent in respiratory medicine, it is intended to alleviate symptoms associated with perennial and seasonal allergies, though its specific molecular target has not been disclosed in available information.