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 being studied for the treatment of perennial and seasonal allergic rhinitis, which are year-round and seasonal forms of nasal allergy. It is an investigational small molecule developed by GSK plc. The clinical work in this program has focused on intranasal use in adults with allergic rhinitis.
Levocabastine targets HRH1, the histamine H1 receptor, and acts as an antagonist at that receptor. By blocking HRH1, it interferes with histamine-driven signaling that contributes to allergic nasal symptoms. This makes it a small molecule antihistamine approach for allergic rhinitis.
Levocabastine is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical study of intranasal levocabastine in allergic rhinitis. The compound is a small molecule in the respiratory therapeutic area.
Levocabastine is in Phase 2 clinical development for perennial and seasonal allergic rhinitis. It is investigational and has not been approved for this use. The Phase 2 study in the program has been completed, and no trials are currently listed as active.
Levocabastine has been studied in one completed Phase 2 trial, NCT01949051, titled A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis. That randomized, double-blind study enrolled 78 adults in Canada with perennial and seasonal allergic rhinitis.