None listed
Conditions
Brief summary
This is a study to evaluate the safety, tolerability, and effectiveness of intranasal REVTx-99 in adult volunteers with a history of allergic rhinitis to rye grass pollen. The study has 2 parts (Part A and Part B), in which each participant will be enrolled in only 1 part, and within each part there are 2 treatment periods (Period 1 and Period 2) that each participant will complete in a crossover manner. Part A will assess the effectiveness of REVTx-99 as a preventative for allergy symptoms and Part B will assess the effectiveness of REVTx-99 for treatment of allergy symptoms. Participants will receive both REVTx-99 and Placebo in both parts.
Interventions
25 micrograms REVTx-99 or placebo will be administered into each nostril before (Part A) or after (Part B) challenge with rye grass extract to induce an allergic reaction. Participants will receive both REVTx-99 and placebo, administered approximately 1 week apart.
The rye grass extract will be titrated to an effective concentration to elicit a substantial immune response, this titration will occur at the second screening visit and may include up to 4 different challenges. During the study part
25 micrograms REVTx-99 or placebo will be administered into each nostril before (Part A) or after (Part B) challenge with rye grass extract to induce an allergic reaction. Participants will receive both REVTx-99 and placebo, administered approximately 1 week apart. The rye grass extract will be titrated to an effective concentration to elicit a substantial immune response, this titration will occur at the second screening visit and may include up to 4 different challenges. During the study participants will be challenged a further 2 times. Treatment will be administered by trained site personnel who will ensure adherence.
Sponsors
Linear Clinical Research Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
- Adult volunteers, 18 to 55 years of age, inclusive, at Screening with a presumed history of allergic rhinitis to rye grass pollen. - Positive skin test to rye grass pollen at Screening, as defined as a wheal more than or equal to 3 mm. - Positive response to Screening NAC, as defined by an absolute TNSS of more than or equal to 8 points or a PNIF reduction of more than or equal to 50% from baseline. • Forced expiratory volume in 1 second (FEV1) more than 80% predicted and FEV1/ forced vital capacity (FVC) more than 70% predicted at Screening.
Exclusion criteria
- Positive hypersensitivity to the negative control used in the skin prick (less than 3 mm) or nasal diluent challenge (TNSS more than 2-point change from baseline) procedure at Screening. - Stable use of glucocorticoids or immunotherapy within 3 months prior to the first Screening visit and/or expected to require these treatments any time during the study. Stable use is defined as a frequency that is at least compliant to prescribed chronic therapy per the drug label or physician’s prescription. - Any use (i.e., 1 or more times) of glucocorticoids, mast cell stabilizers, immunotherapy, or nasal antibiotics within 28 days prior to the first Screening visit. - Use of systemic antibiotics or antivirals within 14 days prior to the first Screening visit (excluding non-intranasal topical/external use of antibiotics). - Topical or systemic antihistamines; decongestant preparations, mucolytics/secretolytics, or alternative medicine preparations for treatment of common cold-like symptoms; or any other intranasal medication or nasal irrigation, non-steroidal nasal topical treatment, or any intervention that could affect nasal symptoms within 7 days prior to the first Screening visit.
Outcome results
None listed