CompletedPhase 1ACTRN12621001455853

Effect of REVTx-99 on alleviating or preventing allergy symptoms

Investigating the safety of REVTx-99 in Participants With Allergic Rhinitis to Rye Grass Pollen

Sponsor

Linear Clinical Research Ltd

Enrollment

28 participants

Start Date

Dec 8, 2021

Study Type

Interventional

Conditions

Allergic Rhinitis

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria4

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 Criteria5

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.

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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 participants will be challenged a further 2 times. Treatment will be administered by trained site personnel who will ensure adherence.