Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001455853
Ethics application status
Approved
Date submitted
13/09/2021
Date registered
25/10/2021
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of REVTx-99 on alleviating or preventing allergy symptoms
Scientific title
Investigating the safety of REVTx-99 in Participants With Allergic Rhinitis to Rye Grass Pollen
Secondary ID [1] 305280 0
RVL-CLR01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 323579 0
Condition category
Condition code
Inflammatory and Immune System 321127 321127 0 0
Allergies
Respiratory 321128 321128 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321684 0
Prevention
Intervention code [2] 321685 0
Treatment: Drugs
Comparator / control treatment
Placebo (5% ethanol in sterile water) will be used as the control group.
Control group
Placebo

Outcomes
Primary outcome [1] 328905 0
Occurence of treatment emergent adverse events gathered through physical exam, non-leading questioning and telephone follow-up.
Timepoint [1] 328905 0
At each point of contact from the start of REVTx-99 administration through to End of Study (Day 19 post- first REVTx-99/placebo administration for Part A, Day 17 post- first REVTx-99/placebo administration for Part B)
Primary outcome [2] 328906 0
Safety and tolerability of REVTx-99 assessed through changes in clinical labororatory evaluations (Haematology, Clinical Chemistry and Urinalysis), vital signs, 12-lead ECG and physical examinations
Timepoint [2] 328906 0
At each point of contact from the start of study drug administration through to End of Study (Day 19 post- first REVTx-99/placebo administration for Part A, Day 17 post- first REVTx-99/placebo administration for Part B)
Primary outcome [3] 328907 0
Use of rescue treatment, assessed via recording of concomitant medications
Timepoint [3] 328907 0
At every point of contact from signing of consent through to End of Study (Day 19 post-REVTx-99/placebo administration for Part A, Day 17 post-REVTx-99/placebo administration for Part B)
Secondary outcome [1] 400834 0
Composite outcome:
The effect of REVTx-99 on the Total Nasal Symptom Score (TNSS) before and after study drug administration.
Assessed using the baseline corrected Area Under the Curve (AUC) of TNSS after the rye grass challenge, the duration of nasal symptoms and the peak TNSS after the Nasal Allergen Challenge (NAC).
Timepoint [1] 400834 0
Part A: TNSS is measured on multiple occasions during screening, on day 1, day 2, day 3, day 4, day 10, day 11, day 12 and day 13 post- first REVTx-99/placebo administration.
Part B: TNSS is measured on multiple occasions during screening, on day 1, day 2, day 3, day 9, day 10 and day 11 post- first REVTx-99/placebo administration.
Secondary outcome [2] 400835 0
The effect of REVTx-99 on nasal symptoms measured by peak nasal inspiratory flow (PNIF).
Assessed by the Baseline corrected AUC of PNIF after the rye grass challenge.
Timepoint [2] 400835 0
Part A: PNIF is measured on multiple occasions during screening, on day 1, day 2, day 3, day 10, day 11 and day 12 post- first REVTx-99/placebo administration.
Part B: PNIF is measured on multiple occasions during screening, on day 1, day 2, day 9 and day 10 post- first REVTx-99/placebo administration.
Secondary outcome [3] 400837 0
The pharmacokinetics of the REVTx-99 by measurement of:
- Maximum peak observed concentration (Cmax)
- Time to maximum concentration (tmax)
- Area under the concentration-time curve from Hour 0 through the last quantifiable concentration time (AUC last)
- Area under the serum concentration-time curve extrapolated to infinity (AUC infinity)
- Apparent terminal elimination rate constant (kel)
- Apparent terminal half-life (t1/2)
- Apparent total clearance (CL/F)
- Apparent volume of distribution (Vz/F)
Timepoint [3] 400837 0
Part A: Samples collected on multiple occasions on Day 1, Day 2, Day 3, Day 10, Day 11 and Day 12 post- first REVTx-99/placebo administration.
Part B: Samples collected on multiple occasions on Day 1, Day 2, Day 9 and Day 10 post- first REVTx-99/placebo administration.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/11/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
16/03/2022
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20508 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 35285 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 309654 0
Commercial sector/Industry
Name [1] 309654 0
Revelation Biosciences
Country [1] 309654 0
United States of America
Primary sponsor type
Other
Name
Linear Clinical Research Ltd
Address
Level 1, B Block
Hospital Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 310668 0
Commercial sector/Industry
Name [1] 310668 0
Revelation Biosciences
Address [1] 310668 0
Revelation Biosciences, Inc.
4660 La Jolla Village Drive, Suite 100
San Diego, CA 92122
Country [1] 310668 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309421 0
Bellberry Limited
Ethics committee address [1] 309421 0
123 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 309421 0
Australia
Date submitted for ethics approval [1] 309421 0
25/08/2021
Approval date [1] 309421 0
14/10/2021
Ethics approval number [1] 309421 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114102 0
Dr Michaela Lucas
Address 114102 0
Linear Clinical Research
Level 1, B Block
Hospital Ave
Nedlands, WA 6009
Country 114102 0
Australia
Phone 114102 0
+61 466 553 256
Fax 114102 0
Email 114102 0
[email protected]
Contact person for public queries
Name 114103 0
Ms Carol Odle
Address 114103 0
Revelation Biosciences, Inc.
4660 La Jolla Village Drive, Suite 100
San Diego, CA 92122
Country 114103 0
United States of America
Phone 114103 0
+1 760 703 2438
Fax 114103 0
Email 114103 0
[email protected]
Contact person for scientific queries
Name 114104 0
Dr Shannan Lynch
Address 114104 0
Revelation Biosciences, Inc.
4660 La Jolla Village Drive, Suite 100
San Diego, CA 92122
Country 114104 0
United States of America
Phone 114104 0
+1 858 922 6110
Fax 114104 0
Email 114104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.