Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis

NCT03290248 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ARB244-001
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal allergic rhinitis.

Conditions

Allergic Rhinitis; Allergic Rhinitis Due to Grass Pollen; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study.

  Baseline to Day 28

Secondary Outcomes (10)

• Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment

  Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

• Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment

  Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

• Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment

  Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

• Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment

  Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

• Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment

  Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Other Outcomes (4)

• Change in Peak Nasal Inspiratory Flow (PNIF)

  Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

• Nasal Inflammation Score Using Otoscope

  Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

• Intranasal Nitric Oxide Levels

  Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Study Arms (3)

Vehicle

PLACEBO COMPARATOR

Intranasal application: 1 pump (140ul) per nostril BID for 14 days

Biological: Vehicle

B 244 1x (low dose)

ACTIVE COMPARATOR

Intranasal application: 1 pump (140ul) per nostril BID for 14 days

Biological: B244 suspension

B244 4x (mid dose)

ACTIVE COMPARATOR

Intranasal application: 1 pump (140ul) per nostril BID for 14 days

Biological: B244 suspension

Interventions

B244 suspension BIOLOGICAL

B244 suspension in 30ml/bottle

B 244 1x (low dose); B244 4x (mid dose)

Vehicle BIOLOGICAL

Vehicle, 30ml/bottle

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females, 18 to 65 years of age (committed to consistent use of an acceptable method of birth control as described in Section 10).
• In good general health as determined by a thorough medical history and physical examination, and vital signs.
• Nonsmoker or ex-smoker (stopped \>1 year prior to study entry).
• Subjects willing and able to provide written informed consent.
• Is willing and able to comply with the requirements of the protocol and must be available for the full duration of the study.
• For Part 1, subjects asymptomatic from any seasonal or perennial allergens.
• For Part 1, elevated systolic blood pressure greater than 120 but less than 160 and never been on antihypertensive medications or have been off any hypertensive treatment for a period of 12 weeks or longer.
• For Part 2, subjects with a well-documented history of seasonal allergic rhinitis (specifically ragweed pollen) with documentation of sensitivity by positive skin testing and/or IgE testing to the relevant allergens 12 months prior to enrollment that correlate with clinical history.
• For Part 2, a ragweed positive skin prick test with a wheal diameter at least 5 mm larger than the negative control and/or a ragweed specific IgE greater or equal to 0.7 kU/L.
• For Part 2, subjects with confounding allergies, or sensitization to cat epithelia, dog epithelia, Dermatophagoides farinae, or Dermatophagoides pteronyssinus or prevalent and relevant seasonal allergens as per the skin prick test may be included if sensitization is not clinically relevant (ie. subject is non-symptomatic and/or can avoid the allergen during the study) at the discretion of the Investigator.
• For Part 2, subjects with a baseline TNSS ≤ 3/12 at Visit 3 and a minimum qualifying TNSS score of a change of 6/12 from their baseline score after NAC #1 on at least 2 diary cards.
• For Part 2, subjects' average post diluents nasal congestion score must be \< 1 at admission for each study visit.

You may not qualify if:

• Pregnancy or breast-feeding
• Female of childbearing potential not using adequate contraceptive measures.
• Smoking within the past year or during the protocol.
• Systemic corticosteroid or other immunosuppressive medications use in the previous three months or during the protocol.\*
• Intranasal corticosteroid use in the previous month or during the protocol.\*
• Intranasal antihistamine or cromolyn use in the previous week or during the study.\*
• Allergen immunotherapy during previous 12 months or during the protocol.\*
• Omalizumab use in previous 12 months or during the protocol.\*
• Systemic antihistamine or leukotriene modifying medication use in the previous week or during the protocol.\*
• Use of antibiotics, NSAIDS, antihypertensives, beta-blockers, photosensitizing medications, or vitamin D supplements during study.
• Use of any intranasally administered over-the-counter product or nasal irrigation (e.g., neti pot) during study.
• Inability to give informed consent.
• Persistent asthma or any medical condition that in the opinion of the investigator may compromise the subject's ability to safely participate in the study.
• Subjects with any significant clinical abnormalities which may interfere with study participation.
• Prior use of AO+ Mist.

Sponsors & Collaborators

• AOBiome LLC: lead
• Orange County Research Center: collaborator
• Integrium: collaborator

Study Sites (2)

Orange County Research Center

Tustin, California, 92780, United States

Location

Inflamax

Mississauga, Ontario, M6G 3V1, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Hyun Kim, Vice President Clinical Operations
• Organization: AOBiome Therapeutics

hkim@aobiome.com

617-639-9980

Study Officials

• Joel Neutel, MD

  Study PI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 21, 2017
• Study Start: September 19, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: November 25, 2022
• Results First Posted: November 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)