A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea

NCT03590366 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RB244-001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 9

Brief Summary

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.

Conditions

Rosacea

Keywords

Type 1 erythematotelangiectatic rosacea

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.

  Baseline to Day 84

Secondary Outcomes (6)

• Proportion of Subjects With IGA Improvement at Week 8 Relative to Baseline.

  Baseline to Day 56

• Proportion of Subjects With CEA Improvement at Week 8 Relative to Baseline.

  Baseline to Day 56

• Change in IGA From Week 8 to Baseline.

  Baseline to Day 56

• Change in CEA From Week 8 to Baseline.

  Baseline to Day 56

• Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline.

  Baseline to Day 84

Study Arms (2)

B244

ACTIVE COMPARATOR

B244 suspension in 30ml/bottle Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day.

Biological: B244

Vehicle

PLACEBO COMPARATOR

Vehicle, 30ml/bottle Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day.

Biological: Vehicle

Interventions

B244 BIOLOGICAL

B244 Suspension

B244

Vehicle BIOLOGICAL

Vehicle suspension

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ≥18.
• A clinical diagnosis of mild to moderate facial rosacea.
• In good general health as determined by a thorough medical history, physical examination, clinical chemistry and hematology.
• Presence of 3 to 20 inflammatory lesions on the face (i.e. papules/pustules).
• A Clinician Erythema Assessment (CEA) score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application).
• Mild to Moderate IGA score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application).
• Willing to refrain from using any topical or systemic treatments for the treatment of rosacea, other than the investigational product.
• Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline/Day 1 (prior to the investigational product application).
• Ability to comprehend and comply with study procedures.
• Agree to commit to participate in the current protocol.
• Provide written informed consent prior to any study procedure being performed.

You may not qualify if:

• Female subjects who are pregnant, lactating or who are trying to conceive will be excluded from participation in this study.
• Any uncontrolled chronic or serious disease or medical condition that would normally prevent participation in a clinical trial, or, in the judgment of the Investigator, would put the subject at undue risk, or might confound the study assessments (e.g., other dermatological diseases), or might interfere with the subject's participation in the study, (e.g., planned hospitalization during the study).
• Particular forms of rosacea (e.g., rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, Ocular rosacea Phymatous rosacea, Steroid-induced rosacea, severe rosacea including pyoderma faciale) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
• Presence of more than two (2) nodulocystic lesions on the face.
• Presence of less than 3 and more than 20 inflammatory lesions on the face (i.e. papules/pustules).
• Severe papulopustular rosacea requiring systemic treatment.
• Participation at the time of eligibility assessment (Screening) in any other investigational drug or device study or may have participated within 30 days prior to Screening.
• Commencement of new hormonal therapy or dose change to hormonal therapy within 30 days prior to baseline. Dose and frequency of use of any hormonal therapy started more than 30 days prior to baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (e.g. vaginal ring or transdermal hormone contraception)
• Presence of beard or excessive facial hair at Screening which would interfere with the study treatments or study assessments and refusal to remove for duration of study.
• Carcinoid, Pheochromocytoma or other systemic causes of flushing.
• Known sensitivity to B244 or its components.
• Refusal to submit to blood and urine sampling for laboratory analysis.
• Treatment with prohibited medications.

Sponsors & Collaborators

• AOBiome LLC: lead
• bioRASI, LLC: collaborator

Study Sites (9)

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Veritas Research Corp

Miami, Florida, 33126, United States

Location

South Coast Research Center, Inc.

Miami, Florida, 33136, United States

Location

FXM Research Corp.

Miami, Florida, 33175, United States

Location

FXM Research Miramar

Miramar, Florida, 33027, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Paddington Testing Co.

Philadelphia, Pennsylvania, 19103, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

West Houston Clinical Research Service

Houston, Texas, 77055, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

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

hkim@aobiome.com

617-639-9980

Study Officials

• Judith Ng-Cashin, MD

  Chief Medical Officer

  STUDY DIRECTOR

• Spiros Jamas, ScD

  AOBiome Therapeutics

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind study. Participants will be assigned to study treatment in accordance with the randomization schedule generated for the allocation of vehicle or B244 prior to the initiation of the trial. Randomization will be centrally-based and performed using an appropriate IWRS (an automated randomization system). Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 18, 2018
• Study Start: July 2, 2018
• Primary Completion: February 11, 2019
• Study Completion: March 5, 2019
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-08

Locations

US (9)