A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis

NCT03775434 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ADB244-002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

Brief Summary

An open-label, multicenter, Phase Ib study of B244 delivered as a topical spray to assess safety in pediatric subjects aged 2 to 17 years with atopic dermatitis Condition or disease Intervention/treatment Phase Atopic Dermatitis (Eczema) Biological: B244 Phase 1b

Conditions

Eczema; Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)as Assessed by CTCAE v4.0

  Safety and tolerability endpoints will consist of all adverse events reporting from Baseline to Day 28.

  Baseline to Day 28

• Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.

  A physical exam will be conducted by a physician assessing systems (General appearance, Dermatological, Musculoskeletal, Thyroid, HEENT \[Head, eyes, ears, nose, throat\], Lymphatic, Respiratory, Gastrointestinal, Cardiovascular, Neurological, Extremities, and other). Clinical significance of the physical exam will be determined at investigator's discretion. Results for each system were assessed as Normal, Abnormal CS (clinically significant), or Abnormal NCS (not clinically significant) and shift was analyzed from Baseline to Day 28.

  Baseline to Day 28

• Mean Change in Blood Pressure From Baseline at Day 28

  Blood pressure will be obtained (mmHg). Clinical significance of blood pressure will be determined at the investigator's discretion. Change from Day 28 to Baseline.

  Baseline to Day 28

• Mean Change in Pulse Rate From Baseline at Day 28

  Pulse rate (beats per minute \[bpm\]) will be obtained. Clinical significance of pulse rate will be determined at the investigator's discretion. Change from Day 28 to Baseline.

  Baseline to Day 28

• Mean Change in Body Temperature From Baseline at Day 28

  Body temperature (°C) will be obtained. Clinical significance of body temperature will be determined at the investigator's discretion. Change from Day 28 to Baseline.

  Baseline to Day 28

Other Outcomes (4)

• Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).

  Baseline, Days 7, 14, 21, and 28

• Changes in Area Severity Index (EASI) Score.

  Baseline, Days 7, 14, 21, and 28

• Changes in Patient Oriented Eczema Measure (POEM Total Score).

  Baseline, Days 7, 14, 21, and 28

Study Arms (1)

B244

EXPERIMENTAL

B244 suspension in 30ml/bottle

Drug: Experimental: B244

Interventions

Experimental: B244 DRUG

B244 suspension in 30ml/bottle

B244

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects are eligible to be included in the study only if all of the following criteria apply:
• Male and female subjects 2 to 17 years of age, inclusive.
• Confirmed diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria.
• A minimum of 10% but no more than 60% of the subjects' body surface area (see Appendix 6 for guidance) is affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, and excoriation; with the excoriation serving as the physical examination correlate of pruritus).
• A vIGA-AD scale of 2 or 3 at Screening and Baseline.
• Subject, or the parent or guardian, to provide written informed consent and authorization for protected health information disclosure.
• Subjects must be generally in good health based on Investigator's assessment (other than atopic dermatitis).
• Normal vital signs, or with no clinically significant vital signs that in the opinion of the Investigator, would place the subject at increased risk or would confound the objectives of the study.
• Females must not be pregnant, as confirmed by negative urine pregnancy testing. Female subjects aged ≥11 years old, or female patients \<11 years old who have started menstruating, will have urinary pregnancy test performed at Screening and prior to the first dose with negative results in order to participate in the study. Females must either practice abstinence from heterosexual contact or use one of the highly effective contraceptive options described in the Appendix 5.
• Male subjects of reproductive potential, must be willing to practice effective contraception during the study while receiving study treatment from Day 1 and for 7 days after the last study visit (Day 28).
• 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:

• Subjects are excluded from the study if any of the following criteria apply:
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• Clinically significant physical or mental disorder which, in the opinion of the Investigator, would place the subject at increased risk or would confound the objectives of the study.
• Subjects with atopic dermatitis on the face only.
• Active cutaneous bacterial, viral or fungal infection in any treatment area at Baseline (eg, clinically infected atopic dermatitis).
• History or presence of immunological deficiencies or diseases, organ transplant, human immunodeficiency virus (HIV), diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant renal disease severe hepatic disorders, or other severe uncontrolled conditions (eg, drug or alcohol abuse), that are significant and/or that may pose a health risk to the subject in the study or may have an impact on the study assessments.
• Unstable atopic dermatitis or a consistent requirement for high-potency corticosteroids (class I-III steroids).
• Active systemic or localized infection (including infected AD).
• Subjects unable to comply with the excluded medication/therapy restriction
• Known hypersensitivity to the study treatment.
• Known to have hepatitis B, hepatitis C or HIV I or II tests. Details will be recorded in medical history, a blood sample will not be collected for confirmation.
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the study.
• Any skin condition which in the Investigator's opinion may interfere with the evaluation of atopic dermatitis.
• Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than 5 times the drug's half-life, whichever is longer.
• Use of any biologic within a period of 5 times its half-life.

Sponsors & Collaborators

• AOBiome LLC: lead
• Novella Clinical: collaborator

Study Sites (6)

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

Location

L.A. Universal Research Center, Inc.

Los Angeles, California, 90057, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Virginia Clinical Research, INC

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 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

• 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 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single arm open label study. Subjects will be assigned to the study treatment arm. Each participant will be scheduled to receive investigational product (IP).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will receive active product

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 14, 2018
• Study Start: December 7, 2018
• Primary Completion: May 18, 2019
• Study Completion: June 10, 2019
• Last Updated: August 5, 2024
• Results First Posted: August 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)