Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: B244; Vehicle
Intervention description: B244 suspension; Vehicle suspension
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: 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.
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II
      trial, comparing the effect of twice daily B244 application for 28 days vs vehicle
      application on treatment of mild to moderate AD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ≥18 years of age

          -  In good general health as determined by a thorough medical history and physical
             examination, and vital signs

          -  Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of
             Hanifin and Rajka

          -  Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21

          -  A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus

          -  A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic
             dermatitis (affected is defined by physical examination findings: erythema, edema,
             scaling, lichenification, excoriation, with the excoriation serving as the physical
             examination correlate of pruritus)

          -  An IGA score of 2-3

          -  Patient has a history of AD for ≥12 months

          -  Ability to read and understand English and to provide written informed consent and
             authorization for protected health information disclosure

        Exclusion Criteria:

          -  Pregnant and lactating women by urine pregnancy testing

          -  Subjects with any significant clinical abnormalities which may interfere with study
             participation

          -  Any skin condition which may interfere with evaluation of AD

          -  Atopic dermatitis only on the head or scalp

          -  Subjects with Atopic dermatitis on the face

          -  Unstable or actively infected atopic dermatitis

          -  Patients suffering from pruritus from conditions other than AD

          -  Patients with chronic pruritus due to systemic disease

          -  Patients with conditions requiring inhaled steroids

          -  Have concurrent skin disease of such severity in the study area that it could
             interfere with the study evaluation

          -  Have active skin infections on the treatment area

          -  Have received or planning to receive topical corticosteroids, topical coal tar,
             topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics
             or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy,
             oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics,
             glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents,
             systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within
             2 weeks of Baseline visit.

          -  Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex®
             and Trexall™ or its generic versions such as Methotrexate

          -  History of being seropositive for human immunodeficiency virus (HIV) at screening by
             laboratory testing at Screening

          -  History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive
             Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening

          -  History of renal disease

          -  Use of any investigational drugs within the previous 30 days prior to dosing or within
             a period of less than five times the drug's half-life, whichever is longer

          -  Use of any biologic within a period of 5 times its half-life

          -  Use of vinegar or bleach baths within 2 weeks of starting the study