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

Conditions:Psoriasis, Skin and Soft Tissue Infections, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:2 - 17
Start Date:December 7, 2018
End Date:July 2019
Contact:Robert Calhoun

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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

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

This is a Phase 1b, open-label, single arm, multiple site study assessing twice daily B244
application for 28 days in pediatric subjects with mild to moderate atopic dermatitis.

Number of Subjects:

The study will enroll 36 subjects in 3 cohorts of 12 subjects:

- Cohort 1: subjects aged 2 to 5 years.

- Cohort 2: subjects aged 6 to 11 years.

- Cohort 3, subjects aged 12 to 17 years.

At Screening and Baseline, all subjects must have confirmed diagnosis of atopic dermatitis,
as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% but no more
than 60% body surface area and a Validated Investigator Global Assessment for Atopic
Dermatitis (vIGA-AD) scale of 2 or 3.

The duration of the study will be approximately 7 weeks. Subjects will attend for a Screening
visit between Days -21 and -14. If all eligibility criteria and none of the exclusion
criteria are met, subjects will be enrolled into the study and will be required to undergo a
14 day washout period (Days-14 to -1). Subjects will attend the study center on Day 1 and the
Baseline assessments will be performed before application of the first dose.

On confirmation of continued eligibility the subject and parent or guardian of the subject
will be coached on how to apply medication, depending on the affected areas. They will be
instructed to apply B244 twice daily (approximately 12 hours apart) for 28 days.

The first dose will be applied in the clinic under the supervision of clinical staff. Details
of dose administration will be recorded in the study diary provided. The subjects with their
parent or guardian will return to the study center on Days 7, 14, and 21 for completion of
study assessments.

There will be a final study visit on Day 28, this will be defined as the end of the study for
the subjects. A time window of ±2 day will be permitted for these 4 visits. There will not be
a period of confinement in the study center all visits will be outpatient visits. Safety
monitoring will include review of TEAEs, vital signs and physical examination. Efficacy will
be assessed using EASI, vIGA-AD scale, POEM and ItchMan scores.

Inclusion Criteria:

- Subjects are eligible to be included in the study only if all of the following
criteria apply:

1. Male and female subjects 2 to 17 years of age, inclusive.

2. Confirmed diagnosis of atopic dermatitis according to the Hanifin and Rajka

3. 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).

4. A vIGA-AD scale of 2 or 3 at Screening and Baseline.

5. Subject, or the parent or guardian, to provide written informed consent and
authorization for protected health information disclosure.

6. Subjects must be generally in good health based on Investigator's assessment
(other than atopic dermatitis).

7. 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.

8. 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.

9. 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).

10. Ability to comprehend and comply with study procedures.

11. Agree to commit to participate in the current protocol.

12. Provide written informed consent prior to any study procedure being performed.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

1. 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.

2. Subjects with atopic dermatitis on the face only.

3. Active cutaneous bacterial, viral or fungal infection in any treatment area at
Baseline (eg, clinically infected atopic dermatitis).

4. 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.

5. Unstable atopic dermatitis or a consistent requirement for high-potency
corticosteroids (class I-III steroids).

6. Active systemic or localized infection (including infected AD).

7. Subjects unable to comply with the excluded medication/therapy restriction

8. Known hypersensitivity to the study treatment.

9. 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

10. Female subject who is pregnant, breastfeeding, or considering pregnancy during
the study.

11. Any skin condition which in the Investigator's opinion may interfere with the
evaluation of atopic dermatitis.

12. 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.

13. Use of any biologic within a period of 5 times its half-life.

14. Children or relatives of the Sponsor, clinical research organization, or the
Study Site personnel are excluded from participating in the study.
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