Overview

Tolerability and Effectiveness of CGB-500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis

Status:
Not yet recruiting
Trial end date:
2023-04-14
Target enrollment:
0
Participant gender:
All
Summary
The objective of the proposed study is to evaluate the tolerability and effectiveness of a 1% topical ointment of tofacitinib for the treatment of mild to moderate atopic dermatitis in adults. Adult patients with a diagnosis of atopic dermatitis for at least 6 months will be treated with the test product or placebo for a period of 8 weeks with a follow-up visit at 12 weeks. The primary endpoints are safety and tolerability of CGB-500 Ointment and a comparison of effectiveness of CGB-500 Ointment and Vehicle Ointments in treating lesion(s) of mild to moderate atopic dermatitis.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CAGE Bio Inc.
Treatments:
Tofacitinib
Criteria
Inclusion Criteria:

1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of
childbearing potential must have a negative urine pregnancy test at Baseline and
practice a reliable method of contraception throughout the study.

2. Have a clinical diagnosis of atopic dermatitis for at least 6 months prior to Day 0
(at the Screening and Baseline visit) that has been clinically stable for ≥3 months
prior to dose administration and is confirmed to be atopic dermatitis according to the
criteria of Hanifin and Rajka.

3. Have an IGA score of 2 (mild) or 3 (moderate) at Day 0.

4. Have an EASI score of 1.1 to 12.0 (i.e., mild or moderate).

5. Have atopic dermatitis on the arms and other body parts covering at least 2% of total
BSA and up to and including 12% of total Body Surface Area (BSA) at Day 0.

6. Have a presence of 1 to 3 target atopic dermatitis lesions of total surface area of 15
to 30 cm2, located on the body part visible to the subject. This is the target
lesion(s) that will be treated in this study.

7. Agree to use only low potency corticosteroid (up to 1% hydrocortisone) topical cream
or ointment for the other affected parts of the body that are not being treated with
the investigational product in the study, and at least 5 cm away from the treated
area.

8. In general, good health as determined by medical history and physical examination at
the time of screening (Investigator discretion).

9. Have a Peak Pruritus NRS score of ≥30 on the of scale 0 to 100, especially on the
target lesions.

10. Ability to follow study instructions and likely to complete all required visits.

11. Have signed the Institutional Review Board (IRB)-approved Informed Consent Form (ICF)
prior to any study-related procedures being performed.

12. Participating in any other clinical trial from 30 days prior to Screening and
throughout the planned 12-week study period.

Exclusion Criteria:

1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not
practicing reliable birth control.

2. Known hypersensitivity or previous allergic reaction to any constituent of the
Investigational Product (i.e., essential oils, choline, phosphatidylcholine, glycerol,
propylene glycol, polyethylene glycol).

3. Any transient flushing syndrome.

4. Severe atopic dermatitis.

5. Unstable course of atopic dermatitis (spontaneous improvement over time).

6. Skin infections (bacterial, fungal or viral) that can interfere with reliable atopic
dermatitis assessments.

7. Basal cell carcinoma within 6 months of Baseline (Visit 1).

8. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or
ichthyosis or presence of Netherton's syndrome, immunological deficiencies or
diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically
significant severe renal insufficiency, or severe hepatic disorders.

9. Use within 1 month prior to Baseline of 1) oral or intravenous corticosteroids, 2)
UVA/UVB therapy, 3) PUVA (Psoralen plus UltraViolet A) therapy, 4) tanning booths, 5)
non-prescription UV light sources, 6) immunomodulators or immunosuppressive therapies,
7) interferon, 8) cytotoxic drugs, 9) crisaborole, 10) pimecrolimus, or 11) injectable
biologics (e.g. Dupixent).

10. Use within 14 days of Baseline of: 1) systemic antibiotics, 2) systemic JAnus Kinase
(JAK) products, 3) calcipotriene or other vitamin D preparations, or 4) retinoids.

11. Use within 7 days prior to Baseline of: 1) antihistamines, 2) topical antibiotics, 3)
topical corticosteroids or 4) other topical drug products.

12. Use within 24 hours prior to Baseline of any topical product (e.g., sunscreens,
lotions, creams, emollients, moisturizers) in the areas to be treated.

13. Known allergy or hypersensitivity to tofacitinib or any other component of the
Investigational Product (i.e., essential oils, choline, phosphatidylcholine, glycerol,
propylene glycol, polyethylene glycol).

14. Uncontrolled systemic disease.

15. Foreseen unprotected and intense/excessive UV exposure during the study.

16. Scheduled or planned surgical procedures during the study.

17. Unable or unwilling to comply with any of the study requirements.

18. Medical or psychiatric conditions, or a personal situation, that may increase the risk
associated with study participation or may interfere with interpretation of study
results or subject compliance and, in the opinion of the Principal Investigator, makes
the subject inappropriate for study entry.

19. Clinically significant alcohol or drug abuse, or history of poor cooperation or
unreliability.