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

Tolerability and Effectiveness of CGB 500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis: A Randomized, Double-Blind, Vehicle-Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Tofacitinib Citrate; Other: placebo ointment

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGB-500 topical ointment, 1% tofacitinib	Drug: Tofacitinib Citrate; Topical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day.
Placebo Comparator: Vehicle topical ointment	Other: placebo ointment; Topical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Frequency of subjects with Treatment-Emergent Adverse Events (TEAEs). • Frequency of subjects with skin irritation TEAEs and any other adverse skin reactions.	8 weeks
Effectiveness	Percent change from baseline in lesional Eczema Area and Severity Index (EASI) score at Week 8. EASI is scored on a 0 - 6 scale with 0 being no eczema and 6 being 100% of the area affected by eczema.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's Global Assessment (IGA)	Percentage of subjects achieving Investigator's Global Assessment (IGA) response of 'Clear' (Score 0) or 'Almost Clear' (Score 1) at Week 8.	8 weeks
Eczema Area and Severity Index (EASI)	Percentage of subjects who achieve a ≥75% improvement from baseline in lesional EASI score at Week 8	8 weeks
Pruritis	Change from baseline in peak lesional pruritus (itching) Numeric Rating Scale (NRS) score at Week 8. NRS goes from 0 to 10; with 0 signifying no itching and 10 signifying worst itch imaginable.	8 weeks

Collaborators and Investigators

• Sponsor: CAGE Bio Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2022
• Primary Completion (Anticipated): March 14, 2023
• Study Completion (Anticipated): April 14, 2023

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: CGB-500-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No