A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis

NCT06923228 | Completed Phase 2 FDA Drug

• 1 other identifier: CGB-500-05
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if drug CGB-500 works to treat atopic dermatitis in subjects 12 years of age or older. It will also learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 decrease the severity of atopic dermatitis on the skin? What medical problems do participants have when taking drug CGB-500? Researchers will compare CGB-500 to a an approved product (1.5% ruxolitinib) to see if CGB-500 works to treat atopic dermatitis. Participants will: Apply CGB-500 and ruxolitinib to different locations on their body twice a day for four weeks. Visit the clinic six times for checkups and tests Keep a diary of their symptoms and when they apply the product

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (2)

• evaluate effectiveness

  To evaluate percent change in localized eczema area severity by using the Localized Eczema Area Severity Index (L-EASI) score from Baseline to week 4.

  From enrollment to end of study at 4 weeks

• Safety and tolerability

  Overall Incidence of safety events tabulated using the current version of the medical dictionary for regulatory activities (MedDRA).

  From enrollment to end of study at 4 weeks

Study Arms (2)

CGB 500 ointment with 1% tofacitinib

EXPERIMENTAL

topical ointment

Drug: CGB-500 Ointment with 1% tofacitinib

ruxolitinib cream QD

ACTIVE COMPARATOR

topical cream

Drug: Ruxolitinib 1.5% Cream QD

Interventions

CGB-500 Ointment with 1% tofacitinib DRUG

experimental drug

CGB 500 ointment with 1% tofacitinib

Ruxolitinib 1.5% Cream QD DRUG

topical cream

ruxolitinib cream QD

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient, male or female of any race, 12 years of age or older. Females of childbearing potential (FOBCP) must have a negative urine pregnancy test at Screening and Baseline and practice a reliable method of contraception throughout the trial.
• \. Have a clinical diagnosis of atopic dermatitis (AD) for at least 12 months prior to Baseline that has been clinically stable disease for ≥ 3 months at the time of the screening visit and prior to dose administration and is confirmed to be AD according to the criteria of Hanifin and Rajka 3. Have an Investigator Global Assessment (IGA) score of 3 (moderate) at Screening and Baseline, conducted for both sides of the body.
• \. Have AD lesions/symptoms covering at least 2% but less than 20% of total body BSA (excluding scalp, genitalia, palms, and soles) at Screening and Baseline.
• \. Have at least 2 distinct "target treatment areas," one on the right side of the body and one on the left, each covering ≥1% but ≤10% BSA at Screening and Baseline. Multiple target areas are acceptable on each side of the body. Target treatment areas must be representative of the participant's disease state and not be located on the scalp, genitalia, palms, or soles.
• \. In general, good health as determined by medical history and physical examination at the time of screening (investigator discretion).
• \. Have Peak Pruritus Numeric Rating Scale (PPNRS) score of ≥ 4 on the scale 0 to 10 at Screening and Baseline, assessed for both sides of the body.
• \. Be able to follow trial instructions and likely to complete all required visits.
• \. Sign the Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form (ICF, which includes HIPAA) and assent prior to any trial-related procedures being performed.-

You may not qualify if:

• Females who are pregnant, breastfeeding, intending to be pregnant during the trial, or who do not agree to use an acceptable form of birth control during the trial if of childbearing potential 2. Immunocompromised individuals as adjudicated by the principal investigator (PI) based on review of medical history.
• \. Known hypersensitivity or previous allergic reaction to any constituent of the IP (e.g., tofacitinib or Janus kinase \[JAK\] inhibitors, essential oils, choline, phosphatidylcholine, glycerol, propylene glycol, polyethylene glycol).
• \. Clinically significant safety labs (hematology, chemistry, and urinalysis) at the Screening visit that, in the opinion of the investigator, would preclude participation in the study or affect proper assessment of the study endpoints.
• \. Skin infections (e.g., bacterial, fungal or viral) or conditions that can interfere with reliable AD assessments.
• \. Basal cell carcinoma within 6 months prior to Baseline. 7. History of significant skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, uncontrolled diabetes, malignancy, or serious active or recurrent infection.
• \. Participants who have previously failed or had an inadequate response to oral, systemic or topical JAK inhibitors, including in a trial or under a prescription for AD (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
• \. Use within 14 days prior to Baseline of: 1) systemic antibiotics, 2) calcipotriene or 3) retinoids.
• \. Has known hepatic impairment or disorder with aspartate aminotransferase (AST)/alanine amino transferase (ALT) \> 3x upper limit of normal (ULN) at Screening.
• \. Has unstable and impaired renal function with an estimated glomerular filtration rate (eGFR) \<60 mL/min using Cockcroft-Gault (C-G) equation (eGFR between 60 to \<90 mL/min or higher is acceptable; Section 13.2).
• \. Use within 4 weeks prior to Baseline of moderate to strong CYP3A4 and CYP3A5 inhibitors (e.g. ritonavir, clarithromycin, itraconazole, erythromycin, fluconazole, verapamil, ketoconazole, nefazodone, nelfinavir, diltiazem, ciprofloxacin, grapefruit juice).
• \. Use within 7 days on the treatment area(s) prior to Baseline of: 1) topical antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.
• \. Use of the following treatments prior to Baseline:
• For 5 half-lives or 12 weeks (whichever is longer) - biologic agents (e.g., dupilumab).
• For 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g., mycophenolate or tacrolimus).
• For 2 weeks - UVA/UVB therapy, PUVA (psoralen plus ultraviolet) therapy, tanning booths, or non-prescription UV light sources.

Sponsors & Collaborators

• CAGE Bio Inc.: lead

Study Sites (1)

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tofacitinib; ruxolitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: April 21, 2025
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 1, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)