Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis (AD)

In brief

The goal of this clinical trial is to learn if CGB-500 works to treat atopic dermatitis in participants ages 12 and older. The goal is also to learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 improve atopic dermatitis by decreasing the area affected and the severity of the lesions? What medical problems do participants have when taking CGB500? Researchers will compare CGB-500 to a placebo (a look-alike substance that contains no drug) to see if CGB-500 works to treat atopic dermatitis. Participants will: Take CGB-500 or a placebo every day for 8 weeks. Visit the clinic once every 2 weeks for the first month and at the end of 8 weeks. Keep a diary of when they use the product and complete a form about their symptoms including itching.

Key facts

Study ID

NCT06810050

Run by

CAGE Bio Inc.

People needed

180

Starts

2024-12-18

Expected to finish

2025-10-30

Last updated by the study team

2026-04-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible to participate in this trial, an individual must meet all of the following criteria:
• 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.
• Have an IGA (Investigator's Global Assessment) score of 2, 3, or 4 at Screening and Baseline.
• Have AD lesions/symptoms covering at least 1% but less than 10% of total BSA (excluding scalp, genitalia, palms, and soles) at Screening and Baseline.
• Have at least 1 "target lesion" that measures approximately 10 cm2 or more at Screening and Baseline. Lesion 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.
• Be able to follow trial instructions and likely to complete all required visits.
• Sign the institutional review board (IRB)-approved informed consent form (ICF, which includes HIPAA) and assent prior to any trial-related procedures being performed.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this trial:
• 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 .
• 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).
• Has 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) that can interfere with reliable AD assessments.
• Basal cell carcinoma within 6 months prior to Baseline.
• History of confounding 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.
• Known hepatic impairment or disorder and/or ALT and AST >3X 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/minute or higher is acceptable).
• Use of moderate to strong CYP3A4 and CYP3A5 inhibitors (e.g. ritonavir, clarithromycin, itraconazole, erythromycin, fluconazole, verapamil, ketoconazole, nefazodone, nelfinavir, diltiazem, ciprofloxacin, grapefruit juice) within 4 weeks prior to Baseline.
• 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 atopic dermatitis (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
• Participants who had an adequate response to JAK inhibitors will be excluded if the following are met:
• Use within 2 weeks prior to Baseline of topical JAK inhibitors.
• Use within 4 weeks prior to Baseline of systemic JAK inhibitors.
• Use within 14 days prior to Baseline of: 1) systemic antibiotics, 2) calcipotriene or 3) retinoids.
• 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.
• For 2 weeks - immunizations and sedating antihistamines unless on long-term stable regimen (nonsedating antihistamines are permitted).
• For 2 weeks - use of other topical treatments for atopic dermatitis (other than bland emollients). Diluted sodium hypochlorite "bleach" baths are allowed if they do not exceed 2 baths per week and their frequency remains the same throughout the trial.
• Uncontrolled systemic disease.
• Any serious illness or condition(s) that, in the opinion of the PI, would interfere with full participation in the trial, including administration of IP and attending required trial visits; pose a significant risk to the participant; or interfere with interpretation of trial data.

Where it is running

• Center for Dermatology Clinical Research Inc. — Fremont, California, United States
• Ablon Skin Institute and Research Center — Manhattan Beach, California, United States
• TCR Medical Corporation — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• USA and International Research Inc. — Doral, Florida, United States
• FXM Clinical Research — Fort Lauderdale, Florida, United States
• Driven Research — Gables, Florida, United States
• FXM Clinical Research Miami, LLC — Miami, Florida, United States
• FXM Clinical Research Miramar, LLC — Miramar, Florida, United States
• Cordova Research Institute — Sweetwater, Florida, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Metro Boston Clinical Partners — Brighton, Massachusetts, United States
• J&S Studies, Inc. — New Brighton, Minnesota, United States
• JDR Dermatology Research — Las Vegas, Nevada, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• DermResearch — Austin, Texas, United States

Full record on ClinicalTrials.gov

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