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

NCT06810050 | Completed Phase 2 FDA Drug

• 1 other identifier: CGB-500-04
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Atopic Dermatitis (AD)

Keywords

Phase 2b study, study the safety and effectiveness of CGB-500 topical ointment with 0.5% and 1% tofacitinib,

Outcome Measures

Primary Outcomes (2)

• 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 8 weeks

• evaluate effectiveness

  Primary Efficacy Endpoint • Proportion of participants achieving Investigator's Global Assessment (IGA) response of "Clear" (Score 0) or "Almost Clear" (Score 1) with ≥ 2 grade of improvement at Week 8.

  From enrollment to end of study at 8 weeks

Study Arms (3)

CGB 500 ointment with 0.5% tofacitinib

EXPERIMENTAL

Drug: CGB-500 with 0.5% tofacitinib

CGB 500 ointment with 1% tofacitinib

EXPERIMENTAL

Drug: CGB-500 Ointment with 1% tofacitinib

vehicle ointment

PLACEBO COMPARATOR

Drug: Vehicle (placebo)

Interventions

CGB-500 with 0.5% tofacitinib DRUG

CGB-500 is a proprietary ointment formulation

CGB 500 ointment with 0.5% tofacitinib

CGB-500 Ointment with 1% tofacitinib DRUG

CGB-500 is a proprietary ointment formulation

CGB 500 ointment with 1% tofacitinib

Vehicle (placebo) DRUG

placebo ointment

vehicle ointment

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:

• 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.

Sponsors & Collaborators

• CAGE Bio Inc.: lead

Study Sites (16)

Center for Dermatology Clinical Research Inc.

Fremont, California, 94538, United States

Location

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

Location

TCR Medical Corporation

San Diego, California, 92123, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

USA and International Research Inc.

Doral, Florida, 33126, United States

Location

FXM Clinical Research

Fort Lauderdale, Florida, 33308, United States

Location

Driven Research

Gables, Florida, 33134, United States

Location

FXM Clinical Research Miami, LLC

Miami, Florida, 33175, United States

Location

FXM Clinical Research Miramar, LLC

Miramar, Florida, 33027, United States

Location

Cordova Research Institute

Sweetwater, Florida, 33182, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

J&S Studies, Inc.

New Brighton, Minnesota, 55112, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tofacitinib

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 5, 2025
• Study Start: December 18, 2024
• Primary Completion: August 30, 2025
• Study Completion: October 30, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (16)