Loading clinical trials...

RECRUITINGPHASE2

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

Safety and Effectiveness of CGB-500 Topical Ointment with 0.5% and 1% Tofacitinib for the Treatment of Atopic Dermatitis: a Randomized, Dose-Ranging, Vehicle-Controlled, Double-Blind Trial

NCT06810050•CAGE Bio Inc.

View on ClinicalTrials.gov

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.

Detailed Description

The primary objectives of this study: * To evaluate the safety and tolerability of CGB-500 topical ointment with 0.5% and 1% tofacitinib for the treatment of atopic dermatitis (AD) * To evaluate the effectiveness of CGB-500 topical ointment with 0.5% and 1% tofacitinib for the treatment of AD Key trial design: Intervention Model: Parallel-group Population Type: Pediatric and adult participants Control: Vehicle (without tofacitinib) Population Diagnosis or Condition: Atopic dermatitis Active Comparator: N/A Population Age: ≥ 12 years Trial Intervention Assignment Method: Randomization Site Distribution: US multicenter Number of Arms: 3 Blinding: participants and investigational staff (sponsor, investigator, and evaluators) Number of Participants: 160 to 180 Arms and Duration: Total duration of trial intervention for each participant: 8 weeks Total duration of trial participation for each participant: Approximately 10 weeks, 2 weeks of screening and 8 weeks of treatment Arms and Duration Description: All participants will undergo approximately 2 weeks (Day -15 to Day -1) of screening and 8 weeks of treatment and will be randomized in a 1:1:1 ratio to the following treatment arms. The goal is to randomize 60 participants with a minimum of 48 participants in each of the arms. * CGB-500 Topical Ointment with 0.5% Tofacitinib BID * CGB-500 Topical Ointment with 1% Tofacitinib BID * Vehicle for CGB-500 Topical Ointment BID

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•To be eligible to participate in this trial, an individual must meet all of the following criteria:
•1. 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.
•2. 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 IGA (Investigator's Global Assessment) score of 2, 3, or 4 at Screening and Baseline.
•4. 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.
•5. 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.
•6. In general, good health as determined by medical history and physical examination at the time of screening (investigator discretion).
•7. Have peak pruritus numeric rating scale (PPNRS) score of ≥ 4 on the scale 0 to 10 at Screening and Baseline.
•8. Be able to follow trial instructions and likely to complete all required visits.
•9. Sign the institutional review board (IRB)-approved informed consent form (ICF, which includes HIPAA) and assent prior to any trial-related procedures being performed.

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this trial:
•1. 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.
•3. 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).
•4. 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
•5. Skin infections (e.g., bacterial, fungal or viral) that can interfere with reliable AD assessments.
•6. Basal cell carcinoma within 6 months prior to Baseline.
•7. 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.
•8. Known hepatic impairment or disorder and/or ALT and AST \>3X ULN at Screening.
•9. 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).
+24 more criteria

Locations (16)

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

Key Dates

Start Date

December 18, 2024

Primary Completion Date

August 30, 2025

Completion Date

October 30, 2025

Last Updated

February 5, 2025

Enrollment

180

ESTIMATED participants

Conditions

Atopic Dermatitis (AD)

Interventions

CGB-500 with 0.5% tofacitinib

DRUG

CGB-500 Ointment with 1% tofacitinib

DRUG

Vehicle (placebo)

DRUG

Contacts

Nitin Joshi, Ph.D.

CONTACT

650-996-1845 njoshi@cagebio.com

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

NCT07298395

Atopic Dermatitis (AD)

View study

RECRUITINGPHASE1

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

NCT07235384

Atopic Dermatitis (AD)

View study

RECRUITINGNA

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Herbal Ointment in Treating Atopic Dermatitis Topically

Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis

Study of ENV-294 in Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis