RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-18

Study Completion:2025-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06810050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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). 10. 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. 11. 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). 12. Participants who had an adequate response to JAK inhibitors will be excluded if the following are met: 1. Use within 2 weeks prior to Baseline of topical JAK inhibitors. 2. Use within 4 weeks prior to Baseline of systemic JAK inhibitors. 13. Use within 14 days prior to Baseline of: 1) systemic antibiotics, 2) calcipotriene or 3) retinoids. 14. 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. 15. Use of the following treatments prior to Baseline: 1. For 5 half-lives or 12 weeks (whichever is longer) - biologic agents (e.g., dupilumab). 2. For 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g., mycophenolate or tacrolimus). 3. For 2 weeks - UVA/UVB therapy, PUVA (psoralen plus ultraviolet) therapy, tanning booths, or non-prescription UV light sources. 4. For 2 weeks - immunizations and sedating antihistamines unless on long-term stable regimen (nonsedating antihistamines are permitted). 5. 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. 16. Uncontrolled systemic disease. 17. 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. 18. Foreseen unprotected and intense/excessive UV exposure during the trial. 19. Scheduled or planned surgical procedures during the trial. 20. Unable or unwilling to comply with any of the trial requirements. 21. Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with trial participation or may interfere with interpretation of trial results or participant compliance and, in the opinion of the PI, makes the participant inappropriate for trial entry. 22. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. 23. Employees of the research center or Investigator. 24. Family of members of employees of the research center or Investigator. 25. Participants (e.g. siblings, spouses, relatives, roommates) residing in the same household cannot be enrolled at the same time.

Inclusion Criteria

Exclusion 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.

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).
10. 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.
11. 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).
12. Participants who had an adequate response to JAK inhibitors will be excluded if the following are met:
1. Use within 2 weeks prior to Baseline of topical JAK inhibitors.
2. Use within 4 weeks prior to Baseline of systemic JAK inhibitors.
13. Use within 14 days prior to Baseline of: 1) systemic antibiotics, 2) calcipotriene or 3) retinoids.
14. 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.
15. Use of the following treatments prior to Baseline:
1. For 5 half-lives or 12 weeks (whichever is longer) - biologic agents (e.g., dupilumab).
2. For 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g., mycophenolate or tacrolimus).
3. For 2 weeks - UVA/UVB therapy, PUVA (psoralen plus ultraviolet) therapy, tanning booths, or non-prescription UV light sources.
4. For 2 weeks - immunizations and sedating antihistamines unless on long-term stable regimen (nonsedating antihistamines are permitted).
5. 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.
16. Uncontrolled systemic disease.
17. 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.
18. Foreseen unprotected and intense/excessive UV exposure during the trial.
19. Scheduled or planned surgical procedures during the trial.
20. Unable or unwilling to comply with any of the trial requirements.
21. Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with trial participation or may interfere with interpretation of trial results or participant compliance and, in the opinion of the PI, makes the participant inappropriate for trial entry.
22. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
23. Employees of the research center or Investigator.
24. Family of members of employees of the research center or Investigator.
25. Participants (e.g. siblings, spouses, relatives, roommates) residing in the same household cannot be enrolled at the same time.

Contacts and Locations

Study Contact

Nitin Joshi, Ph.D.

CONTACT

650-996-1845

njoshi@cagebio.com

Study Locations (Sites)

Center for Dermatology Clinical Research Inc.

Fremont, California, 94538

United States

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266

United States

TCR Medical Corporation

San Diego, California, 92123

United States

Syrentis Clinical Research

Santa Ana, California, 92705

United States

USA and International Research Inc.

Doral, Florida, 33126

United States

FXM Clinical Research

Ft. Lauderdale, Florida, 33308

United States

Driven Research

Gables, Florida, 33134

United States

FXM Clinical Research Miami, LLC

Miami, Florida, 33175

United States

FXM Clinical Research Miramar, LLC

Miramar, Florida, 33027

United States

Cordova Research Institute

Sweetwater, Florida, 33182

United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168

United States

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135

United States

J&S Studies, Inc.

New Brighton, Minnesota, 55112

United States

JDR Dermatology Research

Las Vegas, Nevada, 89148

United States

Tennessee Clinical Research Center

Nashville, Tennessee, 37215

United States

DermResearch

Austin, Texas, 78759

United States

Collaborators and Investigators

Sponsor: CAGE Bio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-18

Study Completion Date2025-10-30

Study Record Updates

Study Start Date2024-12-18

Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Atopic Dermatitis (AD)