Atopic Dermatitis (AD)Phase 2NCT06923228
A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis
A Phase 2 study testing CGB-500 Ointment with 1% tofacitinib and Ruxolitinib 1.5% Cream QD in people with Atopic Dermatitis (AD), run by CAGE Bio Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- CGB-500 Ointment with 1% tofacitinib and Ruxolitinib 1.5% Cream QD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 Investigator Global Assessment (IGA) score of 3 (moderate) at Screening and Baseline, conducted for both sides of the body.
- 4. 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.
- 5. 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.
- 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, assessed for both sides of the body.
- 8. Be able to follow trial instructions and likely to complete all required visits.
- 9. 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.-
Who cannot join
- 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. 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) or conditions that can interfere with reliable AD assessments.
- 6. 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.
- 8. 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).
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- 9. Use within 14 days prior to Baseline of: 1) systemic antibiotics, 2) calcipotriene or 3) retinoids.
- 10. Has known hepatic impairment or disorder with aspartate aminotransferase (AST)/alanine amino transferase (ALT) > 3x upper limit of normal (ULN) at Screening.
- 11. 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).
- 12. 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).
- 13. 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.
- 14. 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.
- 15. Uncontrolled systemic disease, including Hepatitis B and Hepatitis C. 16. Any illness or condition(s) (including any skin or cardiovascular condition) 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.
- 17. Foreseen unprotected and intense/excessive UV exposure during the trial. 18. Scheduled or planned surgical procedures during the trial. 19. Unable or unwilling to comply with any of the trial requirements. 20. 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.
- 21. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- 22. Employees of the research center or Investigator. 23. Family of members of employees of the research center or Investigator. 24. Participants (e.g. siblings, spouses, relatives, roommates) residing in the same household cannot be enrolled at the same time.
- 25. Previous participation in a CGB-500 clinical study or exposure to CGB-500. Participants who have previously received CGB-500 as part of any clinical trial or investigational study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Dermatology Clinical Research
Fremont, California, 94538
About this study
Official title: A Single-Blind, Prospective Clinical Study to Assess the Efficacy, Safety and Tolerability of CGB-500 1% Tofacitinib Ointment vs. an Active Comparator for Atopic Dermatitis
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.
Read more
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)
- Being tested
- CGB-500 Ointment with 1% tofacitinib, Ruxolitinib 1.5% Cream QD
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGB-500 Ointment with 1% tofacitinibDrug
experimental drug
Ruxolitinib 1.5% Cream QDDrug
topical cream
| Study group | Role | What they receive |
|---|---|---|
| CGB 500 ointment with 1% tofacitinib | Experimental | topical ointment Receives: Drug: CGB-500 Ointment with 1% tofacitinib |
| ruxolitinib cream QD | Active comparator | topical cream Receives: Drug: Ruxolitinib 1.5% Cream QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From enrollment to end of study at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start21 Apr 2025
- Primary completion30 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAGE Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923228
- Sponsor's protocol ID
- CGB-500-05
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Prospective Clinical Study to Assess the Efficacy, Safety and Tolerability of CGB-500 1% Tofacitinib Ointment vs. an Active Comparator for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06923228
- Acronym / sponsor ID
- CGB-500-05
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGB 500 ointment with 1% tofacitinib | Experimental | Drug: CGB-500 Ointment with 1% tofacitinibtopical ointment |
| ruxolitinib cream QD | Active comparator | Drug: Ruxolitinib 1.5% Cream QDtopical cream |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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 Investigator Global Assessment (IGA) score of 3 (moderate) at Screening and Baseline, conducted for both sides of the body.
- 4. 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.
- 5. 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.
- 6. In general, good health as determined by medical history and physical examination at the time of screening (investigator discretion).
Key exclusion criteria (22 listed)
- 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. 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) or conditions that can interfere with reliable AD assessments.
- 6. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGB-500 Ointment with 1% tofacitinibexperimental drug | Drug | CGB 500 ointment with 1% tofacitinib |
| Ruxolitinib 1.5% Cream QDtopical cream | Drug | ruxolitinib cream QD |
Primary outcome
evaluate effectiveness
Time frame: From enrollment to end of study at 4 weeks
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.
Safety and tolerability
Time frame: From enrollment to end of study at 4 weeks
Overall Incidence of safety events tabulated using the current version of the medical dictionary for regulatory activities (MedDRA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CGB-500 Ointment with 1% tofacitinib and Ruxolitinib 1.5% Cream QD in people with Atopic Dermatitis (AD), run by CAGE Bio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate effectiveness (time frame: From enrollment to end of study at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.