Atopic Dermatitis (AD)Phase 2NCT06810050
Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis
A Phase 2 study testing CGB-500 with 0.5% tofacitinib and CGB-500 Ointment with 1% tofacitinib in people with Atopic Dermatitis (AD), run by CAGE Bio Inc. at 16 sites in United States.
Trial 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… 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 with 0.5% tofacitinib and CGB-500 Ointment with 1% tofacitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 16 sitesUnited States
- Study dates
- 18 Dec 2024to 30 Oct 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Foreseen unprotected and intense/excessive UV exposure during the trial.
- Scheduled or planned surgical procedures during the trial.
- Unable or unwilling to comply with any of the trial requirements.
- 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.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- Employees of the research center or Investigator.
- Family of members of employees of the research center or Investigator.
- Participants (e.g. siblings, spouses, relatives, roommates) residing in the same household cannot be enrolled at the same time.
- -
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
DermResearch
Austin, Texas, 78759
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
USA and International Research Inc.
Doral, Florida, 33126
FXM Clinical Research
Fort Lauderdale, Florida, 33308
Center for Dermatology Clinical Research Inc.
Fremont, California, 94538
Driven Research
Gables, Florida, 33134
JDR Dermatology Research
Las Vegas, Nevada, 89148
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
FXM Clinical Research Miami, LLC
Miami, Florida, 33175
FXM Clinical Research Miramar, LLC
Miramar, Florida, 33027
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
J&S Studies, Inc.
New Brighton, Minnesota, 55112
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
TCR Medical Corporation
San Diego, California, 92123
Syrentis Clinical Research
Santa Ana, California, 92705
Cordova Research Institute
Sweetwater, Florida, 33182
About this study
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
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.
Read more
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.
Read the 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
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- CGB-500 with 0.5% tofacitinib, CGB-500 Ointment with 1% tofacitinib, Vehicle (placebo)
- Keywords
- Phase 2b study, study the safety and effectiveness of CGB-500 topical ointment with 0.5% and 1% tofacitinib,
- 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 with 0.5% tofacitinibDrug
CGB-500 is a proprietary ointment formulation
CGB-500 Ointment with 1% tofacitinibDrug
CGB-500 is a proprietary ointment formulation
Vehicle (placebo)Drug
placebo ointment
| Study group | Role | What they receive |
|---|---|---|
| CGB 500 ointment with 0.5% tofacitinib | Experimental | Not described Receives: Drug: CGB-500 with 0.5% tofacitinib |
| CGB 500 ointment with 1% tofacitinib | Experimental | Not described Receives: Drug: CGB-500 Ointment with 1% tofacitinib |
| vehicle ointment | Placebo comparator | Not described Receives: Drug: Vehicle (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: From enrollment to end of study at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start18 Dec 2024
- Primary completion30 Aug 2025
- Study completion30 Oct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
- NCT06810050
- Sponsor's protocol ID
- CGB-500-04
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06810050
- Acronym / sponsor ID
- CGB-500-04
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Phase 2b study, study the safety and effectiveness of CGB-500 topical ointment with 0.5% and 1% tofacitinib,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 5 Feb 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (34 listed)
- 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
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 with 0.5% tofacitinibCGB-500 is a proprietary ointment formulation | Drug | CGB 500 ointment with 0.5% tofacitinib |
| CGB-500 Ointment with 1% tofacitinibCGB-500 is a proprietary ointment formulation | Drug | CGB 500 ointment with 1% tofacitinib |
| Vehicle (placebo)placebo ointment | Drug | vehicle ointment |
Primary outcome
Safety and tolerability
Time frame: From enrollment to end of study at 8 weeks
• Overall Incidence of safety events tabulated using the current version of the medical dictionary for regulatory activities (MedDRA).
evaluate effectiveness
Time frame: From enrollment to end of study at 8 weeks
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.
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 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
16 sites 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 with 0.5% tofacitinib and CGB-500 Ointment with 1% tofacitinib in people with Atopic Dermatitis (AD), run by CAGE Bio Inc. at 16 sites 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 10 inclusion and 34 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 2 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 16 sites 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability (time frame: From enrollment to end of study at 8 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 2 Apr 2026.