Atopic DermatitisPhase 1/2NCT05487963
Tolerability and Effectiveness of CGB-500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis
A Phase 1/2 study testing Tofacitinib Citrate in people with Atopic Dermatitis, run by CAGE Bio Inc. at 1 site in Georgia.
Trial summary
The objective of the proposed study is to evaluate the tolerability and effectiveness of a 1% topical ointment of tofacitinib for the treatment of mild to moderate atopic dermatitis in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Tofacitinib Citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGeorgia
- Study dates
- 9 Nov 2022to 30 Jul 2023
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
- Have a clinical diagnosis of atopic dermatitis for at least 6 months prior to Day 0 (at the Screening and Baseline visit) that has been clinically stable for ≥3 months prior to dose administration and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
- Have an IGA score of 2 (mild) or 3 (moderate) at Day 0.
- Have an EASI score of 1.1 to 12.0 (i.e., mild or moderate).
- Have atopic dermatitis on the arms and other body parts covering at least 2% of total BSA and up to and including 12% of total Body Surface Area (BSA) at Day 0.
- Have a presence of 1 to 3 target atopic dermatitis lesions of total surface area of 15 to 30 cm2, located on the body part visible to the subject. This is the target lesion(s) that will be treated in this study.
Show all 12Show fewer
- Agree to use only low potency corticosteroid (up to 1% hydrocortisone) topical cream or ointment for the other affected parts of the body that are not being treated with the investigational product in the study, and at least 5 cm away from the treated area.
- In general, good health as determined by medical history and physical examination at the time of screening (Investigator discretion).
- Have a Peak Pruritus NRS score of ≥30 on the of scale 0 to 100, especially on the target lesions.
- Ability to follow study instructions and likely to complete all required visits.
- Have signed the Institutional Review Board (IRB)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
- Participating in any other clinical trial from 30 days prior to Screening and throughout the planned 12-week study period.
Who cannot join
- Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
- Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Product (i.e., essential oils, choline, phosphatidylcholine, glycerol, propylene glycol, polyethylene glycol).
- Any transient flushing syndrome.
- Severe atopic dermatitis.
- Unstable course of atopic dermatitis (spontaneous improvement over time).
- Skin infections (bacterial, fungal or viral) that can interfere with reliable atopic dermatitis assessments.
Show all 19Show fewer
- Basal cell carcinoma within 6 months of Baseline (Visit 1).
- History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis or presence of Netherton's syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency, or severe hepatic disorders.
- Use within 1 month prior to Baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) PUVA (Psoralen plus UltraViolet A) therapy, 4) tanning booths, 5) non-prescription UV light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) crisaborole, 10) pimecrolimus, or 11) injectable biologics (e.g. Dupixent).
- Use within 14 days of Baseline of: 1) systemic antibiotics, 2) systemic JAnus Kinase (JAK) products, 3) calcipotriene or other vitamin D preparations, or 4) retinoids.
- Use within 7 days prior to Baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.
- Use within 24 hours prior to Baseline of any topical product (e.g., sunscreens, lotions, creams, emollients, moisturizers) in the areas to be treated.
- Known allergy or hypersensitivity to tofacitinib or any other component of the Investigational Product (i.e., essential oils, choline, phosphatidylcholine, glycerol, propylene glycol, polyethylene glycol).
- Uncontrolled systemic disease.
- Foreseen unprotected and intense/excessive UV exposure during the study.
- Scheduled or planned surgical procedures during the study.
- Unable or unwilling to comply with any of the study requirements.
- Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with study participation or may interfere with interpretation of study results or subject compliance and, in the opinion of the Principal Investigator, makes the subject inappropriate for study entry.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerability and Effectiveness of CGB 500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis: a Randomized, Double-Blind, Vehicle-Controlled Study
The objective of the proposed study is to evaluate the tolerability and effectiveness of a 1% topical ointment of tofacitinib for the treatment of mild to moderate atopic dermatitis in adults. Adult patients with a diagnosis of atopic dermatitis for at least 6 months will be treated with the test product or placebo for a period of 8 weeks with a follow-up visit at 12 weeks. The primary endpoints are safety and tolerability of CGB-500 Ointment and a comparison of effectiveness of CGB-500 Ointment and Vehicle Ointments in treating lesion(s) of mild to moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Tofacitinib Citrate, placebo ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib CitrateDrug
Topical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day.
placebo ointmentOther
Topical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day.
| Study group | Role | What they receive |
|---|---|---|
| CGB-500 topical ointment, 1% tofacitinib | Experimental | Not described Receives: Drug: Tofacitinib Citrate |
| Vehicle topical ointment | Placebo comparator | Not described Receives: Other: placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Frequency of subjects with Treatment-Emergent Adverse Events (TEAEs).
- Frequency of subjects with skin irritation TEAEs and any other adverse skin reactions.
Measured: 8 weeks
Effectiveness
Percent change from baseline in lesional Eczema Area and Severity Index (EASI) score at Week 8. EASI is scored on a 0 - 6 scale with 0 being no eczema and 6 being 100% of the area affected by eczema.
Measured: 8 weeks
Secondary outcomes (3)
Investigator's Global Assessment (IGA)
Percentage of subjects achieving Investigator's Global Assessment (IGA) response of 'Clear' (Score 0) or 'Almost Clear' (Score 1) at Week 8.
Measured: 8 weeks
Eczema Area and Severity Index (EASI)
Percentage of subjects who achieve a ≥75% improvement from baseline in lesional EASI score at Week 8
Measured: 8 weeks
Pruritis
Change from baseline in peak lesional pruritus (itching) Numeric Rating Scale (NRS) score at Week 8. NRS goes from 0 to 10; with 0 signifying no itching and 10 signifying worst itch imaginable.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start9 Nov 2022
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT05487963
- Sponsor's protocol ID
- CGB-500-001
- Status last verified
- May 2024
- First submitted
- 1 Aug 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Effectiveness of CGB 500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis: a Randomized, Double-Blind, Vehicle-Controlled Study
- ClinicalTrials.gov ID
- NCT05487963
- Acronym / sponsor ID
- CGB-500-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 4 Aug 2022 (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 objective of the proposed study is to evaluate the tolerability and effectiveness of a 1% topical ointment of tofacitinib for the treatment of mild to moderate atopic dermatitis in adults. Adult patients with a diagnosis of atopic dermatitis for at least 6 months will be treated with the test product or placebo for a period of 8 weeks with a follow-up visit at 12 weeks. The primary endpoints are safety and tolerability of CGB-500 Ointment and a comparison of effectiveness of CGB-500 Ointment and Vehicle Ointments in treating lesion(s) of mild to moderate atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGB-500 topical ointment, 1% tofacitinib | Experimental | Drug: Tofacitinib Citrate |
| Vehicle topical ointment | Placebo comparator | Other: placebo ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
- Have a clinical diagnosis of atopic dermatitis for at least 6 months prior to Day 0 (at the Screening and Baseline visit) that has been clinically stable for ≥3 months prior to dose administration and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
- Have an IGA score of 2 (mild) or 3 (moderate) at Day 0.
- Have an EASI score of 1.1 to 12.0 (i.e., mild or moderate).
- Have atopic dermatitis on the arms and other body parts covering at least 2% of total BSA and up to and including 12% of total Body Surface Area (BSA) at Day 0.
Key exclusion criteria (19 listed)
- Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
- Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Product (i.e., essential oils, choline, phosphatidylcholine, glycerol, propylene glycol, polyethylene glycol).
- Any transient flushing syndrome.
- Severe atopic dermatitis.
- Unstable course of atopic dermatitis (spontaneous improvement over time).
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 |
|---|---|---|
| Tofacitinib CitrateTopical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day. | Drug | CGB-500 topical ointment, 1% tofacitinib |
| placebo ointmentTopical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day. | Other | Vehicle topical ointment |
Primary outcome
Safety and Tolerability
Time frame: 8 weeks
Frequency of subjects with Treatment-Emergent Adverse Events (TEAEs). • Frequency of subjects with skin irritation TEAEs and any other adverse skin reactions.
Effectiveness
Time frame: 8 weeks
Percent change from baseline in lesional Eczema Area and Severity Index (EASI) score at Week 8. EASI is scored on a 0 - 6 scale with 0 being no eczema and 6 being 100% of the area affected by eczema.
3 secondary outcomes
Investigator's Global Assessment (IGA)
Time frame: 8 weeks
Eczema Area and Severity Index (EASI)
Time frame: 8 weeks
Pruritis
Time frame: 8 weeks
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 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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 1/2 study testing Tofacitinib Citrate in people with Atopic Dermatitis, run by CAGE Bio Inc. at 1 site in Georgia.
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 12 inclusion and 19 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 13 Feb 2025. 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 Georgia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: 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 13 Feb 2025.