Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
Study NCT ID:
NCT06810050
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2025-01-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis
Sponsor:
CAGE Bio Inc.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: