NCT06810050

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

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: CAGE Bio Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
DRUG	CGB-500 with 0.5% tofacitinib	CGB-500 is a proprietary ointment formulation
DRUG	CGB-500 Ointment with 1% tofacitinib	CGB-500 is a proprietary ointment formulation
DRUG	Vehicle (placebo)	placebo ointment

Timeline

• Start date: 2024-12-18
• Primary completion: 2025-08-30
• Completion: 2025-10-30
• First posted: 2025-02-05
• Last updated: 2026-04-02

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study