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NCT06810050
Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis
Phase 2 trial testing CGB-500 with 0.5% tofacitinib in Atopic Dermatitis (AD) in 180 participants. Completed in 30 October 2025.
30 August 2025
Quick facts
| Lead sponsor | CAGE Bio Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 18 December 2024 |
| Primary completion | 30 August 2025 |
| Estimated completion | 30 October 2025 |
| Sites | 16 locations across United States |
Drugs / interventions tested
- CGB-500 with 0.5% tofacitinib — full drug profile →
- CGB-500 Ointment with 1% tofacitinib — full drug profile →
- Vehicle (placebo)
Conditions studied
- Atopic Dermatitis (AD) — all drugs for Atopic Dermatitis (AD) →
Sponsor
CAGE Bio Inc. — full company profile →
Who can join
12 and older, any sex, with Atopic Dermatitis (AD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06810050
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atopic Dermatitis (AD)
Currently open trials in the same condition.
- NCT07146971 — Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis · Phase 1 · recruiting
- NCT07235384 — A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participan · Phase 1 · recruiting
- NCT07259343 — Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization · NA · recruiting
- NCT07021495 — SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY) · recruiting
- NCT07105488 — A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis · Phase 2 · recruiting
Other CAGE Bio Inc. trials
Trials by the same sponsor.
- NCT07357870 — A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo · Phase 1 · recruiting
- NCT06923228 — A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis · Phase 2 · completed
- NCT05487963 — Tolerability and Effectiveness of CGB-500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis · Phase 1, PHASE2 · completed
- NCT05202366 — An Open-label Study Evaluating the Effectiveness of CGB-400 Topical Gel for Fungal Infection · completed
- NCT04886739 — CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06810050 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CAGE Bio Inc.
- Last refreshed: 2 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06810050.
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