NCT05034822

Study of Ruxolitinib Cream in Children With Atopic Dermatitis

A Maximum Use (MUsT) Pediatric Study of 1.5% Ruxolitinib Cream in Children (Ages ≥ 2 Years to < 12 Years) With Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label maximum use trial to evaluate ruxolitinib safety, tolerability and blood levels after its topical application twice daily to affected areas (≥ 35% BSA) in pediatric participants with atopic dermatitis (AD) and to determine if its systemic bioavailability results in any adverse events.

Detailed description

Open-label, BID application to all affected areas identified at BSLN for 4 weeks (maximum use trial (MUsT) period). The next 4 weeks (treatment extension period) will be applied BID to active lesions only for the next 4 weeks for a total treatment period of 8 weeks. Eligible participants will be offered option to continue into 44-wk LTS period of BID to treat as-needed to active lesions. All participants will have 30 day safety follow-up visit.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Ruxolitinib cream	Ruxolitinib 1.5% cream applied twice daily.

Timeline

• Start date: 2021-12-16
• Primary completion: 2023-08-07
• Completion: 2023-08-07
• First posted: 2021-09-05
• Last updated: 2023-09-15

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study