A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream

Conditions

• Prurigo Nodularis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib Cream 1.5% — DRUG
  Ruxolitinib Cream 1.5%

Study Details

This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).

Key Dates

Start date

Feb 27, 2024

Status verified

Aug 2025

Primary completion

Jul 17, 2025

Completion

Jul 17, 2025

Study Design

Enrollment

23 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Maximal Use Ruxolitinib 1.5%
  Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions.

Primary Outcome Measure

Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 16 weeks, including 30 days of safety follow-up ]

Locations (20)

Find similar trials in Phoenix, AZ

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