A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

• Status: Not yet recruiting
• Trial end date: 2025-12-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Clinical diagnosis of PN ≥ 3 months before screening.

• ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area <20% BSA.

• IGA-CPG-S score of ≥ 2 at screening and baseline.

• Baseline PN-related WI-NRS score ≥ 7.

• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Chronic pruritus due to a condition other than PN

• Total estimated BSA treatment area (excluding the scalp) > 20%.

• Neuropathic and psychogenic pruritus

• Active atopic dermatitis lesions within 3 months of screening and baseline.

• Uncontrolled thyroid function

• Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.

• Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.

• Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline

• Pregnant or lactating, or considering pregnancy.

• History of alcoholism or drug addiction within 1 year

• Known allergy or reaction to any of the components of the study drug.

• Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.

• Employees of the sponsor or investigator or otherwise dependents of them.

• The following participants are excluded in France:

1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.

2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.

3. Individuals not affiliated with the social security system.