Overview

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.