Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Condition or Disease
Prurigo
Detailed Description
The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Estimated Enrollment: | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis |
| Actual Study Start Date: | March 10, 2023 |
| Estimated Primary Completion Date: | August 7, 2024 |
| Estimated Study Completion Date: | December 3, 2025 |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
- Vulnerable populations according to article L.1121-6 of the French Public Health Code.
- Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
- Individuals not affiliated with the social security system.