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A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN1)

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ClinicalTrials.gov Identifier: NCT05755438
Recruitment Status : Recruiting
First Posted : March 6, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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 Intervention/treatment Phase
Prurigo Drug: Ruxolitinib Cream Drug: Vehicle Cream Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Vehicle Cream BID
Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will apply ruxolitinib 1.5% cream topically during the open label extension (OLE) period for up to 40 weeks.
 Drug: Vehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).
Experimental: Ruxolitinib 1.5% Cream
Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will apply ruxolitinib 1.5% cream the open label extension (OLE) period for up to 40 weeks.
 Drug: Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).
Other Name: INCB018424 phosphate cream


Outcome Measures
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Primary Outcome Measures :
  1. Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response [ Time Frame: Week 12 ]
    Defined as achieving a ≥ 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.


Secondary Outcome Measures :
  1. WI-NRS4 Response [ Time Frame: Week 4 ]
    Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.

  2. Overall Treatment Success (TS) [ Time Frame: Week 12 ]
    Defined as achieving both a WI-NRS4 response and an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS).

  3. IGA-CPG-S-TS [ Time Frame: Week 12 ]
    Defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline

  4. WI-NRS4 Response [ Time Frame: Day 7 ]
    Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.

  5. Proportion of participants with WI-NRS4 at each postbaseline visit. [ Time Frame: Up to 52 weeks ]
    Defined as percentage of participants that achieve a ≥ 4-point improvement in WI-NRS score

  6. Change from baseline in WI-NRS score [ Time Frame: Up to 52 weeks ]
    Defined as change in Intensity of itch. Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".

  7. Time to ≥ 2-point improvement from baseline in WI-NRS score [ Time Frame: Up to 52 weeks ]
    Participants rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)

  8. Time to ≥ 4-point improvement from baseline in WI-NRS score [ Time Frame: Up to 52 weeks ]
    Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline

  9. Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score [ Time Frame: Up to 52 weeks ]
    Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".

  10. Change from baseline in Skin Pain NRS score [ Time Frame: Up to 52 weeks ]
    Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".

  11. IGA-TS response, defined as achieving IGA TS at each postbaseline visit. [ Time Frame: Up to 56 weeks ]
    The IGA for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating on on a 5-point scale ranging from 0 (clear skin) to 4 (severe).

  12. IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit. [ Time Frame: Up to 56 weeks ]
    The IGA-CPG-A is an overall PN severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.

  13. > 75% healed lesions from baseline in PAS at each postbaseline visit. [ Time Frame: Up to 56 weeks ]
    PAS includes 5 items; descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions, and disease activity in terms of percentage of pruriginous lesions with excoriations/crusts on top.

  14. Number of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 56 weeks ]
    TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

  15. Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. [ Time Frame: Up to 56 weeks ]
    The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days

  16. Change from baseline in EQ-5D-5L score at each postbaseline visit. [ Time Frame: Up to 56 weeks ]
    The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05755438


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Haq Nawaz, md Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05755438    
Other Study ID Numbers: INCB 18424-319
First Posted: March 6, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Prurigo
Prurigo Nodularis
PN
Skin Diseases
 Dermatitis
Eczematous
ruxolitinib
INCB 18424
Additional relevant MeSH terms:
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Prurigo
Skin Diseases