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A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05061693
Recruitment Status : Active, not recruiting
First Posted : September 29, 2021
Last Update Posted : February 28, 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 efficacy and safety of INCB054707 in participants with prurigo nodularis over a 16-week double-blind placebo-controlled treatment period, followed by a 24 -week single blind extension period.

Condition or disease Intervention/treatment Phase
Prurigo Nodularis Drug: INCB054707 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Actual Study Start Date : November 4, 2021
Actual Primary Completion Date : August 11, 2023
Estimated Study Completion Date : April 14, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: INCB054707 Dose A
Participants will receive INCB054707 Dose A for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
 Drug: INCB054707
Oral; Tablet
Other Name: Povorcitinib
Experimental: INCB054707 Dose B
Participants will receive INCB054707 Dose B for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
 Drug: INCB054707
Oral; Tablet
Other Name: Povorcitinib
Experimental: INCB054707 Dose C
Participants will receive INCB054707 Dose C for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
 Drug: INCB054707
Oral; Tablet
Other Name: Povorcitinib
Placebo Comparator: Placebo followed by INCB054707 Dose B or C
Participants will receive placebo for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
 Drug: Placebo
Oral; Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score [ Time Frame: Week 16 ]
    Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".


Secondary Outcome Measures :
  1. Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS) [ Time Frame: Week 16 ]
    Defined as IGA score of 0 or 1 with a ≥ 2-grade improvement from baseline

  2. Time to ≥ 4-point improvement from baseline in Itch NRS score [ Time Frame: Up to Week 48 ]
    Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 48 ]
    A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of PN for at least 3 months before screening.
  • Inadequate response or intolerant to ongoing or prior PN therapy.
  • ≥ 20 pruriginous lesions on ≥ 2 different body regions at screening and Day 1.
  • Willingness to avoid pregnancy or fathering children
  • Further inclusion criteria apply.

Exclusion Criteria:

  • Have chronic pruritus due to a condition other than PN; have neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
  • Current use of a medication known to cause pruritus.
  • Women who are pregnant (or who are considering pregnancy) or lactating.
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
  • Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
  • Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
  • Laboratory values outside of the protocol-defined ranges.
  • Further exclusion criteria apply.
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): NCT05061693


Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kathleen Butler, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05061693    
Other Study ID Numbers: INCB 54707-206
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 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 nodularis
PN
INCB054707
chronic pruritus
Additional relevant MeSH terms:
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Prurigo
Neurodermatitis
Skin Diseases
Dermatitis
Skin Diseases, Eczematous