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

Primary Purpose

Prurigo Nodularis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INCB054707
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prurigo Nodularis focused on measuring Prurigo nodularis, PN, INCB054707, chronic pruritus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of PN for at least 3 months before screening.
  • Inadequate response or intolerant to ongoing or prior PN therapy.
  • ≥ 20 nodules 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.

Sites / Locations

  • Investigative Site US010
  • Investigative Site US024
  • Investigative Site US001
  • Investigative Site US014
  • Investigative Site US019
  • Investigative Site US016
  • Investigative Site US013
  • Investigative Site US009
  • Investigative Site 1071320
  • Investigative Site US008
  • Investigative Site US011
  • Investigative Site US003
  • Investigative Site US017
  • Investigative Site US006
  • Investigative Site US004
  • Investigative Site US023
  • Investigative Site US002
  • Investigative Site US012
  • Investigative Site US022
  • Investigative Site US021
  • Investigative Site US005
  • Investigative Site US018
  • Investigative Site US007
  • Investigative Site CA002
  • Investigative Site CA001
  • Investigative Site CA004
  • Investigative Site CA003
  • Investigative Site DE007
  • Investigative Site DE005
  • Investigative Site DE004
  • Investigative Site DE003
  • Investigative Site DE001
  • Investigative Site DE002
  • Investigative Site DE008
  • Investigative Site PL005
  • Investigative Site PL003
  • Investigative Site PL001
  • Investigative Site PL004
  • Investigative Site PL002
  • Investigative Site PR002
  • Investigative Site PR001
  • Investigative Site ES004
  • Investigative Site ES007
  • Investigative Site ES001
  • Investigative Site ES002
  • Investigative Site ES006
  • Investigative Site ES008
  • Investigative Site ES003
  • Investigative Site ES005

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

INCB054707 Dose A

INCB054707 Dose B

INCB054707 Dose C

Placebo followed by INCB054707 Dose B or C

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Proportion of participants achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score
Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".

Secondary Outcome Measures

Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS)
Defined as IGA score of 0 or 1 with a ≥ 2-grade improvement from baseline
Time to ≥ 4-point improvement from baseline in Itch NRS score
Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.

Full Information

First Posted
September 20, 2021
Last Updated
September 26, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05061693
Brief Title
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
April 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prurigo Nodularis
Keywords
Prurigo nodularis, PN, INCB054707, chronic pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INCB054707 Dose A
Arm Type
Experimental
Arm Description
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).
Arm Title
INCB054707 Dose B
Arm Type
Experimental
Arm Description
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).
Arm Title
INCB054707 Dose C
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo followed by INCB054707 Dose B or C
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
INCB054707
Other Intervention Name(s)
Povorcitinib
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral; Tablet
Primary Outcome Measure Information:
Title
Proportion of participants achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score
Description
Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS)
Description
Defined as IGA score of 0 or 1 with a ≥ 2-grade improvement from baseline
Time Frame
Week 16
Title
Time to ≥ 4-point improvement from baseline in Itch NRS score
Description
Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline
Time Frame
Up to Week 48
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Butler, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site US010
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Investigative Site US024
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Investigative Site US001
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Investigative Site US014
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Investigative Site US019
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Investigative Site US016
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Investigative Site US013
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Investigative Site US009
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-2231
Country
United States
Facility Name
Investigative Site 1071320
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Investigative Site US008
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Investigative Site US011
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Investigative Site US003
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Investigative Site US017
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Investigative Site US006
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Investigative Site US004
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Investigative Site US023
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Investigative Site US002
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Investigative Site US012
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Investigative Site US022
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Investigative Site US021
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Investigative Site US005
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Investigative Site US018
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigative Site US007
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Investigative Site CA002
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
Investigative Site CA001
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Investigative Site CA004
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R9
Country
Canada
Facility Name
Investigative Site CA003
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Investigative Site DE007
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Investigative Site DE005
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigative Site DE004
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Investigative Site DE003
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Investigative Site DE001
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Investigative Site DE002
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Investigative Site DE008
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Investigative Site PL005
City
Kielce
ZIP/Postal Code
253016
Country
Poland
Facility Name
Investigative Site PL003
City
Osielsko
ZIP/Postal Code
86-031
Country
Poland
Facility Name
Investigative Site PL001
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Investigative Site PL004
City
Torun
ZIP/Postal Code
87100
Country
Poland
Facility Name
Investigative Site PL002
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Investigative Site PR002
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Facility Name
Investigative Site PR001
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Investigative Site ES004
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Investigative Site ES007
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Investigative Site ES001
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigative Site ES002
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Investigative Site ES006
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Investigative Site ES008
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Investigative Site ES003
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Investigative Site ES005
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing 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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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