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History of Changes for Study: NCT05061693
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Latest version (submitted May 13, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 20, 2021 None (earliest Version on record)
2 September 30, 2021 Eligibility and Study Status
3 October 14, 2021 Recruitment Status, Study Status and Contacts/Locations
4 October 25, 2021 Contacts/Locations and Study Status
5 November 2, 2021 Study Status
6 November 22, 2021 Study Status
7 December 14, 2021 Study Status and Contacts/Locations
8 February 23, 2022 Study Status and Contacts/Locations
9 February 25, 2022 Contacts/Locations and Study Status
10 February 28, 2022 Contacts/Locations and Study Status
11 March 8, 2022 Study Status and Contacts/Locations
12 April 6, 2022 Study Status and Contacts/Locations
13 April 19, 2022 Contacts/Locations and Study Status
14 May 25, 2022 Study Status and Contacts/Locations
15 June 27, 2022 Contacts/Locations and Study Status
16 July 25, 2022 Study Status and Contacts/Locations
17 September 7, 2022 Contacts/Locations and Study Status
18 September 14, 2022 Arms and Interventions and Study Status
19 October 17, 2022 Study Status and Contacts/Locations
20 October 25, 2022 Contacts/Locations and Study Status
21 November 7, 2022 Contacts/Locations and Study Status
22 November 15, 2022 Contacts/Locations and Study Status
23 December 1, 2022 Study Status, Contacts/Locations and Eligibility
24 May 30, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
25 September 26, 2023 Study Status and Study Design
26 February 27, 2024 Study Status
27 May 13, 2024 Recruitment Status and Study Status
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Study NCT05061693
Submitted Date:  April 6, 2022 (v12)

Open or close this module Study Identification
Unique Protocol ID: INCB 54707-206
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2022
Overall Status: Recruiting
Study Start: November 4, 2021
Primary Completion: April 20, 2023 [Anticipated]
Study Completion: November 2, 2023 [Anticipated]
First Submitted: September 20, 2021
First Submitted that
Met QC Criteria:
September 20, 2021
First Posted: September 29, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 6, 2022
Last Update Posted: April 8, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Incyte Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Prurigo Nodularis
Keywords: Prurigo nodularis
PN
INCB054707
chronic pruritus
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 140 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
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
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
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 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.
Open or close this module Contacts/Locations
Central Contact Person: Incyte Corporation Call Center (US)
Telephone: 1.855.463.3463
Email: medinfo@incyte.com
Central Contact Backup: Incyte Corporation Call Center (ex-US)
Telephone: +800 00027423
Email: eumedinfo@incyte.com
Locations: United States, Arizona
Investigative Site US010
[Recruiting]
Phoenix, Arizona, United States, 85006
United States, California
Investigative Site US001
[Recruiting]
Fountain Valley, California, United States, 92708
Investigative Site US014
[Not yet recruiting]
Sacramento, California, United States, 95816
United States, Florida
Investigative Site US019
[Recruiting]
Fort Lauderdale, Florida, United States, 33308
Investigative Site US016
[Recruiting]
Miami, Florida, United States, 33175
Investigative Site US013
[Recruiting]
Miramar, Florida, United States, 33027
Investigative Site US009
[Recruiting]
Tampa, Florida, United States, 33614
United States, Indiana
Investigative Site US008
[Recruiting]
Plainfield, Indiana, United States, 46168
Investigative Site US011
[Recruiting]
South Bend, Indiana, United States, 46617
United States, Maryland
Investigative Site US003
[Not yet recruiting]
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Investigative Site US015
[Not yet recruiting]
Boston, Massachusetts, United States, 02114
United States, Michigan
Investigative Site US017
[Recruiting]
Troy, Michigan, United States, 48084
United States, Missouri
Investigative Site US006
[Recruiting]
Saint Joseph, Missouri, United States, 64506
United States, New Hampshire
Investigative Site US004
[Recruiting]
Portsmouth, New Hampshire, United States, 03801
United States, Ohio
Investigative Site US012
[Recruiting]
Columbus, Ohio, United States, 43230
Investigative Site US002
[Recruiting]
Dublin, Ohio, United States, 43016
United States, Tennessee
Investigative Site US022
[Not yet recruiting]
Murfreesboro, Tennessee, United States, 37130
United States, Texas
Investigative Site US021
[Not yet recruiting]
Arlington, Texas, United States, 76011
Investigative Site US005
[Recruiting]
Austin, Texas, United States, 78745
Investigative Site US018
[Recruiting]
Dallas, Texas, United States, 75231
Investigative Site US007
[Recruiting]
Houston, Texas, United States, 77004
Canada
Investigative Site CA002
[Recruiting]
Edmonton, Canada, T6G1C3
Investigative Site CA003
[Recruiting]
Quebec, Canada, G1W4R4
Canada, British Columbia
Investigative Site CA001
[Recruiting]
Surrey, British Columbia, Canada, V3R 6A7
Canada, Ontario
Investigative Site CA004
[Not yet recruiting]
London, Ontario, Canada, N6A 5R9
Germany
Investigative Site DE005
[Not yet recruiting]
Berlin, Germany, 10117
Investigative Site DE004
[Not yet recruiting]
Bonn, Germany, 53127
Investigative Site DE003
[Not yet recruiting]
Frankfurt Am Main, Germany, 60590
Investigative Site DE001
[Not yet recruiting]
Hamburg, Germany, 20246
Investigative Site DE002
[Not yet recruiting]
Muenster, Germany, 48149
Poland
Investigative Site PL005
[Not yet recruiting]
Kielce, Poland, 253016
Investigative Site PL003
[Not yet recruiting]
Osielsko, Poland, 86-031
Investigative Site PL001
[Not yet recruiting]
Rzeszow, Poland, 35-055
Investigative Site PL004
[Not yet recruiting]
Torun, Poland, 87100
Investigative Site PL002
[Not yet recruiting]
Wroclaw, Poland, 50-566
Spain
Investigative Site ES004
[Not yet recruiting]
Alicante, Spain, 03010
Investigative Site ES001
[Not yet recruiting]
Barcelona, Spain, 08036
Investigative Site ES002
[Not yet recruiting]
Cordoba, Spain, 14004
Investigative Site ES006
[Not yet recruiting]
Granada, Spain, 18014
Investigative Site ES003
[Not yet recruiting]
Madrid, Spain, 28223
Investigative Site ES005
[Not yet recruiting]
Valencia, Spain, 46026
Open or close this module IPDSharing
Plan to Share IPD: Yes

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 Information:
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
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services