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

Sponsor
Incyte Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05061693
Collaborator
(none)
140
Enrollment
49
Locations
4
Arms
23.9
Anticipated Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 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 :
Nov 4, 2021
Anticipated Primary Completion Date :
Apr 20, 2023
Anticipated Study Completion Date :
Nov 2, 2023

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score [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) [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 [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) [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigative Site US010 Phoenix Arizona United States 85006
2 Investigative Site US001 Fountain Valley California United States 92708
3 Investigative Site US014 Sacramento California United States 95816
4 Investigative Site US019 Fort Lauderdale Florida United States 33308
5 Investigative Site US016 Miami Florida United States 33175
6 Investigative Site US013 Miramar Florida United States 33027
7 Investigative Site US009 Tampa Florida United States 33614
8 Investigative Site US008 Plainfield Indiana United States 46168
9 Investigative Site US011 South Bend Indiana United States 46617
10 Investigative Site US003 Baltimore Maryland United States 21287
11 Investigative Site US015 Boston Massachusetts United States 02114
12 Investigative Site US017 Troy Michigan United States 48084
13 Investigative Site US006 Saint Joseph Missouri United States 64506
14 Investigative Site US004 Portsmouth New Hampshire United States 03801
15 Investigative Site US023 Athens Ohio United States 45701
16 Investigative Site US012 Columbus Ohio United States 43230
17 Investigative Site US002 Dublin Ohio United States 43016
18 Investigative Site US022 Murfreesboro Tennessee United States 37130
19 Investigative Site US021 Arlington Texas United States 76011
20 Investigative Site US005 Austin Texas United States 78745
21 Investigative Site US018 Dallas Texas United States 75231
22 Investigative Site US007 Houston Texas United States 77004
23 Investigative Site CA001 Surrey British Columbia Canada V3R 6A7
24 Investigative Site CA004 London Ontario Canada N6A 5R9
25 Investigative Site CA002 Edmonton Canada T6G1C3
26 Investigative Site CA003 Quebec Canada G1W4R4
27 Investigative Site DE006 Bad Bentheim Germany 48455
28 Investigative Site DE005 Berlin Germany 10117
29 Investigative Site DE004 Bonn Germany 53127
30 Investigative Site DE003 Frankfurt Am Main Germany 60590
31 Investigative Site DE001 Hamburg Germany 20246
32 Investigative Site DE002 Muenster Germany 48149
33 Investigative Site DE008 Tubingen Germany 72076
34 Investigative Site PL005 Kielce Poland 253016
35 Investigative Site PL003 Osielsko Poland 86-031
36 Investigative Site PL001 Rzeszow Poland 35-055
37 Investigative Site PL004 Torun Poland 87100
38 Investigative Site PL006 Warsaw Poland 02-758
39 Investigative Site PL002 Wroclaw Poland 50-566
40 Investigative Site PR002 Caguas Puerto Rico 00727
41 Investigative Site PR001 San Juan Puerto Rico 00917
42 Investigative Site ES004 Alicante Spain 03010
43 Investigative Site ES007 Badalona Spain 08916
44 Investigative Site ES001 Barcelona Spain 08036
45 Investigative Site ES002 Cordoba Spain 14004
46 Investigative Site ES006 Granada Spain 18014
47 Investigative Site ES008 Madrid Spain 28041
48 Investigative Site ES003 Madrid Spain 28223
49 Investigative Site ES005 Valencia Spain 46026

Sponsors and Collaborators

  • Incyte Corporation

Investigators

  • Study Director: Kathleen Butler, MD, Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT05061693
Other Study ID Numbers:
  • INCB 54707-206
First Posted:
Sep 29, 2021
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Prurigo
Neurodermatitis

Study Results

No Results Posted as of Jul 27, 2022