A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
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
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
- 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
- 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
- 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
- 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
Inclusion Criteria:
-
Clinical diagnosis of PN for at least 3 months before screening.
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Inadequate response or intolerant to ongoing or prior PN therapy.
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≥ 20 nodules on ≥ 2 different body regions at screening and Day 1.
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Willingness to avoid pregnancy or fathering children
-
Further inclusion criteria apply.
Exclusion Criteria:
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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.
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Women who are pregnant (or who are considering pregnancy) or lactating.
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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.
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Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
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Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
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Laboratory values outside of the protocol-defined ranges.
-
Further exclusion criteria apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- INCB 54707-206