Prurigo Nodularis Clinical Trial
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
Verified date | May 2024 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 146 |
Est. completion date | February 28, 2024 |
Est. primary completion date | August 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Investigative Site CA002 | Edmonton | Alberta |
Canada | Investigative Site CA004 | London | Ontario |
Canada | Investigative Site CA003 | Quebec | |
Canada | Investigative Site CA001 | Surrey | British Columbia |
Germany | Investigative Site DE007 | Bad Bentheim | |
Germany | Investigative Site DE005 | Berlin | |
Germany | Investigative Site DE004 | Bonn | |
Germany | Investigative Site DE003 | Frankfurt Am Main | |
Germany | Investigative Site DE001 | Hamburg | |
Germany | Investigative Site DE002 | Muenster | |
Germany | Investigative Site DE008 | Tubingen | |
Poland | Investigative Site PL005 | Kielce | |
Poland | Investigative Site PL003 | Osielsko | |
Poland | Investigative Site PL001 | Rzeszow | |
Poland | Investigative Site PL004 | Torun | |
Poland | Investigative Site PL002 | Wroclaw | |
Puerto Rico | Investigative Site PR002 | Caguas | |
Puerto Rico | Investigative Site PR001 | San Juan | |
Spain | Investigative Site ES004 | Alicante | |
Spain | Investigative Site ES007 | Badalona | |
Spain | Investigative Site ES001 | Barcelona | |
Spain | Investigative Site ES002 | Cordoba | |
Spain | Investigative Site ES006 | Granada | |
Spain | Investigative Site ES003 | Madrid | |
Spain | Investigative Site ES008 | Madrid | |
Spain | Investigative Site ES005 | Valencia | |
United States | Investigative Site US021 | Arlington | Texas |
United States | Investigative Site US023 | Athens | Ohio |
United States | Investigative Site US005 | Austin | Texas |
United States | Investigative Site US003 | Baltimore | Maryland |
United States | Investigative Site US018 | Dallas | Texas |
United States | Investigative Site US002 | Dublin | Ohio |
United States | Investigative Site US019 | Fort Lauderdale | Florida |
United States | Investigative Site US001 | Fountain Valley | California |
United States | Investigative Site US012 | Gahanna | Ohio |
United States | Investigative Site US007 | Houston | Texas |
United States | Investigative Site US016 | Miami | Florida |
United States | Investigative Site US013 | Miramar | Florida |
United States | Investigative Site US022 | Murfreesboro | Tennessee |
United States | Investigative Site 1071320 | Newnan | Georgia |
United States | Investigative Site US010 | Phoenix | Arizona |
United States | Investigative Site US024 | Phoenix | Arizona |
United States | Investigative Site US008 | Plainfield | Indiana |
United States | Investigative Site US004 | Portsmouth | New Hampshire |
United States | Investigative Site US014 | Sacramento | California |
United States | Investigative Site US006 | Saint Joseph | Missouri |
United States | Investigative Site US011 | South Bend | Indiana |
United States | Investigative Site US009 | Tampa | Florida |
United States | Investigative Site US017 | Troy | Michigan |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States, Canada, Germany, Poland, Puerto Rico, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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". | Week 16 | |
Secondary | 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 | Week 16 | |
Secondary | 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 | Up to Week 48 | |
Secondary | 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. | Up to Week 48 |
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