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

Completed · Phase 2 · Has a placebo group

Conditions studied: Prurigo Nodularis

In brief

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.

Key facts

Study ID

NCT05061693

Run by

Incyte Corporation

People needed

146

Starts

2021-11-04

Expected to finish

2024-02-28

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigative Site US010 — Phoenix, Arizona, United States
• Investigative Site US024 — Phoenix, Arizona, United States
• Investigative Site US001 — Fountain Valley, California, United States
• Investigative Site US014 — Sacramento, California, United States
• Investigative Site US019 — Fort Lauderdale, Florida, United States
• Investigative Site US016 — Miami, Florida, United States
• Investigative Site US013 — Miramar, Florida, United States
• Investigative Site US009 — Tampa, Florida, United States
• Investigative Site 1071320 — Newnan, Georgia, United States
• Investigative Site US008 — Plainfield, Indiana, United States
• Investigative Site US011 — South Bend, Indiana, United States
• Investigative Site US003 — Baltimore, Maryland, United States
• Investigative Site US017 — Troy, Michigan, United States
• Investigative Site US006 — Saint Joseph, Missouri, United States
• Investigative Site US004 — Portsmouth, New Hampshire, United States
• Investigative Site US023 — Athens, Ohio, United States
• Investigative Site US002 — Dublin, Ohio, United States
• Investigative Site US012 — Gahanna, Ohio, United States
• Investigative Site US022 — Murfreesboro, Tennessee, United States
• Investigative Site US021 — Arlington, Texas, United States
• Investigative Site US005 — Austin, Texas, United States
• Investigative Site US018 — Dallas, Texas, United States
• Investigative Site US007 — Houston, Texas, United States
• Investigative Site CA002 — Edmonton, Alberta, Canada
• Investigative Site CA001 — Surrey, British Columbia, Canada

Full record on ClinicalTrials.gov

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