A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

Incyte Corporation0 个研究点目标入组 140 人开始时间: 2021年12月22日最近更新: 2022年5月9日

适应症

试验速览

暂无简介。

•1. Ability to comprehend and willingness to sign a written ICF for the study.
•2. Men and women 18 to 75 years of age.
•3. Clinical diagnosis of PN for at least 3 months before screening.
•4. Inadequate response or intolerant to ongoing or prior PN therapy.
•5. = 20 nodules at screening and Day 1.
•6. Nodules on = 2 different body regions at screening and Day 1.
•7. IGA score = 3 at screening and Day 1.
•8. Pruritus as defined by the following: a. Screening: Itch NRS score = 5 based on recall for the week preceding screening. b. Day 1: Average Itch NRS = 5 for the week before Day 1.
•9. Willingness to avoid pregnancy or fathering children.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 98
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 42

•1. Have chronic pruritus due to a condition other than PN (eg, such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, excoriation syndrome, cholestatic liver disease, chronic kidney disease).
•2. Have neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
•3. Current use of a medication known to cause pruritus.
•4. Current use of anticoagulants or medications known to cause thrombocytopenia.
•5. Received a live vaccine within 6 weeks before the Day 1 visit.
•6. Received dupilumab within 8 weeks before the Day 1 visit.
•7. Prior treatment with a JAK inhibitor.
•8. Planning to receive a live vaccine during the course of the study or within 6 weeks after
•the last dose of study drug.
•9. Uncontrolled thyroid function at screening as determined by the investigator.
•For a full list of Exclusion criteria please refer to the Protocol

发起方