Prurigo Nodularis MedDRA version: 20.0 Level: LLT Classification code 10037084 Term: Prurigo nodularis System Organ Class: 100000004858
Conditions
Interventions
Product Name: INCB054707
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: N/A
Other descriptive name: INCB054707
Concentration unit: mg milligram(s)
Concentra
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the efficacy of INCB054707 in Prurigo nodularis.;Secondary Objective: - To further assess the treatment effects of INCB054707. - To evaluate the safety and tolerability of INCB054707.;Primary end point(s): Proportion of participants achieving = 4-point improvement in Itch NRS score at Week 16.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of participants achieving IGA-TS (IGA score of 0 or 1 with a = 2-grade improvement from baseline) at Week 16. • Time to = 4-point improvement from baseline in Itch NRS score. • The type, frequency, and severity of AEs, including the results of physical examinations, and evaluation of vital signs, ECGs, and laboratory data.;Timepoint(s) of evaluation of this end point: Week 16 and throughout the study | — |
Countries
Canada, Germany, Poland, Spain, United States
Contacts
Public ContactClinical Trials Information
Incyte Corporation
Outcome results
None listed