A study to test the efficacy and safety of the drug INCB054707 on a skin condition called Prurigo Nodularis
- Conditions
- Prurigo NodularisMedDRA version: 20.0Level: LLTClassification code 10037084Term: Prurigo nodularisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2021-006329-23-ES
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 140
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the efficacy of INCB054707 in Prurigo nodularis.;Secondary Objective: - To further assess the treatment effects of INCB054707.<br>- 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 Outcome Measures
Name Time Method 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.<br>• Time to = 4-point improvement from baseline in Itch NRS score.<br>• 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