INCB-54707-306_prurigo nodularis
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis.
IRAS ID
1010327
Contact name
Habib Zalila
Contact email
Sponsor organisation
Incyte Corporation
Clinicaltrials.gov Identifier
Research summary
Prurigo Nodularis (PN) is a chronic skin condition characterised by the presence of hard, extremely itchy bumps known as nodules, which are the result of persistent, intense scratching and rubbing of the skin. PN has a substantial negative impact on quality of life for sufferers and is associated with sleep disturbance, impact on job performance and avoidance of social activities.
The overall goal of treatment for PN is to stop the itch-scratch cycle and reduce itching associated with the condition. This is to allow flattening of the skin nodules/lesions. This Study is being conducted to learn about the safety and effectiveness of a potential new once daily oral treatment for PN. The treatment is called povorcitinib. The study will take place in many countries across the world and about 330 people will participate overall. The study will be separated into 3 'periods':
A 28 day screening period
A treatment period split into a 24 week period where participants will receive either povorcitinib or placebo (placebo-controlled treatment period) and a further 24 week period where participants will all receive povorcitinib (extension treatment period)
A 30 day safety follow up period
Participants will attend about 15 study site visits, 2 phone calls and 2 video calls.
Study procedures will include: Blood and urine tests, ECGs, vital signs, height and weight recording, physical examinations and diary and questionnaire completion.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0179
Date of REC Opinion
21 Oct 2024
REC opinion
Further Information Favourable Opinion