A Phase 2a/b Study of KPL-716 in Prurigo Nodularis
Research type
Research Study
Full title
A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis
IRAS ID
292569
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Kiniksa Pharmaceuticals, Ltd.
Eudract number
2020-004198-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Kiniksa Pharmaceuticals, Ltd., the sponsor, is developing an investigational drug called KPL-716 for the treatment of chronic pruritic (itchy) diseases, including prurigo nodularis (PN): “investigational” means the drug is not approved by the UK Medicines and Healthcare Regulatory Agency (MHRA) for public use yet.
KPL-716 may reduce itching and/or promote healing. KPL-716 is a monoclonal antibody. Antibodies in general are a type of protein that the body makes (a natural process) to block bacteria or viruses and prevent them from causing a disease. KPL-716 is an artificial (not natural) antibody, which is similar to the antibodies that the body makes, but it was specifically made to block a particular protein in the body which may be involved in causing the symptoms and signs of PN. KPL-716 may stop the itching, inflammation, skin thickening and/or fibrosis (scarring) caused by PN.This study is being done to learn if KPL-716 is an effective and safe treatment for participants with PN experiencing severe itching. This is a randomised, double blind, placebo-controlled study. Participants will be randomly assigned into 1 of 4 groups over 16 weeks, with the option to continue an Open Label Extension Period for 36 weeks.
PN is a debilitating disease in which patients suffer from intractable pruritus and disfiguring skin nodules for which there are no approved therapies.The main purpose of this study is to see if taking KPL716 is effective in relieving itch. The study will also assess whether KPL-716 is effective in reducing lumps, improving sleep and quality of life or whether it can promote healing of the skin. This study will compare KPL-716 to a placebo (a liquid that looks like the study drug but has no medication in it).
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0152
Date of REC Opinion
25 Aug 2021
REC opinion
Further Information Favourable Opinion