A clinical trial to assess a new drug (KPL-716) for prurigo nodularis (PN).
About this study
Prurigo nodularis (PN) is a chronic skin disease that characterised by hard, intensely itchy (pruritus) lumps that form on the skin. Currently there are no approved therapies to treat PN.
KPL-716 is a drug made up of a protein known as an antibody. Antibodies are usually produced by special immune cells to fight infections (bacteria, viruses or other intruders into the body). The antibody KPL-716 works by inhibiting certain inflammatory mediators and pathways involved in inflammation and pruritus.
The aim of the Kiniksa study is to assess the safety, efficacy and tolerability of the new drug in reducing pruritus in people with PN.
Anticipated enrolment close date: July 2022
Who can take part
Inclusion criteria
- 18 years of age or older
- Have a diagnosis of PN
- Have at least 20 nodules
Exclusion criteria
- No previous biologic therapy in past 3 months
- Presence of scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis or any skin condition other than PN
- Presence or history of cancer 5 years prior with the exception of basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix successfully treated.
- Presence of uncontrolled hyperthyroidism or hypothyroidism or uncontrolled diabetes
- Has had a severe allergic reaction to any foods or medications including anaphylactic reactions
What's involved
- Total of 52 weeks involved in the study
- An injection every 4 weeks
- Blood tests
- Electrocardiogram (ECG)
- Vital signs
- Photographs of affected areas
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
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The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.