KPL-387

KPL-387 is a protein-based substance developed by Kiniksa Pharmaceuticals Ltd. It is classified as an investigational medicine, meaning it has no marketing authorisation in the product records reviewed.^[1] The substance is being studied in the cardiovascular disease area, specifically for recurrent pericarditis.^[1]

What is KPL-387?

KPL-387 is a protein-based investigational substance. In the registry records, it is listed under the product name KPL-387 and has no other names or trade names.^[1] The substance is not yet authorised as a medicine, so it is available only within clinical trials.^[1] The company responsible for the product is Kiniksa Pharmaceuticals Ltd.^[1]

How does KPL-387 work?

The available registry data do not describe the molecular target or mechanism of action of KPL-387. What is known is that it is a protein-based substance given by injection, and it is being tested in recurrent pericarditis, an inflammatory condition of the sac surrounding the heart.^[1] No supplementary sources were provided to explain the mechanism further.

Which conditions is it used or studied for?

• Recurrent pericarditis — a condition in which the pericardium, the thin sac around the heart, becomes inflamed repeatedly. The trial focuses on patients whose recurrent pericarditis is well controlled on standard therapies and who are being transitioned to KPL-387 alone.^[1]

How is KPL-387 given?

KPL-387 is prepared as a solution for injection and is given by subcutaneous injection, meaning it is injected under the skin.^[1] The registry record lists the dose as 00 mg, which indicates that the dose was not reported in the register; therefore, no specific dose is given here.^[1]

What do the clinical trials show?

The clinical trial data contain two records. One record is a Phase 2 interventional study titled "A Study of Transition Regimens to KPL-387 Monotherapy in Participants with Well-Controlled Recurrent Pericarditis".^[1] This trial has an authorised status and an enrollment of 120 participants.^[1] The second record is ongoing with 125 participants, but it provides no title, condition, phase, or interventions in the data.^[1] Because details are missing for this second record, the rest of this section describes the Phase 2 trial.

What is the trial measuring?

The Phase 2 trial has two primary efficacy endpoints. During the posology period, the main measure is the proportion of participants free from pericarditis recurrence by Week 16, where only recurrences confirmed by a Clinical Endpoint Committee count as events.^[1] During the long-term extension period, the main measure is the annualised rate of pericarditis recurrence, again counting only committee-confirmed events.^[1] The trial aims to characterise the efficacy of dosing regimens used to transition participants from prior pericarditis therapies to KPL-387 monotherapy.^[1]

Who can take part?

The Phase 2 trial enrols participants with well-controlled recurrent pericarditis who are on standard therapies. The study is designed for people whose disease is stable enough to consider moving to KPL-387 alone.^[1] The registry record does not list detailed inclusion or exclusion criteria.

What side effects are known?

No side effect data were provided in the clinical trial records or supplementary sources. Therefore, this section is omitted.