NCT04643067

Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE

A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Kangpu Biopharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study Title A phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability, pharmacokinetics and preliminary efficacy of KPG-818 in patients with mild to moderate systemic lupus erythematosus

Detailed description

This is a Phase 1b/2a multicenter study to evaluate the safety, PK, PD, and clinical efficacy of KPG-818 in patients with SLE. The trial will consist of 2 parts: Phase 1b, a multiple-ascending dose (MAD) study; and Phase 2a, a proof of concept (POC) study.

Conditions

• SLE; Drug

Interventions

Type	Name	Description
DRUG	KPG-818 low dose	The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.
DRUG	KPG-818 mid dose	The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.
DRUG	KPG-818 high dose	The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.
DRUG	Placebo	This is the comparative arm.

Timeline

• Start date: 2021-06-03
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2020-11-24
• Last updated: 2024-05-23

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study