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

NCT04643067 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-05-23

No results posted yet for this study

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

Conditions

  • SLE; Drug

Interventions

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.

Sponsors & Collaborators

  • Kangpu Biopharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • MD · Kangpu Biopharmaceuticals, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2023-08-18
Completion
2023-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643067 on ClinicalTrials.gov