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A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

NCT04905212 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-12-06

No results posted yet for this study

Summary

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

Conditions

Interventions

DRUG

Telitacicept 160mg

Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.

DRUG

Telitacicept 240mg

Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.

DRUG

Placebo

Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2023-11-09
Completion
2023-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04905212 on ClinicalTrials.gov