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A Phase 2 Study of Hemay007 in Patients With Rheumatoid Arthritis

NCT05247216 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-03-01

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of Hemay007 in Patients with moderate to severe Rheumatoid Arthritis who are on a stable dose of DMARDs.

Conditions

Interventions

DRUG

Hemay007 800 mg QD group

daily oral administrtion of Hemay007 800 mg QD for 12 weeks, 4 tablets of 200mg Hemay007 and 2 tablets of placebo.

DRUG

Hemay007 1200 mg QD group

daily oral administrtion of Hemay007 1200 mg QD for 12 weeks, 6 tablets of 200mg Hemay007.

DRUG

Hemay007 600 mg QD group

daily oral administrtion of Hemay007 600 mg QD for 12 weeks, 3 tablets of 200mg Hemay007 and 3 tablets of placebo.

DRUG

Hemay007 placebo group

daily oral administrtion of placebo for 12 weeks 6 tablets of placebo.

Sponsors & Collaborators

  • Tianjin Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Juan Li, M.D. · Southern Hospital of Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05247216 on ClinicalTrials.gov