NCT05247216

A Phase 2 Study of Hemay007 in Patients With Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Hemay007 in Patients With Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study adopts a multi-center, randomized, double-blind clinical study design. Patients with moderate to severe active rheumatoid arthritis who meet the inclusion criteria but do not meet the exclusion criteria will be randomly assigned into the 600 mg QD group, 800 mg QD group, 1200 mg QD group and placebo group at a ratio of 1:1:1:1, with about 35 subjects in each group. Patients in all the groups will be treated with Hemay007 or placebo for 12 weeks, and observed for 4 weeks after the treatment. This study is 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

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-26
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2022-02-18
• Last updated: 2024-03-01

Locations

41 sites across 1 country: China