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Phase II Study of Hemay005 in Patients With Active Ankylosing Spondylitis

NCT05407246 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-01-11

No results posted yet for this study

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study. The study was divided into three stages, including screening period(4-week), treatment period(16-week) and observation period. All subjects need to enter a 28 day (4-week) observation period after stopping hemay005 treatment.

Main purpose:

The efficacy of hemay005 tablet in the treatment of active ankylosing spondylitis (as) was evaluated by placebo parallel control.

Secondary purpose:

* To evaluate the safety of oral hemay005 tablets in patients with active as.
* To evaluate the population pharmacokinetics of hemay005 tablets in patients with active as.

Conditions

  • Active Ankylosing Spondylitis

Interventions

DRUG

Hemay005

Hemay005 60 mg treatment group (group A): hemay005 tablets 60 mg bid were used during the treatment period; Hemay005 75 mg treatment group (group B): hemay005 75 mg bid was used during the treatment period; Placebo group (Group C): placebo (hemay005 tablet simulant) bid was used during the treatment period;

Sponsors & Collaborators

  • Tianjin Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaofeng Zeng, M.D · Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2023-08-18
Completion
2023-08-18

Countries

  • China

Study Locations

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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 NCT05407246 on ClinicalTrials.gov