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to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis

NCT05162937 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-04-05

No results posted yet for this study

Summary

Dosage: 100mg or 200mg or 300mg Administration frequency: Q2W administration in the first 4 weeks (W0, W2, W4), and subsequent Q4W administration (W8, W12) Administration: subcutaneous injection Specifications: 100mg/ 1mL/bottle or placebo 0mg/1ml/ bottle

Conditions

  • Axial Spondyloarthritis

Interventions

BIOLOGICAL

IL-17A antibody

Recombinant fully human IgG4 anti-IL-17A monoclonal antibody drug

Sponsors & Collaborators

  • Genrix (Shanghai) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaofeng Zeng, PHD · chairman

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2021-07-30
Completion
2021-11-02

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 NCT05162937 on ClinicalTrials.gov