Clinical trial NCT05162937: to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Preliminary Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR1501 Injection by in Patients With Active Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Axial Spondyloarthritis
Keywords: IL-17A
Axial Spondyloarthritis
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 160 patients were enrolled in the planned trial, and after passing the screening period of 2 weeks, they were randomly assigned to the 100mg group, 200mg group, 300mg group or placebo group according to 1:1:1:1. After the completion of the 16-week administration period, the follow-up period (\~24 weeks) was initiated.
Primary purpose: TREATMENT

Brief 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

Detailed description: This is a randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy, safety, pharmacokinetic, and immunogenicity of GR1501 injection (IL-17A antiboby) at different doses and dosing frequency in patients with active axial spinal arthritis.

A total of 160 patients were enrolled in the planned trial, and after passing the screening period of 2 weeks, they were randomly assigned to the 100mg group, 200mg group, 300mg group or placebo group according to 1:1:1:1.After the completion of the 16-week administration period, the follow-up period (\~24 weeks) was initiated.

Eligibility criteria: Inclusion Criteria:

1. According with the diagnosis of axial spondyloarthritis (axSpA) by the Assessment of Spondyloarthritis International Society (ASAS);,
2. During the screening period, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 points and the Spinal Pain (BASDAI Article 2) NRS score ≥ 4 points;

Exclusion Criteria:

1. Previous or current Crohn's disease;
2. Suffering from ulcerative enteritis and requiring immunosuppressive therapy at present;

Primary outcomes:
measure: ASAS 20 responder
timeFrame: Week 16
Secondary outcomes:
measure: ASAS 40 responder
timeFrame: Week 2, 4, 8, 12, 16, 20, 24
measure: ASAS 5/6 responder
timeFrame: Week 12, 16, 24
measure: Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score
timeFrame: Week 2, 4, 8, 12, 16, 20, 24
measure: 17. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Week 2, 4, 8, 12, 16, 20, 24
measure: Magnetic Resonance Imaging (MRI) Inflammatory Scores
timeFrame: Week 16, 24
measure: Number of adverse events to measure Safety of subcutaneously administered GR1501
timeFrame: to Week 24
Other outcomes:
measure: ADA
timeFrame: Week 0, 2, 4, 16, 24
measure: IL-17A
timeFrame: Week 0, 4, 16
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: chairman
name: Xiaofeng Zeng, PHD
role: PRINCIPAL_INVESTIGATOR
References: