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

NCT05162937 | Completed Phase 2

• 1 other identifier: GR1501-002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Axial Spondyloarthritis

Keywords

IL-17A; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• ASAS 20 responder

  clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 \[least\] to 10 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores

  Week 16

Secondary Outcomes (6)

• ASAS 40 responder

  Week 2, 4, 8, 12, 16, 20, 24

• ASAS 5/6 responder

  Week 12, 16, 24

• Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score

  Week 2, 4, 8, 12, 16, 20, 24

• 17. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Week 2, 4, 8, 12, 16, 20, 24

• Magnetic Resonance Imaging (MRI) Inflammatory Scores

  Week 16, 24

Other Outcomes (2)

• ADA

  Week 0, 2, 4, 16, 24

• IL-17A

  Week 0, 4, 16

Study Arms (4)

Treatment group 1

EXPERIMENTAL

Drug：GR1501 100mg

Biological: IL-17A antibody

Treatment group 2

EXPERIMENTAL

Drug：GR1501 200mg

Biological: IL-17A antibody

Treatment group 3

EXPERIMENTAL

Drug：GR1501 300mg

Biological: IL-17A antibody

Treatment group 4

PLACEBO COMPARATOR

Drug：placebo

Biological: IL-17A antibody

Interventions

IL-17A antibody BIOLOGICAL

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

Treatment group 1; Treatment group 2; Treatment group 3; Treatment group 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• According with the diagnosis of axial spondyloarthritis (axSpA) by the Assessment of Spondyloarthritis International Society (ASAS);,
• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Xiaofeng Zeng, PHD

  chairman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: December 20, 2021
• Study Start: September 7, 2020
• Primary Completion: July 30, 2021
• Study Completion: November 2, 2021
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)