Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis

NCT05881785 | Completed Phase 3

• 1 other identifier: GR1501-007
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to demonstrate the clinical efficacy of GR1501 at week 16; and to demonstrate safety and tolerability of GR1501 compared to placebo in patients with Radiographic Axial Spondyloarthritis at week 16 and long term safety up to Week 48。 The main question it aims to answer is whether GR1501 injection was superior to placebo in the proportion of subjects with ASAS20 response at week 16 in patients with Radiographic Axial Spondyloarthritis.

Conditions

Axial Spondyloarthritis

Keywords

IL-17A; Autoimmune disease

Outcome Measures

Primary Outcomes (1)

• The Proportion of Participants Who Achieve an ASAS 20 Response

  ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains

  week 16

Secondary Outcomes (8)

• The Proportion of Participants Who Achieve an ASAS 20 Response

  week 2 to 48

• The Proportion of Participants Who Achieve an ASAS 40 Response

  week 2 to 48

• The Proportion of Participants Who Achieve an ASAS 5/6 Response

  week 16，32，48

• Change From Baseline in Mobility on the BASMI

  week 16，32，48

• Change From Baseline in BASDAI Response

  week 16，32，48

Study Arms (3)

Treatment group 1

EXPERIMENTAL

GR1501 low dose

Biological: GR1501 low dose

Treatment group 2

EXPERIMENTAL

GR1501 high dose

Biological: GR1501 high dose

treatment group 3

PLACEBO COMPARATOR

placebo

Biological: placebo

Interventions

GR1501 low dose BIOLOGICAL

3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly

Treatment group 1

GR1501 high dose BIOLOGICAL

3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly

Treatment group 2

placebo BIOLOGICAL

* Core treatment period:placebo * Maintenance treatment period: GR1501 injection

treatment group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
• inadequate response, contraindications or intolerance to NSAIDs

You may not qualify if:

• Total ankylosis of the spine
• Ongoing or serious infection
• Either a current diagnosis or a recent history of malignant disease
• Are pregnant or breastfeeding

Sponsors & Collaborators

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

Study Sites (1)

Peking union Medical Hosipital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Zhang S, Xu D, Liu S, Li S, Wang X, Yuan F, Gou W, Xu B, Sun L, Gu J, Zhou D, Li X, Kong N, Zhao Y, Hao J, Li T, Fan X, Shu Q, Wei H, Jiang T, Yang J, Qian L, Sun H, Cai X, Jiang Z, Yuan G, Qin L, Yang M, Xu J, Fan W, Sun L, Zhang H, Zhang C, Zhang N, Da Z, Hu J, Jin J, Liu J, Dai L, Dong L, Wang W, Zeng X. Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study. BioDrugs. 2026 Jan;40(1):151-162. doi: 10.1007/s40259-025-00750-0. Epub 2025 Nov 17.

  PMID: 41247398 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• xiaofeng zeng, PHD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 465 patients were randomly assigned to 100mg GR1501 injection, 200mg GR1501 injection, and placebo group at 1:1:1. Randomized stratification factors included history of biologic therapy and weight. After the completion of 16-week ,subjects in the GR1501 injection group continued to be administered GR1501 injection, and those in the placebo group were randomly assigned 1:1 to the 100mg GR1501 injection and 200mg GR1501 injection.

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: June 13, 2022
• Primary Completion: December 18, 2023
• Study Completion: May 21, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)