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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.
This is a randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of GR1501 injection in Radiographic Axial Spondyloarthritis, as well as a confirmatory clinical trial of immunogenicity.
This clinical trial was divided into four stages, namely screening period (W-4~W0), core treatment period (W0~W16), maintenance treatment period (W16~W32), and follow-up period (W32~W48).
target population： radiographic axial spondyloarthritis who had a inadequate response to NSAIDs or have a history of intolerance to NSAIDs.
primary outcome measure:percentage of participants achieving an ASAS20 response in week 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental | GR1501 low dose |
|
| Treatment group 2 | Experimental | GR1501 high dose |
|
| treatment group 3 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR1501 low dose | Biological | 3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 2 to 48 |
| The Proportion of Participants Who Achieve an ASAS 40 Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| xiaofeng zeng, PHD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking union Medical Hosipital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41247398 | Derived | 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. |
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| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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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.
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Double blind
| GR1501 high dose | Biological | 3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly |
|
| placebo | Biological |
|
|
ASAS40 response is defined as an improvement of ≥40% and ≥2 units in at least three of the four ASAS main domains |
| week 2 to 48 |
| The Proportion of Participants Who Achieve an ASAS 5/6 Response | The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains | week 16，32，48 |
| Change From Baseline in Mobility on the BASMI | 5 clinical measurements Bath Ankylosing Spondylitis Metrology Index | week 16，32，48 |
| Change From Baseline in BASDAI Response | 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis | week 16，32，48 |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) | 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities | week 16，32，48 |
| Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) | The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity | week 16，32，48 |
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) | ASDAS is a composite index to assess disease activity in AS | week 16，32，48 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D007154 | Immune System Diseases |