Axial SpondyloarthritisPhase 3NCT05881785
Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
A Phase 3 study testing GR1501 low dose and GR1501 high dose in people with Axial Spondyloarthritis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- GR1501 low dose and GR1501 high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 465 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2022to 21 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Total ankylosis of the spine
- Ongoing or serious infection
- Either a current diagnosis or a recent history of malignant disease
- Are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
Peking union Medical Hosipital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
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.
Read the detailed description
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.
- Conditions
- Axial Spondyloarthritis
- Being tested
- GR1501 low dose, GR1501 high dose, placebo
- Keywords
- IL-17A, Autoimmune disease
- Medical subject headings
- Axial Spondyloarthritis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR1501 low doseBiological
3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly
GR1501 high doseBiological
3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly
placeboBiological
- Core treatment period:placebo
- Maintenance treatment period: GR1501 injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | GR1501 low dose Receives: Biological: GR1501 low dose |
| Treatment group 2 | Experimental | GR1501 high dose Receives: Biological: GR1501 high dose |
| treatment group 3 | Placebo comparator | placebo Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 16
Secondary outcomes (8)
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
Measured: week 2 to 48
The Proportion of Participants Who Achieve an ASAS 40 Response
ASAS40 response is defined as an improvement of ≥40% and ≥2 units in at least three of the four ASAS main domains
Measured: 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
Measured: week 16，32，48
Change From Baseline in Mobility on the BASMI
5 clinical measurements Bath Ankylosing Spondylitis Metrology Index
Measured: week 16，32，48
Change From Baseline in BASDAI Response
6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis
Measured: 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
Measured: 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
Measured: 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
Measured: week 16，32，48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start13 Jun 2022
- Primary completion18 Dec 2023
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xiaofeng zeng, PHD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881785
- Sponsor's protocol ID
- GR1501-007
- Status last verified
- Sep 2024
- First submitted
- 21 May 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41247398
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT05881785
- Acronym / sponsor ID
- GR1501-007
- Conditions
- Axial Spondyloarthritis
- Keywords
- IL-17A, Autoimmune disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Biological: GR1501 low doseGR1501 low dose |
| Treatment group 2 | Experimental | Biological: GR1501 high doseGR1501 high dose |
| treatment group 3 | Placebo comparator | Biological: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Total ankylosis of the spine
- Ongoing or serious infection
- Either a current diagnosis or a recent history of malignant disease
- Are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GR1501 low dose3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly | Biological | Treatment group 1 |
| GR1501 high dose3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly | Biological | Treatment group 2 |
| placebo* Core treatment period:placebo * Maintenance treatment period: GR1501 injection | Biological | treatment group 3 |
Primary outcome
The Proportion of Participants Who Achieve an ASAS 20 Response
Time frame: week 16
ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains
8 secondary outcomes
The Proportion of Participants Who Achieve an ASAS 20 Response
Time frame: week 2 to 48
The Proportion of Participants Who Achieve an ASAS 40 Response
Time frame: week 2 to 48
The Proportion of Participants Who Achieve an ASAS 5/6 Response
Time frame: week 16，32，48
Change From Baseline in Mobility on the BASMI
Time frame: week 16，32，48
Change From Baseline in BASDAI Response
Time frame: week 16，32，48
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: week 16，32，48
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time frame: week 16，32，48
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: week 16，32，48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 41247398Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaofeng zeng, PHD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GR1501 low dose and GR1501 high dose in people with Axial Spondyloarthritis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Participants Who Achieve an ASAS 20 Response (time frame: week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05881785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.