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Axial SpondyloarthritisPhase 2NCT05162937

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

A Phase 2 study testing IL-17A antibody in people with Axial Spondyloarthritis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
IL-17A antibody
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteChina
Study dates
7 Sep 2020to 2 Nov 2021
Phase
Phase 2
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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

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

Read the 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.

Being tested
IL-17A antibody
Keywords
IL-17A, Axial Spondyloarthritis
Medical subject headings
Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IL-17A antibodyBiological

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

Study groups in NCT05162937
Study groupRoleWhat they receive
Treatment group 1ExperimentalDrug：GR1501 100mg
Receives: Biological: IL-17A antibody
Treatment group 2ExperimentalDrug：GR1501 200mg
Receives: Biological: IL-17A antibody
Treatment group 3ExperimentalDrug：GR1501 300mg
Receives: Biological: IL-17A antibody
Treatment group 4Placebo comparatorDrug：placebo
Receives: Biological: IL-17A antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 16

Secondary outcomes (6)

  1. ASAS 40 responder

    Number of Participants Who Achieved ASAS40，ASAS40 responder had improvement of 40% or more and absolute improvement of at least 2 units (scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration 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)

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

  2. ASAS 5/6 responder

    Number of Participants Who Achieved ASAS5/6，ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: 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); Spinal Mobility (BASFI); Acute phase reactant (CRP)

    Measured: Week 12, 16, 24

  3. Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score

    BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement

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

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

    The BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain / swelling, areas of localized tenderness (called enthesitis, or inflammation of insertion sites of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The physician will globally assess the subject's current disease state

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

  5. Magnetic Resonance Imaging (MRI) Inflammatory Scores

    The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of ASspiMRI-a (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema (less than25% of DVU; 3=severe bone marrow edema (more that 50% of DVU). The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation

    Measured: Week 16, 24

  6. Number of adverse events to measure Safety of subcutaneously administered GR1501

    Safety of GR1501 s.c. injection will be documented as numbers of adverse event

    Measured: to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start7 Sep 2020
  3. Primary completion30 Jul 2021
  4. Study completion2 Nov 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162937
Sponsor's protocol ID
GR1501-002
Status last verified
Apr 2023
First submitted
17 Sep 2021
Last updated
5 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: within six months after the trail complete

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IL-17A antibody 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 2 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 5 Apr 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

ASAS 20 responder (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 NCT05162937.

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 5 Apr 2023.

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