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Ankylosing SpondylitisPhase 2/3NCT04481139

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis

A Phase 2/3 study testing SHR0302 in people with Ankylosing Spondylitis, run by Jiangsu HengRui Medicine 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

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active ankylosing spondylitis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
SHR0302
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
504 participants
Where
1 siteChina
Study dates
14 Oct 2020to 12 May 2023
Phase
Phase 2/3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide signed informed consent.
  • AS diagnosis consistent with the Modified New York Criteria for AS (1984);
  • Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
  • Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
  • If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
  • BMI ≥18 kg/m2

Who cannot join

  • Pregnant women or refuse to receive contraception during the study.
  • Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
  • History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
  • Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 6 months of randomization.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhanguo Li

    Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active ankylosing spondylitis.

Being tested
SHR0302, SHR0302 placebo
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • SHR0302Drug

    SHR0302, oral, once daily

  • SHR0302 placeboDrug

    SHR0302 placebo, oral, once daily

Study groups in NCT04481139
Study groupRoleWhat they receive
SHR0302 dose1ExperimentalSHR0302 dose1 for 24 weeks
Receives: Drug: SHR0302
SHR0302 dose2ExperimentalSHR0302 dose2 for 24 weeks
Receives: Drug: SHR0302
SHR0302 dose3ExperimentalSHR0302 dose3 for 24 weeks
Receives: Drug: SHR0302
PlaceboPlacebo comparatorPlacebo for 12 weeks
Receives: Drug: SHR0302 placebo

What is being measured

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

  1. Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12.

    ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])

    Measured: Week 12

Secondary outcomes (8)

  1. Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 24.

    ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10]) at Week 24.

    Measured: Week 24

  2. Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 12 and Week 24.

    ASAS40 is defined as a >= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.

    Measured: Week 12 and Week 24

  3. Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 5/6 response at Week 12 and Week 24.

    ASAS5/6 is defined as an improvement of at least 20 % in at least five of these six domains (patient global, pain, function, inflammation, CRP, and spinal mobility).

    Measured: Week 12 and Week 24

  4. Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    BASDAI is a commonly used measure to define disease activity levels in axSpA patients. It consists of 6 questions on a 0 through 10 numeric rating scale (NRS) (0 being no problem and 10 being the worst problem) pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain/swelling, Areas of localized tenderness, Morning stiffness duration, and Morning stiffness severity.

    Measured: Week 12 and Week 24

  5. Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24.

    The BASFI is a validated patient reported outcome (PRO) instrument for use in the AS patient population. It consists of 10 items measured on a 0 to 10 NRS, which assesses the ability to perform activities known to be problematic to AS patients such as dressing, bending, reaching, turning, and climbing steps. The total scores range from 0 to 10.

    Measured: Week 12 and Week 24

  6. Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24.

    The BASMI will be conducted at the visits specified to evaluate spinal mobility in a participan.

    Measured: Week 12 and Week 24

  7. Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24.

    SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.

    Measured: Week 12 and Week 24

  8. Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24.

    The ASQoL is an 18-item axSpA-specific Quality of Life (QoL) PRO measure validated in the AS patient population. Concepts measured include activities of daily life, emotional functioning, pain, fatigue, and sleep problems. Each item on ASQoL is given a score of "1" or "0," where a score of "1" is given when an item is affirmed indicating adverse QoL. Total scores can range from 0 (good QoL) to 18 (poor QoL).

    Measured: Week 12 and 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 posted22 Jul 2020
  2. Study start14 Oct 2020
  3. Primary completion15 Nov 2022
  4. Study completion12 May 2023

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04481139
Sponsor's protocol ID
SHR0302-302
Status last verified
Jul 2022
First submitted
15 Jul 2020
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu X, Wei H, Liu L, Yang R, Shi Q, Pang D. Ivarmacitinib improves patient-reported outcomes across multiple domains in patients with active ankylosing spondylitis: a post hoc analysis of a phase II/III trial. Front Pharmacol. 2025 Nov 20;16:1710434. doi: 10.3389/fphar.2025.1710434. eCollection 2025.

    PubMed 41357869

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SHR0302 in people with Ankylosing Spondylitis, run by Jiangsu HengRui Medicine 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 6 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 27 Jul 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 combined 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.

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?

Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12. (time frame: Week 12). 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 NCT04481139, 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 27 Jul 2023.

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