Ankylosing Spondylitis (AS)Phase 4NCT07894497
Ivarmacitinib With or Without Celecoxib for Ankylosing Spondylitis
A Phase 4 study testing Ivarmacitinib with celecoxib and Ivarmacitinib Monotherapy in people with Ankylosing Spondylitis (AS), run by Peking University Third Hospital.
Trial summary
Background: Ankylosing spondylitis (AS) is a chronic, progressive inflammatory disease mainly affecting the spine and sacroiliac joints, causing pain, stiffness, structural damage, and functional disability. NSAIDs remain first-line therapy, while biologics and JAK inhibitors have expanded treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis (AS)
- What is being tested?
- Ivarmacitinib with celecoxib and Ivarmacitinib Monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2026to 31 Jul 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Voluntarily signed informed consent prior to any study-related procedure, able to communicate well with investigators, and willing to comply with all protocol requirements.
- Age ≥18 years at the time of signing informed consent.
- Fulfilment of the 1984 modified New York criteria for ankylosing spondylitis.
- Confirmed active AS at screening and before randomization, defined as BASDAI ≥4 and total back pain VAS ≥4.
- Inadequate response to NSAIDs (defined as inadequate response to ≥2 NSAIDs at recommended doses for a total of ≥4 weeks, with each NSAID administered at the recommended dose for ≥2 weeks), or intolerance/contraindication to NSAIDs.
Who cannot join
- concomitant other active inflammatory diseases or infections; prior treatment with any JAK inhibitor; history of major cardiovascular events, active peptic ulcer or bleeding, or moderate-to-severe renal insufficiency; pregnancy, lactation, or planned pregnancy; significant laboratory abnormalities (white blood cell count <3.0 × 10⁹/L; neutrophil count <1.5 × 10⁹/L; hemoglobin <90 g/L; platelet count <100 × 10⁹/L; transaminases >3 × ULN; eGFR <60 mL/min/1.73 m²; positive HBsAg, anti-HIV, syphilis serology, or anti-HCV); known hypersensitivity to the investigational product, celecoxib or any of their components; malignancy within 5 years prior to screening or current malignancy; severe, progressive, uncontrolled cardiovascular, cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematologic, endocrine, neurologic or psychiatric disease (e.g., depression, suicidal tendency); and any other condition judged by the investigator to compromise the evaluation of safety or efficacy.
About this study
Official title: A Randomized Controlled Study Evaluating the Efficacy and Safety of Ivarmacitinib Combined With Celecoxib Versus Ivarmacitinib Monotherapy in Patients With Ankylosing Spondylitis
Background: Ankylosing spondylitis (AS) is a chronic, progressive inflammatory disease mainly affecting the spine and sacroiliac joints, causing pain, stiffness, structural damage, and functional disability. NSAIDs remain first-line therapy, while biologics and JAK inhibitors have expanded treatment options. However, many patients have inadequate responses or residual symptoms, and long-term combination with NSAIDs is common despite uncertain incremental benefit. Ivarmacitinib is a highly selective oral JAK1 inhibitor that has shown efficacy in active AS. Whether concomitant celecoxib adds benefit to ivarmacitinib monotherapy remains unknown.
Objectives: To compare the efficacy and safety of ivarmacitinib plus celecoxib versus ivarmacitinib monotherapy in patients with active AS. The primary objective is to compare the proportion achieving an ASAS20 response at week 24.
Read more
Methods: This prospective, single-center, randomized, open-label, parallel-group, active-controlled superiority trial will enroll 138 patients with active AS (BASDAI ≥4 and total back pain VAS ≥4) who had inadequate response to at least two NSAIDs or intolerance/contraindication to NSAIDs. Participants will be randomized 1:1 to ivarmacitinib 4 mg once daily plus celecoxib 200 mg twice daily or ivarmacitinib 4 mg once daily for 48 weeks, with as-needed rescue analgesia permitted. The study is open-label, but endpoint assessors and the statistician will be blinded. Key exclusion criteria include prior JAK inhibitor use, major cardiovascular events, active peptic ulcer or bleeding, moderate-to-severe renal insufficiency, pregnancy, significant laboratory abnormalities, and malignancy within 5 years.
Outcomes: The primary endpoint is the proportion achieving ASAS20 at week 24. Secondary endpoints include ASAS20 at weeks 12 and 48; ASAS40 and ASAS5/6; changes in BASDAI, ASDAS-CRP, CRP, ESR, BASMI, BASFI, pain VAS, ASQoL, MASES, GUESS, and SPARCC MRI score; rescue analgesic use; and adverse event incidence, type, severity, and relatedness, with attention to gastrointestinal, cardiovascular, renal, and infectious risks.
Sample Size: Assuming a week-24 ASAS20 rate of 66.7% in the combination group, a 25-percentage-point superiority margin, two-sided α = 0.05, 80% power, and 15% dropout, 69 patients per group are required (total 138).
Statistical Analysis: The full analysis set includes all randomized patients receiving at least one dose, analyzed as randomized. The primary analysis will compare week-24 ASAS20 proportions using a normal-approximation Z-test with 95% CI and p-value; significance is p ≤ 0.025 one-sided. Secondary categorical endpoints will use the Z-test with non-responder imputation; continuous variables will use MMRM or ANCOVA. Safety will be analyzed descriptively in the safety set.
Expected Significance: This trial will provide prospective, head-to-head evidence on whether regular celecoxib adds benefit to ivarmacitinib monotherapy, informing individualized NSAID-JAK inhibitor combination decisions and supporting evidence-based optimization of AS treatment.
- Conditions
- Ankylosing Spondylitis (AS)
- Being tested
- Ivarmacitinib with celecoxib, Ivarmacitinib Monotherapy
- Keywords
- ankylosing spondylitis, ivarmacitinib, celecoxib, combination therapy, ASAS20
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivarmacitinib with celecoxibDrug
Ivarmacitinib Combined with Celecoxib
Ivarmacitinib MonotherapyDrug
Ivarmacitinib
| Study group | Role | What they receive |
|---|---|---|
| Ivarmacitinib with Celecoxib | Experimental | Not described Receives: Drug: Ivarmacitinib with celecoxib |
| Ivarmacitinib | Active comparator | Not described Receives: Drug: Ivarmacitinib Monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving an ASAS20 response at week 24.
Participants achieved an ASAS20 response if they had at least 20% improvement and at least 1-unit absolute improvement in at least 3 of the following 4 domains, with no worsening of at least 20% and at least 1 unit in the remaining domain:
- Patient global assessment of disease activity, measured on a 0-10 visual analog scale (VAS);
- Total back pain, measured on a 0-10 VAS;
- Bath Ankylosing Spondylitis Functional Index (BASFI), scored from 0 to 10;
- Mean of the two morning stiffness items of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), each scored from 0 to 10; Participants who did not meet the ASAS20 criteria, or for whom week-24 data were missing, were counted as non-responders.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894497
- Sponsor's protocol ID
- M20260856
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Evaluating the Efficacy and Safety of Ivarmacitinib Combined With Celecoxib Versus Ivarmacitinib Monotherapy in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07894497
- Acronym / sponsor ID
- M20260856
- Conditions
- Ankylosing Spondylitis (AS)
- Keywords
- ankylosing spondylitis, ivarmacitinib, celecoxib, combination therapy, ASAS20
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 26 Oct 2026 (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.
Background: Ankylosing spondylitis (AS) is a chronic, progressive inflammatory disease mainly affecting the spine and sacroiliac joints, causing pain, stiffness, structural damage, and functional disability. NSAIDs remain first-line therapy, while biologics and JAK inhibitors have expanded treatment options. However, many patients have inadequate responses or residual symptoms, and long-term combination with NSAIDs is common despite uncertain incremental benefit. Ivarmacitinib is a highly selective oral JAK1 inhibitor that has shown efficacy in active AS. Whether concomitant celecoxib adds benefit to ivarmacitinib monotherapy remains unknown.
Objectives: To compare the efficacy and safety of ivarmacitinib plus celecoxib versus ivarmacitinib monotherapy in patients with active AS. The primary objective is to compare the proportion achieving an ASAS20 response at week 24.
Methods: This prospective, single-center, randomized, open-label, parallel-group, active-controlled superiority trial will enroll 138 patients with active AS (BASDAI ≥4 and total back pain VAS ≥4) who had inadequate response to at least two NSAIDs or intolerance/contraindication to NSAIDs. Participants will be randomized 1:1 to ivarmacitinib 4 mg once daily plus celecoxib 200 mg twice daily or ivarmacitinib 4 mg once daily for 48 weeks, with as-needed rescue analgesia permitted. The study is open-label, but endpoint assessors and the statistician will be blinded. Key exclusion criteria include prior JAK inhibitor use, major cardiovascular events, active peptic ulcer or bleeding, moderate-to-severe renal insufficiency, pregnancy, significant laboratory abnormalities, and malignancy within 5 years.
Outcomes: The primary endpoint is the proportion achieving ASAS20 at week 24. Secondary endpoints include ASAS20 at weeks 12 and 48; ASAS40 and ASAS5/6; changes in BASDAI, ASDAS-CRP, CRP, ESR, BASMI, BASFI, pain VAS, ASQoL, MASES, GUESS, and SPARCC MRI score; rescue analgesic use; and adverse event incidence, type, severity, and relatedness, with attention to gastrointestinal, cardiovascular, renal, and infectious risks.
Sample Size: Assuming a week-24 ASAS20 rate of 66.7% in the combination group, a 25-percentage-point superiority margin, two-sided α = 0.05, 80% power, and 15% dropout, 69 patients per group are required (total 138).
Statistical Analysis: The full analysis set includes all randomized patients receiving at least one dose, analyzed as randomized. The primary analysis will compare week-24 ASAS20 proportions using a normal-approximation Z-test with 95% CI and p-value; significance is p ≤ 0.025 one-sided. Secondary categorical endpoints will use the Z-test with non-responder imputation; continuous variables will use MMRM or ANCOVA. Safety will be analyzed descriptively in the safety set.
Expected Significance: This trial will provide prospective, head-to-head evidence on whether regular celecoxib adds benefit to ivarmacitinib monotherapy, informing individualized NSAID-JAK inhibitor combination decisions and supporting evidence-based optimization of AS treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivarmacitinib with Celecoxib | Experimental | Drug: Ivarmacitinib with celecoxib |
| Ivarmacitinib | Active comparator | Drug: Ivarmacitinib Monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily signed informed consent prior to any study-related procedure, able to communicate well with investigators, and willing to comply with all protocol requirements.
- Age ≥18 years at the time of signing informed consent.
- Fulfilment of the 1984 modified New York criteria for ankylosing spondylitis.
- Confirmed active AS at screening and before randomization, defined as BASDAI ≥4 and total back pain VAS ≥4.
- Inadequate response to NSAIDs (defined as inadequate response to ≥2 NSAIDs at recommended doses for a total of ≥4 weeks, with each NSAID administered at the recommended dose for ≥2 weeks), or intolerance/contraindication to NSAIDs.
Key exclusion criteria (1 listed)
- concomitant other active inflammatory diseases or infections; prior treatment with any JAK inhibitor; history of major cardiovascular events, active peptic ulcer or bleeding, or moderate-to-severe renal insufficiency; pregnancy, lactation, or planned pregnancy; significant laboratory abnormalities (white blood cell count <3.0 × 10⁹/L; neutrophil count <1.5 × 10⁹/L; hemoglobin <90 g/L; platelet count <100 × 10⁹/L; transaminases >3 × ULN; eGFR <60 mL/min/1.73 m²; positive HBsAg, anti-HIV, syphilis serology, or anti-HCV); known hypersensitivity to the investigational product, celecoxib or any of their components; malignancy within 5 years prior to screening or current malignancy; severe, progressive, uncontrolled cardiovascular, cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematologic, endocrine, neurologic or psychiatric disease (e.g., depression, suicidal tendency); and any other condition judged by the investigator to compromise the evaluation of safety or efficacy.
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 |
|---|---|---|
| Ivarmacitinib with celecoxibIvarmacitinib Combined with Celecoxib | Drug | Ivarmacitinib with Celecoxib |
| Ivarmacitinib MonotherapyIvarmacitinib | Drug | Ivarmacitinib |
Primary outcome
Proportion of participants achieving an ASAS20 response at week 24.
Time frame: Week 24
Participants achieved an ASAS20 response if they had at least 20% improvement and at least 1-unit absolute improvement in at least 3 of the following 4 domains, with no worsening of at least 20% and at least 1 unit in the remaining domain: 1. Patient global assessment of disease activity, measured on a 0-10 visual analog scale (VAS); 2. Total back pain, measured on a 0-10 VAS; 3. Bath Ankylosing Spondylitis Functional Index (BASFI), scored from 0 to 10; 4. Mean of the two morning stiffness items of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), each scored from 0 to 10; Participants who did not meet the ASAS20 criteria, or for whom week-24 data were missing, were counted as non-responders.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivarmacitinib with celecoxib and Ivarmacitinib Monotherapy in people with Ankylosing Spondylitis (AS), run by Peking University Third Hospital.
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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of participants achieving an ASAS20 response at week 24. (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.