Polymyalgia Rheumatics (PMR)NCT07266168
Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica
A study testing Ivarmacitinib tablet in people with Polymyalgia Rheumatics (PMR), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The study intends to explore the efficacy and safety of Ivarmacitinib in therapy for polymyalgia rheumatica through a multicenter, randomized, double-blind, placebo-controlled study, and to explore the effectiveness of Ivarmacitinib as an oral glucocorticoid-sparing alternative in the treatment of polymyalgia… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Polymyalgia Rheumatics (PMR)
- What is being tested?
- Ivarmacitinib tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 30 Nov 2028
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age and Weight: 50-75 years old, body weight 40-80 kg.
- Diagnosis: Confirmed diagnosis of polymyalgia rheumatica (PMR) according to the 2012 ACR/EULAR classification criteria .
- Disease Activity: CRP-PMR-AS (C-reactive protein polymyalgia rheumatica activity score) ≥17 .
- Glucocorticoid Use:
- Newly Diagnosed Patients: No glucocorticoid use within 12 weeks prior to enrollment.
- Relapsed Patients: No increase in glucocorticoid dosage within 2 weeks prior to enrollment, and willingness to discontinue current glucocorticoids after enrollment.
- Compliance: Participants must understand and agree to adhere to study procedures and restrictions.
- -
Who cannot join
- Allergy: Known hypersensitivity to the investigational drug or excipients (including lactose, cellulose-lactose, low-substituted hydroxypropyl cellulose (L-HPC), colloidal silicon dioxide, stearic acid).
- Comorbidities:
- Giant cell arteritis (GCA) .
- Other diffuse connective tissue diseases (e.g., systemic lupus erythematosus), spondyloarthropathy, or active fibromyalgia .
- Uncontrolled Chronic Conditions:
- Diabetes (HbA1c ≥8.0%) or uncontrolled hypertension (resting SBP ≥140 mmHg and/or DBP ≥90 mmHg) .
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- Clinically significant ECG abnormalities (e.g., acute myocardial ischemia, myocardial infarction, severe arrhythmia, QTc >500 ms).
- Organ Dysfunction:
- Liver/Kidney Impairment:
- AST/ALT ≥2× upper limit of normal (ULN).
- Serum creatinine or total bilirubin ≥1.5× ULN .
- Malignancy: History of malignancy within the past 5 years.
- Infections:
- Active uncontrolled infections (e.g., tuberculosis, hepatitis B surface antigen (HBsAg) positive with elevated HBV-DNA, HCV, HIV, or active syphilis).
- Severe herpes zoster infection or systemic antimicrobial therapy within 2 weeks prior to randomization.
- Reproductive Plans: Pregnancy planning within 1 year.
- Prior Medications: Previous use of JAK inhibitors.
- Thrombosis: History of thrombotic events.
- Other: Any condition deemed inappropriate by the investigator for participation in this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
The study intends to explore the efficacy and safety of Ivarmacitinib in therapy for polymyalgia rheumatica through a multicenter, randomized, double-blind, placebo-controlled study, and to explore the effectiveness of Ivarmacitinib as an oral glucocorticoid-sparing alternative in the treatment of polymyalgia rheumatica.
Read the detailed description
This study plans to enroll 80 patients with clinically confirmed severe active polymyalgia rheumatica. After enrollment, participants will be randomly assigned in a 1:1 ratio to either the experimental group or the placebo group. All patients will receive a single dose of long-acting glucocorticoid in Week 1. Both groups will continue their assigned treatment until Week 12, when unblinding will occur. Thereafter, the placebo group will switch to ivarmacitinib, and both groups will continue treatment until Week 48, followed by a 4-week safety follow-up period until Week 52.
- Conditions
- Polymyalgia Rheumatics (PMR)
- Being tested
- Ivarmacitinib tablet, placebo for lvarmacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivarmacitinib tabletDrug
Targets JAK kinases to block signal transduction of the JAK-STAT pathway
placebo for lvarmacitinibDrug
Treatment using blank placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | The placebo group received a matched placebo for Ivarmacitinib treatment up to week 12. At week 12, the trial was unblinded, and the placebo group was switched to receive Ivarmacitinib treatment up to week 48, followed by a 4-week safety follow-up period up to week 52. Receives: Drug: Ivarmacitinib tablet; Drug: placebo for lvarmacitinib |
| Ivarmacitinib tablet | Active comparator | The treated group received Ivarmacitinib at 4 mg/day for 48 weeks, followed by a 4-week safety follow-up period up to week 52. Receives: Drug: Ivarmacitinib tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12;
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12
Measured: up to 12 weeks
Secondary outcomes (6)
Proportion of Patients Achieving CRP-PMR-AS ≤10 Without Oral Glucocorticoids
Measured at Weeks 16, 20, 28, 36, and 48.
Measured: up to 48 weeks
Erythrocyte sedimentation rate (ESR)
Changes in Inflammatory Markers
Measured: up to 48 weeks
level of C-reactive protein (CRP)
Markers: C-reactive protein (CRP).
Measured: up to 48 weeks
level of Interleukin-6 (IL-6).
Cytokine: Interleukin-6 (IL-6).
Measured: up to 48 weeks
Cumulative Glucocorticoid Dose at Week 48.
Long-Term Follow-Up Outcome
Measured: up to 48 weeks
Relapse Rate at Week 48 in Both Groups
Relapse Definition: PMR-AS ≥10 AND requiring escalation of glucocorticoid therapy based on the original regimen.
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia Rheumatics (PMR)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Ningbo University, Jinhua Central Hospital, First People's Hospital of Hangzhou, First Affiliated Hospital of Wenzhou Medical University, Huzhou Central Hospital, Ningbo Medical Center Lihuili Hospital, The Second Affiliated Hospital of Jiaxing University, Affiliated Hospital of Jiaxing University, Changxing People's Hospital, Shanghai Zhongshan Hospital, Ruijin Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Nanchang University, RenJi Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266168
- Sponsor's protocol ID
- 2025-200
- Status last verified
- Nov 2025
- First submitted
- 22 Dec 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07266168
- Acronym / sponsor ID
- 2025-200
- Conditions
- Polymyalgia Rheumatics (PMR)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Ningbo University, Jinhua Central Hospital, First People's Hospital of Hangzhou, First Affiliated Hospital of Wenzhou Medical University, Huzhou Central Hospital, Ningbo Medical Center Lihuili Hospital, The Second Affiliated Hospital of Jiaxing University, Affiliated Hospital of Jiaxing University, Changxing People's Hospital, Shanghai Zhongshan Hospital, Ruijin Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Nanchang University, RenJi Hospital
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 5 Dec 2025 (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 study intends to explore the efficacy and safety of Ivarmacitinib in therapy for polymyalgia rheumatica through a multicenter, randomized, double-blind, placebo-controlled study, and to explore the effectiveness of Ivarmacitinib as an oral glucocorticoid-sparing alternative in the treatment of polymyalgia rheumatica.
Detailed description
This study plans to enroll 80 patients with clinically confirmed severe active polymyalgia rheumatica. After enrollment, participants will be randomly assigned in a 1:1 ratio to either the experimental group or the placebo group. All patients will receive a single dose of long-acting glucocorticoid in Week 1. Both groups will continue their assigned treatment until Week 12, when unblinding will occur. Thereafter, the placebo group will switch to ivarmacitinib, and both groups will continue treatment until Week 48, followed by a 4-week safety follow-up period until Week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Ivarmacitinib tablet, Drug: placebo for lvarmacitinibThe placebo group received a matched placebo for Ivarmacitinib treatment up to week 12. At week 12, the trial was unblinded, and the placebo group was switched to receive Ivarmacitinib treatment up to week 48, followed by a 4-week safety follow-up period up to week 52. |
| Ivarmacitinib tablet | Active comparator | Drug: Ivarmacitinib tabletThe treated group received Ivarmacitinib at 4 mg/day for 48 weeks, followed by a 4-week safety follow-up period up to week 52. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age and Weight: 50-75 years old, body weight 40-80 kg.
- Diagnosis: Confirmed diagnosis of polymyalgia rheumatica (PMR) according to the 2012 ACR/EULAR classification criteria .
- Disease Activity: CRP-PMR-AS (C-reactive protein polymyalgia rheumatica activity score) ≥17 .
- Glucocorticoid Use:
- Compliance: Participants must understand and agree to adhere to study procedures and restrictions.
Key exclusion criteria (19 listed)
- Allergy: Known hypersensitivity to the investigational drug or excipients (including lactose, cellulose-lactose, low-substituted hydroxypropyl cellulose (L-HPC), colloidal silicon dioxide, stearic acid).
- Comorbidities:
- Uncontrolled Chronic Conditions:
- Organ Dysfunction:
- Malignancy: History of malignancy within the past 5 years.
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 tabletTargets JAK kinases to block signal transduction of the JAK-STAT pathway | Drug | Ivarmacitinib tablet, placebo |
| placebo for lvarmacitinibTreatment using blank placebo | Drug | placebo |
Primary outcome
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12;
Time frame: up to 12 weeks
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12
6 secondary outcomes
Proportion of Patients Achieving CRP-PMR-AS ≤10 Without Oral Glucocorticoids
Time frame: up to 48 weeks
Erythrocyte sedimentation rate (ESR)
Time frame: up to 48 weeks
level of C-reactive protein (CRP)
Time frame: up to 48 weeks
level of Interleukin-6 (IL-6).
Time frame: up to 48 weeks
Cumulative Glucocorticoid Dose at Week 48.
Time frame: up to 48 weeks
Relapse Rate at Week 48 in Both Groups
Time frame: up to 48 weeks
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 5 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ivarmacitinib tablet in people with Polymyalgia Rheumatics (PMR), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 8 inclusion and 19 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 5 Dec 2025. 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. 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.
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?
Contact Huaxiang Wu （0086）-, Professor (0086-13757118395, wuhx8855@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12; (time frame: up to 12 weeks). 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 5 Dec 2025.