Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polymyalgia Rheumatics (PMR)
• Intervention / Treatment: Drug: Ivarmacitinib tablet; Drug: placebo for lvarmacitinib

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huaxiang Wu （0086）-, Professor; Phone Number: 0086-13757118395; Email: wuhx8855@zju.edu.cn
• Study Contact Backup: Name: Liang Zhu （0086）-; Phone Number: 13989880769; Email: zhuliang1059@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age and Weight: 50-75 years old, body weight 40-80 kg.
2. Diagnosis: Confirmed diagnosis of polymyalgia rheumatica (PMR) according to the 2012 ACR/EULAR classification criteria .
3. Disease Activity: CRP-PMR-AS (C-reactive protein polymyalgia rheumatica activity score) ≥17 .

4. 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.

5. Compliance: Participants must understand and agree to adhere to study procedures and restrictions.

   -

Exclusion Criteria:

1. Allergy: Known hypersensitivity to the investigational drug or excipients (including lactose, cellulose-lactose, low-substituted hydroxypropyl cellulose (L-HPC), colloidal silicon dioxide, stearic acid).

2. Comorbidities:

   • Giant cell arteritis (GCA) .
   • Other diffuse connective tissue diseases (e.g., systemic lupus erythematosus), spondyloarthropathy, or active fibromyalgia .

3. Uncontrolled Chronic Conditions:

   • Diabetes (HbA1c ≥8.0%) or uncontrolled hypertension (resting SBP ≥140 mmHg and/or DBP ≥90 mmHg) .
   • Clinically significant ECG abnormalities (e.g., acute myocardial ischemia, myocardial infarction, severe arrhythmia, QTc >500 ms).

4. Organ Dysfunction:

   • Liver/Kidney Impairment:
   • AST/ALT ≥2× upper limit of normal (ULN).
   • Serum creatinine or total bilirubin ≥1.5× ULN .
5. Malignancy: History of malignancy within the past 5 years.

6. 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.
7. Reproductive Plans: Pregnancy planning within 1 year.
8. Prior Medications: Previous use of JAK inhibitors.
9. Thrombosis: History of thrombotic events.
10. Other: Any condition deemed inappropriate by the investigator for participation in this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; 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.	Drug: Ivarmacitinib tablet; Targets JAK kinases to block signal transduction of the JAK-STAT pathway; Drug: placebo for lvarmacitinib; Treatment using blank placebo
Active Comparator: Ivarmacitinib tablet; 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.	Drug: Ivarmacitinib tablet; Targets JAK kinases to block signal transduction of the JAK-STAT pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Achieving CRP-PMR-AS ≤10 Without Oral Glucocorticoids	Measured at Weeks 16, 20, 28, 36, and 48.	up to 48 weeks
Erythrocyte sedimentation rate (ESR)	Changes in Inflammatory Markers	up to 48 weeks
level of C-reactive protein (CRP)	Markers: C-reactive protein (CRP).	up to 48 weeks
level of Interleukin-6 (IL-6).	Cytokine: Interleukin-6 (IL-6).	up to 48 weeks
Cumulative Glucocorticoid Dose at Week 48.	Long-Term Follow-Up Outcome	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.	up to 48 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: First People's Hospital of Hangzhou; The First Affiliated Hospital of Nanchang University; Shanghai Zhongshan Hospital; RenJi Hospital; Qilu Hospital of Shandong University; Ningbo Medical Center Lihuili Hospital; Ruijin Hospital; First Affiliated Hospital of Wenzhou Medical University; Jinhua Central Hospital; The Second Affiliated Hospital of Jiaxing University; Changxing People's Hospital; Affiliated Hospital of Jiaxing University; First Affiliated Hospital of Ningbo University; Huzhou Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: ivarmacitinib
• Other Study ID Numbers: 2025-200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No