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

NCT ID: NCT07266168

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2028-11-30

Brief 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 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.

Conditions

Polymyalgia Rheumatics (PMR)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Ivarmacitinib tablet

Intervention Type: DRUG

Targets JAK kinases to block signal transduction of the JAK-STAT pathway

placebo for lvarmacitinib

Intervention Type: DRUG

Treatment using blank placebo

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.

Group Type: ACTIVE_COMPARATOR

Ivarmacitinib tablet

Intervention Type: DRUG

Targets JAK kinases to block signal transduction of the JAK-STAT pathway

Interventions

Ivarmacitinib tablet

Targets JAK kinases to block signal transduction of the JAK-STAT pathway

Intervention Type: DRUG

placebo for lvarmacitinib

Treatment using blank placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role: collaborator

Jinhua Central Hospital

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Huzhou Central Hospital

OTHER

Sponsor Role: collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role: collaborator

The Second Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role: collaborator

Changxing People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Huaxiang Wu （0086）-, Professor

Role: CONTACT

wuhx8855@zju.edu.cn

0086-13757118395

Liang Zhu （0086）-

Role: CONTACT

zhuliang1059@zju.edu.cn

13989880769

Other Identifiers

2025-200

Identifier Type: -

Identifier Source: org_study_id