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Not yet recruiting NCT07266168

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

No phase Interventional Polymyalgia Rheumatics (PMR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ivarmacitinib tablet, placebo for lvarmacitinib.
Who it may be relevant to
Registry conditions: Polymyalgia Rheumatics (PMR). Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Overview

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.

Interventions

  • Drug Ivarmacitinib tablet
    Targets JAK kinases to block signal transduction of the JAK-STAT pathway
  • Drug placebo for lvarmacitinib
    Treatment using blank placebo

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

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Exclusion criteria

  • 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) .
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07266168 · 2025-200

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗