New pill could replace steroids for painful muscle condition
NCT ID NCT07266168
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called ivarmacitinib for people with polymyalgia rheumatica, a condition causing muscle pain and stiffness. The goal is to see if it can control the disease without needing steroids. About 80 adults aged 50-75 will take either the drug or a placebo, and researchers will measure how well symptoms are managed over 12 weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.