Authorised Therapeutic exploratory (Phase II) Polymyalgia rheumatica

A randomized, double blind, placebo-controlled, phase II, multicentre trial to explore the efficacy and safety of oral AP1189 tablets administered at the dose 100 mg/day for 12 weeks in patients diagnosed with polymyalgia rheumatica and in remission on glucocorticoid

EU CTIS ID: 2026-525343-33-00

What this study is testing

To explore the safety and tolerability of oral AP1189 tablets in patients with PMR. To explore the efficacy of oral 100 mg/day AP1189 tablets over a 12-week treatment period in patients with PMR.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Signed and dated informed consent obtained before undergoing any trial-specific procedure. 2. Male or female aged ≥50 years. 3. Patients diagnosed with PMR fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. 4. Treatment with glucocorticoid for PMR initiated at diagnosis 4 weeks beforefore baseline. 5. Patients in clinical remission at baseline, defined as absence of PMR activity evaluated by the investigator based on symptoms and clinical examination combined with a CRP level be-low 8.0 mg/l. 6. No Giant cell arteritis (GCA) on vascular ultrasound at diagnosis or screening. 7. Patients with C-Reactive Protein (CRP) ≥8 mg/L at the time of diagnosis. 8. Willing and able to comply with the scheduled study visits, the treatment plan, and all study procedures. 9. Females of childbearing potential must have a negative pregnancy test at screening and again at baseline. 10. Sexually active female patients of childbearing potential and male patients must use a highly effective method of birth control (hormonal contraceptives, intrauterine device, vasectomy, bilateral tubal occlusion, sexual abstinence) with their partner during the study and for 90 days after the last dose of study drug or who will remain abstinent during the study and for 90 days after the last dose.

You likely can't join if

  • 1. Previous treatment with glucocorticoids for GCA. 2. Ongoing treatment with oral/intravenous/intramuscular glucocorticoids for other diseases than PMR. 3. Other inflammatory rheumatic diseases (e.g., rheumatoid arthritis, polymyositis, spondyloar-thritis, psoriatic arthritis, gout). 4. Symptoms or findings of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances, limb claudication). 5. Non-inflammatory type of musculoskeletal condition (e.g., osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic and severe enough to interfere with the subject's primary diagnosis of PMR or the evaluation of the effect of the study drug. 6. Gastrointestinal diseases that, in the opinion of the Investigator, may interfere with the absorption or excretion of medications. 7. Severe, progressive, or uncontrolled renal (including CKD stage 4 or higher), hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease. 8. Malignancy (with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ) active during the 5 years preceding the Screening Visit. 9. Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject’s safety during trial participation. 10. Females who are pregnant or lactating. 11. Participation in any other study involving investigational drug(s) within 4 weeks prior to study entry.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.