2026-525343-33-00招募中2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Safety evaluations include adverse event monitoring, physical examinations, vital sign measurements, and clinical laboratory testing.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent obtained before undergoing any trial-specific procedure.
- •Male or female aged ≥50 years.
- •Patients diagnosed with PMR fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
- •Treatment with glucocorticoid for PMR initiated at diagnosis 4 weeks beforefore baseline.
- •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.
- •No Giant cell arteritis (GCA) on vascular ultrasound at diagnosis or screening.
- •Patients with C-Reactive Protein (CRP) ≥8 mg/L at the time of diagnosis.
- •Willing and able to comply with the scheduled study visits, the treatment plan, and all study procedures.
- •Females of childbearing potential must have a negative pregnancy test at screening and again at baseline.
- •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.
排除标准
- •Previous treatment with glucocorticoids for GCA.
- •Ongoing treatment with oral/intravenous/intramuscular glucocorticoids for other diseases than PMR.
- •Other inflammatory rheumatic diseases (e.g., rheumatoid arthritis, polymyositis, spondyloar-thritis, psoriatic arthritis, gout).
- •Symptoms or findings of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances, limb claudication).
- •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.
- •Gastrointestinal diseases that, in the opinion of the Investigator, may interfere with the absorption or excretion of medications.
- •Severe, progressive, or uncontrolled renal (including CKD stage 4 or higher), hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
- •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.
- •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.
- •Females who are pregnant or lactating.
- •Participation in any other study involving investigational drug(s) within 4 weeks prior to study entry.
结局指标
主要结局
Safety evaluations include adverse event monitoring, physical examinations, vital sign measurements, and clinical laboratory testing.
Safety evaluations include adverse event monitoring, physical examinations, vital sign measurements, and clinical laboratory testing.
次要结局
- To investigate the effect of 100 mg/day AP1189 tablets against placebo tablets by evaluating the proportion of patients in glucocorticoid free remission at week
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: • Accumulated glucocorticoid dosage from baseline to week 12. • Time to first relapse from baseline to week 12. • Glucocorticoid free remission at week 12 (Remission defined as PMR-AS<10).
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: PMR activity score at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest.
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient global VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: SF-36 MCS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: SF-36 PCS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: HAQ-DI at week 4, 8, and 12 with the change from baseline to week 12 being of primary in-terest.
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported PMR VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported global VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest.
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported fatigue VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported morning stiffness VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest.
- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported duration of morning stiffness at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest
研究者
Thomas Jonassen
Scientific
Synact Pharma ApS
研究点 (5)
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