RESOMELAGON for Polymyalgia rheumatica

Inclusion criteria

• {"criterion_text":"- 1.\tSigned and dated informed consent obtained before undergoing any trial-specific procedure."}
• {"criterion_text":"- 2.\tMale or female aged ≥50 years."}
• {"criterion_text":"- 3.\tPatients diagnosed with PMR fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria."}
• {"criterion_text":"- 4.\tTreatment with glucocorticoid for PMR initiated at diagnosis 4 weeks beforefore baseline."}
• {"criterion_text":"- 5.\tPatients 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."}
• {"criterion_text":"- 6.\tNo Giant cell arteritis (GCA) on vascular ultrasound at diagnosis or screening."}
• {"criterion_text":"- 7.\tPatients with C-Reactive Protein (CRP) ≥8 mg/L at the time of diagnosis."}
• {"criterion_text":"- 8.\tWilling and able to comply with the scheduled study visits, the treatment plan, and all study procedures."}
• {"criterion_text":"- 9.\tFemales of childbearing potential must have a negative pregnancy test at screening and again at baseline."}
• {"criterion_text":"- 10.\tSexually 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."}

Exclusion criteria

• {"criterion_text":"- 1.\tPrevious treatment with glucocorticoids for GCA."}
• {"criterion_text":"- 2.\tOngoing treatment with oral/intravenous/intramuscular glucocorticoids for other diseases than PMR."}
• {"criterion_text":"- 3.\tOther inflammatory rheumatic diseases (e.g., rheumatoid arthritis, polymyositis, spondyloar-thritis, psoriatic arthritis, gout)."}
• {"criterion_text":"- 4.\tSymptoms or findings of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances, limb claudication)."}
• {"criterion_text":"- 5.\tNon-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."}
• {"criterion_text":"- 6.\tGastrointestinal diseases that, in the opinion of the Investigator, may interfere with the absorption or excretion of medications."}
• {"criterion_text":"- 7.\tSevere, progressive, or uncontrolled renal (including CKD stage 4 or higher), hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease."}
• {"criterion_text":"- 8.\tMalignancy (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."}
• {"criterion_text":"- 9.\tAny 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."}
• {"criterion_text":"- 10.\tFemales who are pregnant or lactating."}
• {"criterion_text":"- 11.\tParticipation in any other study involving investigational drug(s) within 4 weeks prior to study entry."}

Primary endpoints

• {"endpoint_text":"- Safety evaluations include adverse event monitoring, physical examinations, vital sign measurements, and clinical laboratory testing.","definition_or_measurement_approach":"Safety assessments comprised of adverse event monitoring, physical examinations, vital signs and clinical laboratory testing as listed in the endpoint text."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of patients in glucocorticoid-free remission at specified week (exact week number incomplete in text); comparison between 100 mg/day AP1189 and placebo."}
• {"endpoint_text":"- To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: •\tAccumulated glucocorticoid dosage from baseline to week 12. •\tTime to first relapse from baseline to week 12. •\tGlucocorticoid free remission at week 12 (Remission defined as PMR-AS<10).","definition_or_measurement_approach":"Accumulated glucocorticoid dose measured from baseline to week 12; time-to-event analysis for time to first relapse up to week 12; glucocorticoid-free remission at week 12 defined as PMR-AS < 10."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"PMR activity score measured at weeks 4, 8, and 12; primary interest is change from baseline to week 12."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Patient global visual analogue scale measured at weeks 4, 8, 12; primary interest is change from baseline to week 12."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"SF-36 Mental Component Score measured at weeks 4, 8, 12; change from baseline to week 12 is primary."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"SF-36 Physical Component Score measured at weeks 4, 8, 12; change from baseline to week 12 is primary."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Health Assessment Questionnaire Disability Index measured at weeks 4, 8, 12; change from baseline to week 12 is primary."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Patient-reported PMR visual analogue scale at weeks 4, 8, 12; change from baseline to week 12 is primary."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient global VAS at weeks 4, 8, 12; change from baseline to week 12 is primary."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Patient-reported fatigue VAS at weeks 4, 8, 12; change from baseline to week 12 is primary."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Patient-reported morning stiffness VAS at weeks 4, 8, 12; change from baseline to week 12 is primary."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Patient-reported duration of morning stiffness at weeks 4, 8, 12; change from baseline to week 12 is primary."}

Denmark

Earliest CTIS Part Ii Submission Date

04-02-2026

Latest Decision Or Authorization Date

19-03-2026

Processing Time Days

43

Number Of Sites

5

Number Of Participants

60

Primary sponsor

Full Name

Synact Pharma ApS

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

CroxxMed ApS

Responsibilities

sponsorDuties codes: 1,10,11,12,5,6; contact email bte@croxxmed.com

Third parties

• {"country":"Denmark","full_name":"CroxxMed ApS","duties_or_roles":"sponsorDuties codes: 1,10,11,12,5,6","organisation_type":"Industry"}