Clinical Study of Genakumab for Injection in Patients With Acute Gout
- Conditions
- Acute Gout
- Interventions
- Drug: Genakumab for InjectionDrug: Placebo for Genakumab for Injection
- Registration Number
- NCT05328531
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout
- Detailed Description
Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group.
Phase II: randomized, double-blind, active control design.There are 2 dose groups of Genakumab for Injection with 30 participant s in each group and 1 group of Compound Betamethasone Injection with 30 praticipants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Male or female, 18 years ≤ age ≤65 years
- Meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of acute arthritis of primary gout
- Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
- Body mass index of less than or equal to 45 kg/m2
- Onset of current acute gout flare within 5 days prior to study entry
- Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
- History of gout flare prior to study entry
Exclusion criteria:
- evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
- Presence of severe renal function impairment
- Use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry
- Live vaccinations within 3 months prior to randomization
- Requirement for administration of antibiotics against latent tuberculosis (TB)
- Any active or recurrent bacterial, fungal, or viral infection
- QTc>450ms for male, QTc>470ms for female
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genakumab for injection 50mg (Ib) Genakumab for Injection subcutaneous injection, single dose Genakumab for injection 100mg (Ib) Genakumab for Injection subcutaneous injection, single dose Genakumab for injection 195mg (Ib) Genakumab for Injection subcutaneous injection, single dose Genakumab for injection 100mg (II) Genakumab for Injection Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose Genakumab for injection 195mg (II) Genakumab for Injection Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose Compound Betamethasone Injection 1ml (II) Placebo for Genakumab for Injection Compound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112 Blood samples will be collected at indicated time points for pharmacokinetic analysis.
pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS) 72 hours post-dose 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) up to 16 weeks Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards
High Sensitivity C-reactive Protein (hsCRP) at 72 hours and 7 days, 4, 8 and 12 weeks post-dose High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (except Visit 2 and Visit 4 ) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.
Trial Locations
- Locations (1)
Shanghai Huashan Hospital affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China