Acute Gout
Conditions
Keywords
acute gout
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.
Interventions
150 mg/1ml/bottle
DRUGPlacebo for Genakumab for Injection
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection
Sponsors
Huashan Hospital
Hainan General Hospital
Linyi People's Hospital
The Second Affiliated Hospital of Chongqing Medical University
Changhai Hospital
The First Affiliated Hospital with Nanjing Medical University
Shengjing Hospital
Affiliated Hospital of Nantong University
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Phase II is double-blind, participants and investigators are blind.
Intervention model description
Group A : 50mg by single subcutaneous injection; Group B : 100mg by single subcutaneous injection Group C : 195mg by single subcutaneous injection;Group D : 100mg by single subcutaneous injection Group E : 195mg by single subcutaneous injection; Group F: 1ML Compound Betamethasone Injection by single intramuscular injection
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | baseline, Day 14, Day 28, Day 56, Day 84, Day 112 | The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody |
Countries
China
Outcome results
None listed