Clinical trial NCT05328531: Clinical Study of Genakumab for Injection in Patients With Acute Gout
Official title: The Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Gout
Keywords: acute gout
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Huashan Hospital
name: Hainan General Hospital
name: Linyi People's Hospital
name: The Second Affiliated Hospital of Chongqing Medical University
name: Changhai Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Shengjing Hospital
name: Affiliated Hospital of Nantong University
First posted: 2022-04-14
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112
measure: pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS)
timeFrame: 72 hours post-dose
Secondary outcomes:
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: up to 16 weeks
measure: High Sensitivity C-reactive Protein (hsCRP)
timeFrame: at 72 hours and 7 days, 4, 8 and 12 weeks post-dose
Other outcomes:
measure: Immunogenicity
timeFrame: baseline, Day 14, Day 28, Day 56, Day 84, Day 112
Locations:
city: Shanghai
country: China
facility: Shanghai Huashan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Hejian Zou
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital of Fudan Univeisity
name: Jing Zhang
role: PRINCIPAL_INVESTIGATOR
References: