Clinical Study of Genakumab for Injection in Patients With Acute Gout

The Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout

Study Overview

• Status: Completed
• Conditions: Acute Gout
• Intervention / Treatment: Drug: Genakumab for Injection; Drug: Placebo for Genakumab for Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 310000
      • Shanghai Huashan Hospital affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genakumab for injection 50mg (Ib); subcutaneous injection, single dose	Drug: Genakumab for Injection; 150 mg/1ml/bottle
Experimental: Genakumab for injection 100mg (Ib); subcutaneous injection, single dose	Drug: Genakumab for Injection; 150 mg/1ml/bottle
Experimental: Genakumab for injection 195mg (Ib); subcutaneous injection, single dose	Drug: Genakumab for Injection; 150 mg/1ml/bottle
Experimental: Genakumab for injection 100mg (II); Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose	Drug: Genakumab for Injection; 150 mg/1ml/bottle
Experimental: Genakumab for injection 195mg (II); Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose	Drug: Genakumab for Injection; 150 mg/1ml/bottle
Active Comparator: Compound Betamethasone Injection 1ml (II); Compound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose	Drug: Placebo for Genakumab for Injection; The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Blood samples will be collected at indicated time points for pharmacokinetic analysis.	baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112
pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS)	0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain	72 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)	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	up to 16 weeks
High Sensitivity C-reactive Protein (hsCRP)	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.	at 72 hours and 7 days, 4, 8 and 12 weeks post-dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity	The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody	baseline, Day 14, Day 28, Day 56, Day 84, Day 112

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Changhai Hospital; Huashan Hospital; Shengjing Hospital; The Second Affiliated Hospital of Chongqing Medical University; Hainan General Hospital; Affiliated Hospital of Nantong University; Linyi People's Hospital
• Investigators: Principal Investigator: Hejian Zou, Huashan Hospital; Principal Investigator: Jing Zhang, Huashan Hospital of Fudan Univeisity

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2021
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: acute gout
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Gout; Arthritis, Gouty
• Other Study ID Numbers: Gensci048GA-Ib/II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No