Clinical Study of Genakumab for Injection in Patients With Acute Gout

NCT05328531 | Completed Phase 1

• 1 other identifier: Gensci048GA-Ib/II
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Gout

Keywords

acute gout

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

  up to 16 weeks

• High Sensitivity C-reactive Protein (hsCRP)

  at 72 hours and 7 days, 4, 8 and 12 weeks post-dose

Other Outcomes (1)

• Immunogenicity

  baseline, Day 14, Day 28, Day 56, Day 84, Day 112

Study Arms (6)

Genakumab for injection 50mg (Ib)

EXPERIMENTAL

subcutaneous injection, single dose

Drug: Genakumab for Injection

Genakumab for injection 100mg (Ib)

EXPERIMENTAL

subcutaneous injection, single dose

Drug: Genakumab for Injection

Genakumab for injection 195mg (Ib)

EXPERIMENTAL

subcutaneous injection, single dose

Drug: Genakumab for Injection

Genakumab for injection 100mg (II)

EXPERIMENTAL

Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose

Drug: Genakumab for Injection

Genakumab for injection 195mg (II)

EXPERIMENTAL

Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose

Drug: Genakumab for Injection

Compound Betamethasone Injection 1ml (II)

ACTIVE COMPARATOR

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

Interventions

Genakumab for Injection DRUG

150 mg/1ml/bottle

Genakumab for injection 100mg (II); Genakumab for injection 100mg (Ib); Genakumab for injection 195mg (II); Genakumab for injection 195mg (Ib); Genakumab for injection 50mg (Ib)

Placebo for Genakumab for Injection DRUG

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection

Compound Betamethasone Injection 1ml (II)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Huashan Hospital: collaborator
• Hainan General Hospital: collaborator
• Linyi People's Hospital: collaborator
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• Changhai Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Shengjing Hospital: collaborator
• Affiliated Hospital of Nantong University: collaborator

Study Sites (1)

Shanghai Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 310000, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hejian Zou

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Jing Zhang

  Huashan Hospital of Fudan Univeisity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phase II is double-blind, participants and investigators are blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 14, 2022
• Study Start: May 22, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CN (1)