Clinical Study of Genakumab for Injection in Patients With Acute Gout

Acute Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05328531
• Other study ID #: Gensci048GA-Ib/II
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 22, 2021
• Est. completion date: May 28, 2022

Study information

• Verified date: March 2022
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: May 28, 2022
• Est. primary completion date: May 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gout
• Arthritis, Gouty
• Gout

Intervention

Drug:
• Genakumab for Injection
150 mg/1ml/bottle
• Placebo for Genakumab for Injection
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection

Locations

Country	Name	City	State
China	Shanghai Huashan Hospital affiliated to Fudan University	Shanghai	Shanghai

Sponsors (9)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Affiliated Hospital of Nantong University, Changhai Hospital, Hainan General Hospital, Huashan Hospital, Linyi People's Hospital, Shengjing Hospital, The First Affiliated Hospital with Nanjing Medical University, The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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