Clinical Study of Genakumab for Injection in Patients With Acute Gout

Changchun GeneScience Pharmaceutical Co., Ltd.121 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

121

Conditions

Acute Gout

Interventions

Genakumab for InjectionDRUG

150 mg/1ml/bottle

Placebo for Genakumab for InjectionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Blood samples will be collected at indicated time points for pharmacokinetic analysis.

Time frame: 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

Time frame: 72 hours post-dose

Secondary Outcomes

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

Time frame: 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.

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

Data from ClinicalTrials.gov

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