Back to resultsClinical Study of Genakumab for Injection in Patients With Acute Gout
Primary Purpose
Acute Gout
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Genakumab for Injection
Placebo for Genakumab for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gout focused on measuring acute gout
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
Sites / Locations
- Shanghai Huashan Hospital affiliated to Fudan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Genakumab for injection 50mg (Ib)
Genakumab for injection 100mg (Ib)
Genakumab for injection 195mg (Ib)
Genakumab for injection 100mg (II)
Genakumab for injection 195mg (II)
Compound Betamethasone Injection 1ml (II)
Arm Description
subcutaneous injection, single dose
subcutaneous injection, single dose
subcutaneous injection, single dose
Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
Compound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax)
Blood samples will be collected at indicated time points for pharmacokinetic analysis.
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT05328531
First Posted
March 29, 2022
Last Updated
April 7, 2022
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Huashan Hospital, Hainan General Hospital, Linyi People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, Changhai Hospital, The First Affiliated Hospital with Nanjing Medical University, Shengjing Hospital, Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT05328531
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2021 (Actual)
Primary Completion Date
May 28, 2022 (Anticipated)
Study Completion Date
May 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Huashan Hospital, Hainan General Hospital, Linyi People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, Changhai Hospital, The First Affiliated Hospital with Nanjing Medical University, Shengjing Hospital, Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gout
Keywords
acute gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigator
Masking Description
Phase II is double-blind, participants and investigators are blind.
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genakumab for injection 50mg (Ib)
Arm Type
Experimental
Arm Description
subcutaneous injection, single dose
Arm Title
Genakumab for injection 100mg (Ib)
Arm Type
Experimental
Arm Description
subcutaneous injection, single dose
Arm Title
Genakumab for injection 195mg (Ib)
Arm Type
Experimental
Arm Description
subcutaneous injection, single dose
Arm Title
Genakumab for injection 100mg (II)
Arm Type
Experimental
Arm Description
Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
Arm Title
Genakumab for injection 195mg (II)
Arm Type
Experimental
Arm Description
Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
Arm Title
Compound Betamethasone Injection 1ml (II)
Arm Type
Active Comparator
Arm Description
Compound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose
Intervention Type
Drug
Intervention Name(s)
Genakumab for Injection
Intervention Description
150 mg/1ml/bottle
Intervention Type
Drug
Intervention Name(s)
Placebo for Genakumab for Injection
Intervention Description
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
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
Title
pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS)
Description
0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain
Time Frame
72 hours post-dose
Secondary Outcome Measure Information:
Title
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
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
Title
High Sensitivity C-reactive Protein (hsCRP)
Description
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
Other Pre-specified Outcome Measures:
Title
Immunogenicity
Description
The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
Time Frame
baseline, Day 14, Day 28, Day 56, Day 84, Day 112
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hejian Zou
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Zhang
Organizational Affiliation
Huashan Hospital of Fudan Univeisity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Huashan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
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Clinical Study of Genakumab for Injection in Patients With Acute Gout
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