The purpose of this study is to determine the target dose of phase II and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-IL-1β humanized monoclonal antibody injection at different doses in Chinese participants with acute gout.
The phase Ib study is a multi-center, open label, dose escalation study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection and to determine the target dose of phase II for the treatment of acute flare in Chinese gout patients in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. There are 3 dose groups (100 mg、200 mg and 300 mg) in phase Ib and 10 participants in each group. The phase II study is a dose-ranging, multi-center, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of 2 dose regimens (200 mg and 300 mg, based on the outcome of phase Ib) of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection for the treatment of acute flare in Chinese gout patients in whom NSAIDs and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. The phase II recommended dose of SSGJ-613 in subjects with acute gouty was determined according to the phase Ib interim analysis results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
100 mg subcutaneous (s.c) once
200 mg subcutaneous (s.c) once
300 mg subcutaneous (s.c) once
Site 02
Wuhan, Hubei, China
RECRUITINGSite 03
Linyi, Shandong, China
NOT_YET_RECRUITINGSite 01
Shanghai, Shanghai Municipality, China
RECRUITINGPhase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the safety characteristics.
Time frame: From baseline through 24 weeks
Phase Ib: Incidence and Severity of Abnormalities in Vital Signs/Physical Examinations, Laboratory Examinations and Other Relevant Examinations
To investigate the safety characteristics.
Time frame: From baseline through 24 weeks
Phase II: The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The change in pain intensity from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Time frame: Baseline, at 72 hrs post-dose
Phase Ib: Pharmacokinetic (PK) Cmax
PK parameters (Cmax) following single dose.
Time frame: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) Tmax
PK parameters (Tmax) following single dose.
Time frame: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) AUC 0-t
PK parameters (AUC 0-t) following single dose.
Time frame: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) AUC 0-∞
PK parameters (AUC 0-∞) following single dose.
Time frame: From baseline through 24 weeks
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one s.c. injection of SSGJ-613 once, on Day 1.
one s.c. injection of SSGJ-613 once, on Day 1.
1 mL i.m. once on Day 1
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Phase Ib: Pharmacokinetic (PK) t1/2
PK parameters (t1/2) following single dose.
Time frame: From baseline through 24 weeks
Phase Ib: The Pain Intensity in the Target Joint at 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The pain intensity post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain.
Time frame: At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks post-dose
Phase II: The Pain Intensity in the Target Joint at 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The pain intensity post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain.
Time frame: At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks post-dose
The Change in Pain Intensity in the Target Joint From Baseline to 6, 12, 24, 48 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The change in pain intensity from baseline to 6, 12, 24, 48 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Time frame: Baseline, at 6, 12, 24, 48 hrs post-dose
The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint Within 7 Days after study drug administration
The time to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).
Time frame: Baseline, within 7 days after study drug administration
The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint Within 12 Weeks after study drug administration
The time to complete pain remission in Pain intensity from baseline as measured by a 5-point Likert scale for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.
Time frame: Baseline, within 12 weeks after study drug administration
Percentage of Participants Taking Rescue Medication Within 7 Days After Study Drug Administration
Participants who had difficulty in tolerating their pain after the 12 and 72 hours post-dose pain assessments were allowed to take rescue medication.
Time frame: 7 days after study drug administration