A Phase 1/2 interventional study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib) and Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib) in Acute Gout, sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. Status unknown at 3 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-20.
Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
232 studies on the registry are indexed under Gout; 45 are open to participants now.
This study's planned enrollment of 120 is close to the median of 121 across 202 interventional studies indexed under Gout.
Browse Gout studies →Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. is the lead sponsor of 56 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dose Arm 1 (phase Ib): SSGJ-613 100 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)
Dose Arm 2 (phase Ib): SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)
Dose Arm 3 (phase Ib): SSGJ-613 300 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)
Dose Arm 4 (phase II): SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.
Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)
Dose Arm 5 (phase II): SSGJ-613 300 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.
Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)
Dose Arm 6 (phase II): Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1.
Drug: Compound Betamethasone Injection (phase II) · Other: Placebo (phase II)
100 mg subcutaneous (s.c) once
Also known as: SSGJ-613 100 mg (phase Ib)
200 mg subcutaneous (s.c) once
Also known as: SSGJ-613 200 mg (phase Ib)
300 mg subcutaneous (s.c) once
Also known as: SSGJ-613 300 mg (phase Ib)
one s.c. injection of SSGJ-613 once, on Day 1.
Also known as: SSGJ-613 200 mg (phase II)
one s.c. injection of SSGJ-613 once, on Day 1.
Also known as: SSGJ-613 300 mg (phase II)
1 mL i.m. once on Day 1
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Also known as: PBO
Phase 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
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
Plan to share: No
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.