Clinical trial
A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Name
SSGJ-613-AG-Ib/II-01
Description
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.
Trial arms
Trial start
2022-06-29
Estimated PCD
2023-09-01
Trial end
2023-11-01
Status
Recruiting
Phase
Early phase I
Treatment
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)
100 mg subcutaneous (s.c) once
Arms:
SSGJ-613 100 mg (phase Ib)
Other names:
SSGJ-613 100 mg (phase Ib)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)
200 mg subcutaneous (s.c) once
Arms:
SSGJ-613 200 mg (phase Ib)
Other names:
SSGJ-613 200 mg (phase Ib)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)
300 mg subcutaneous (s.c) once
Arms:
SSGJ-613 300 mg (phase Ib)
Other names:
SSGJ-613 300 mg (phase Ib)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)
one s.c. injection of SSGJ-613 once, on Day 1.
Arms:
SSGJ-613 200 mg (phase II)
Other names:
SSGJ-613 200 mg (phase II)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)
one s.c. injection of SSGJ-613 once, on Day 1.
Arms:
SSGJ-613 300 mg (phase II)
Other names:
SSGJ-613 300 mg (phase II)
Compound Betamethasone Injection (phase II)
1 mL i.m. once on Day 1
Arms:
Compound Betamethasone Injection 1 mL (phase II)
Placebo (phase II)
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Arms:
Compound Betamethasone Injection 1 mL (phase II)
Other names:
PBO
Size
120
Primary endpoint
Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From baseline through 24 weeks
Phase Ib: Incidence and Severity of Abnormalities in Vital Signs/Physical Examinations, Laboratory Examinations and Other Relevant Examinations
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)
Baseline, at 72 hrs post-dose
Eligibility criteria
Inclusion Criteria:
* Must be 18 Years to 65 Years, both male and female
* Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
* Presence of acute gout flare for no longer than 7 days
* Baseline pain intensity \> or = to 50 mm on the 0-100 mm VAS
* Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both
Exclusion Criteria:
* Secondary gout (such as gout caused by chemotherapy, transplant gout, etc.)
* Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
* Presence of severe renal function impairment
* Intolerance of subcutaneous and intramuscular injection
* Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
* History of malignant tumor within 5 years before screening
* Live vaccinations within 3 months prior to the start of the study
* Use of forbidden therapy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2022-10-20
1 organization
3 products
1 indication
Organization
Sunshine Guojian PharmaceuticalIndication
GoutProduct
Compound Betamethasone