Clinical trial
A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Name
SSGJ-613-AG-III-01
Description
The purpose of this study is to determine the efficacy and safety of recombinant anti-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-12-01
Trial end
2025-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg
one s.c. injection of SSGJ-613 once, on Day 1.
Arms:
SSGJ-613 200 mg
Other names:
SSGJ-613 200 mg
Placebo
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.
Arms:
SSGJ-613 200 mg
Other names:
0.9% sodium chloride injection
Compound Betamethasone Injection
1 mL i.m. once on Day 1
Arms:
Compound Betamethasone Injection 1 mL
Placebo
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Arms:
Compound Betamethasone Injection 1 mL
Other names:
PBO
Size
500
Primary endpoint
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)
72 hours post-dose
Time to First New Flare
12 weeks
Eligibility criteria
Inclusion Criteria:
* Must be 18 Years to 75 Years, both male and female.
* BMI ≤35 kg/m2.
* Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
* History of ≥ 3 gout flares within the 12 months prior to study randomization.
* Onset of current acute gout flare within 4 days prior to study screening.
* Screening pain intensity of the Target Joint ≥ 50 mm on the 0-100 mm VAS.
* Contraindicated, intolerant or lack efficacy to NSAIDs and/or colchicine.
* Accept uric acid lowering treatment according to the requirements of the protocol.
Exclusion Criteria:
* Gout caused by radiotherapy/chemotherapy, lead, organ transplantation, tumors, 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 8 weeks prior to the start of the study.
* Use of forbidden therapy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2023-12-14
1 organization
2 products
1 indication
Organization
Sunshine Guojian PharmaceuticalIndication
GoutProduct
Betamethasone