A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

NCT06169891 | Unknown Phase 3

• 1 other identifier: SSGJ-613-AG-III-01
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Gout

Outcome Measures

Primary Outcomes (2)

• 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).

  72 hours post-dose

• Time to First New Flare

  The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares within 12 weeks after the first administration of each group, as well as the event incidence and 95% CI at 12 weeks.

  12 weeks

Secondary Outcomes (10)

• The Change in Pain Intensity in the Target Joint From Baseline to 6, 24, 48 Hours and 7 Days Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)

  At 6, 24, 48 hours and 7 Days post-dose

• The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint after study drug administration

  Up to 48 weeks

• The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration

  Up to 48 weeks

• Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration

  12 weeks

• Time to first use of Rescue Medication

  Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period

Study Arms (2)

SSGJ-613 200 mg

EXPERIMENTAL

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; Other: Placebo

Compound Betamethasone Injection 1 mL

ACTIVE COMPARATOR

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; Other: Placebo

Interventions

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg DRUG

one s.c. injection of SSGJ-613 once, on Day 1.

Also known as: SSGJ-613 200 mg

SSGJ-613 200 mg

Placebo OTHER

Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.

Also known as: 0.9% sodium chloride injection

SSGJ-613 200 mg

Compound Betamethasone Injection DRUG

1 mL i.m. once on Day 1

Compound Betamethasone Injection 1 mL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hejian Zou, MD

  Shanghai Huanshan Hospital Fudan University-Rheumatology

  PRINCIPAL INVESTIGATOR

• Qinghong Zhou, MD

  Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Qinghong Zhou, MD

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 14, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: November 1, 2025
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share