Clinical trial NCT06169891: A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Acute Gout
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 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.

Primary outcomes:
measure: 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)
timeFrame: 72 hours post-dose
measure: Time to First New Flare
timeFrame: 12 weeks
Secondary outcomes:
measure: 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)
timeFrame: At 6, 24, 48 hours and 7 Days post-dose
measure: The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint after study drug administration
timeFrame: Up to 48 weeks
measure: The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration
timeFrame: Up to 48 weeks
measure: Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration
timeFrame: 12 weeks
measure: Time to first use of Rescue Medication
timeFrame: Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period
measure: Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Likert scores for target joint pain
timeFrame: 7 days, 12 weeks, 24 weeks
measure: Time to First New Flare
timeFrame: 24 weeks, 48 weeks
measure: Percentage of Participants with at least 1 new gout flare
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Number of new gout flares
timeFrame: 12 weeks, 24 weeks, 48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Huanshan Hospital Fudan University-Rheumatology
name: Hejian Zou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
name: Qinghong Zhou, MD
role: STUDY_DIRECTOR
References: