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

December 13, 2023 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SSGJ-613 200 mg
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
one s.c. injection of SSGJ-613 once, on Day 1.
Other Names:
  • SSGJ-613 200 mg
Other: Placebo
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.
Other Names:
  • 0.9% sodium chloride injection
Other: Placebo
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Other Names:
  • PBO
Active Comparator: Compound Betamethasone Injection 1 mL
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.
Other: Placebo
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.
Other Names:
  • 0.9% sodium chloride injection
Other: Placebo
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Other Names:
  • PBO
Drug: Compound Betamethasone Injection
1 mL i.m. once on Day 1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 72 hours post-dose
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
Time Frame: 12 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: At 6, 24, 48 hours and 7 Days post-dose
The change in pain intensity from baseline to 6, 12, 48 hours and 7 days 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).
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
Time Frame: Up to 48 weeks
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).
Up to 48 weeks
The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration
Time Frame: Up to 48 weeks
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.
Up to 48 weeks
Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration
Time Frame: 12 weeks
Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.
12 weeks
Time to first use of Rescue Medication
Time Frame: Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period
The Kaplan Meier method was used to estimate the median time and 95% CI of the 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
Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication
Time Frame: 12 weeks, 24 weeks, 48 weeks
12 weeks, 24 weeks, 48 weeks
Likert scores for target joint pain
Time Frame: 7 days, 12 weeks, 24 weeks
Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme).
7 days, 12 weeks, 24 weeks
Time to First New Flare
Time Frame: 24 weeks, 48 weeks
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares after the first administration of each group, as well as the event incidence and 95% CI.
24 weeks, 48 weeks
Percentage of Participants with at least 1 new gout flare
Time Frame: 12 weeks, 24 weeks, 48 weeks
12 weeks, 24 weeks, 48 weeks
Number of new gout flares
Time Frame: 12 weeks, 24 weeks, 48 weeks
12 weeks, 24 weeks, 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Qinghong Zhou, MD, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
  • Principal Investigator: Hejian Zou, MD, Shanghai Huanshan Hospital Fudan University-Rheumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSGJ-613-AG-III-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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