NCT06270225

Brief Summary

The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
157

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 5, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 5, 2024

Last Update Submit

August 1, 2024

Conditions

Gout Arthritis

Outcome Measures

Primary Outcomes (1)

  • Numbers of acute gout flares

    12 weeks

Secondary Outcomes (10)

  • Numbers of acute gout flares

    24 weeks

  • Proportions of subjects with at least 1 acute gout flare

    12 weeks

  • Proportions of subjects with at least 1 acute gout flare

    24 weeks

  • Time from randomization to first acute flare.

    24 weeks

  • Duration of acute gout flares.

    12 weeks

  • +5 more secondary outcomes

Study Arms (3)

SSGJ-613 100 mg

EXPERIMENTAL

Subjects will receive 100mg SSGJ-613 on Day 1.

Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg

SSGJ-613 200 mg

EXPERIMENTAL

Subjects will receive 200mg SSGJ-613 on Day 1.

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

Colchicine 0.5mg

ACTIVE COMPARATOR

Subjects will receive 0.5mg/d Colchicine for 12 weeks.

Drug: Colchicine 0.5 mg

Interventions

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mgDRUG

Subjects will receive one s.c. injection of SSGJ-613 on Day 1.

Also known as: SSGJ-613 100mg
SSGJ-613 100 mg
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mgDRUG

Subjects will receive one s.c. injection of SSGJ-613 on Day 1.

Also known as: SSGJ-613 200mg
SSGJ-613 200 mg
Colchicine 0.5 mgDRUG

Subjects will receive 0.5mg/d Colchicine for 12 weeks.

Colchicine 0.5mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 Years to 75 Years, both male and female.
  • BMI ≤40 kg/m2.
  • Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis.
  • ≥2 acute gout flares within 1 year prior to screening.
  • Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.

You may not qualify if:

  • Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc.
  • Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
  • Presence of severe renal function impairment.
  • Intolerance of subcutaneous injection.
  • Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment.
  • Live vaccinations within 8 weeks prior to the start of the study.
  • Use of forbidden therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Huashan Hospital Fudan University-Rheumatology

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Arthritis, Gouty

Interventions

Colchicine

Condition Hierarchy (Ancestors)

GoutArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Hejian Zou, MD

    Shanghai Huashan Hospital Fudan University-Rheumatology

    PRINCIPAL INVESTIGATOR

  • Qinghong Zhou

    Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 21, 2024

Study Start

March 30, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

August 5, 2024

Record last verified: 2024-02

Locations

CN(1)