Health TrialsbyHealthPanel

A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment

ConditionGout Arthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

≥4 acute gout flares within 1 year prior to screening

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SSGJ-613 100 mg Q12W

    Drug

    Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12

  • SSGJ-613 200 mg Q12W

    Drug

    Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12

  • SSGJ-613 100 mg Q4W

    Drug

    Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12

  • Colchicine 0.5 mg

    Drug

    Participants will receive 0.5mg bid Colchicine for 24 weeks.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: SSGJ-613 100 mg Q12WExperimental treatment 1 intervention
Group B: SSGJ-613 200 mg Q12WExperimental treatment 1 intervention
Group C: Colchicine 0.5mgActive comparator 1 intervention
Group D: SSGJ-613 100 mg Q4WExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Numbers of acute gout flares

Time frame
24 weeks

Secondary outcomes

1

Numbers of acute gout flares

Time frame
12 weeks
2

Proportions of subjects with at least 1 acute gout flare

Time frame
12、24、48weeks
3

Time from randomization to first acute flare.

Time frame
12、24、48 Weeks
4

Numbers of acute gout flares

Time frame
12、24 Weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: