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Acute GoutPhase 2Gensci 048-203NCT05936268

Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare

A Phase 2 study testing Genakumab for injection and Colchicine in people with Acute Gout and Gout Flare, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Gout, Gout Flare
What is being tested?
Genakumab for injection and Colchicine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteChina
Study dates
21 Jul 2023to 28 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Male or female, 18 years ≤ age ≤ 75 years;
  2. BMI ≤ 40kg/m2
  3. Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
  4. Start of acute gout flare within 3 days prior to enrolled;
  5. History of ≥2 gout flare within 12 months prior to study start;
  6. Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Affiliated Huashan Hospital

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

Read the detailed description

Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.

Being tested
Genakumab for injection, Colchicine
Keywords
Acute gout, Gout flare

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genakumab for injectionDrug

    150 mg/1ml/bottle

  • ColchicineDrug

    0.5mg/table

Study groups in NCT05936268
Study groupRoleWhat they receive
Genacumab groupExperimentalGenakumab 200mg single injection
Receives: Drug: Genakumab for injection
cholchicine groupActive comparatorColchicine 0.5mg qd po.for 12 weeks
Receives: Drug: Colchicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 72hours target joint VAS change from baseline

    72hours target joint VAS change from baseline

    Measured: 72h±2h

Secondary outcomes (4)

  1. Pain intensity

    target joint VAS Target joint VAS change from baseline Time to first VAS<=50% baseline VAS Time to first VAS<=30mm Time to first VAS<=10mm

    Measured: 6hours, 24hours, 48hours, 72hours, Day 8,

  2. Recurrence of flare

    Proportion of patients who have at least 1 flare Time to first flare

    Measured: 12 weeks after the last dose

  3. Safety outcome

    AE, laboratory examination, ECG, vital signs and physical examination

    Measured: 12weeks

  4. immunogenic outcome

    The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody

    Measured: 12 weeks after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start21 Jul 2023
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936268
Sponsor's protocol ID
GenSci048-203
Acronym
Gensci 048-203
Status last verified
Nov 2024
First submitted
30 Jun 2023
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kong N, Xue Y, Mao L, Qian L, Guo H, Hu J, Yuan F, Li R, Duan X, Yu J, Gou W, Yang L, Wei H, Li R, Xu Q, Luo T, Zhang X, Zou H. Efficacy and Safety of Firsekibart Compared to Etoricoxib for Gout Flares: A Phase 2, Multicenter, Open-label, Active-controlled, Randomized Non-inferiority Trial. Rheumatol Ther. 2025 Oct;12(5):975-990. doi: 10.1007/s40744-025-00790-6. Epub 2025 Aug 20.

    PubMed 40833487

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Genakumab for injection and Colchicine in people with Acute Gout and Gout Flare, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

72hours target joint VAS change from baseline (time frame: 72h±2h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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