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Acute Gout ArthritisPhase 3NCT05983445

Safety & Efffficacy of Genakumab in Patients With Frequent Flares

A Phase 3 study testing genakumab and Diprospan in people with Acute Gout Arthritis, 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

The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Gout Arthritis
What is being tested?
genakumab and Diprospan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
313 participants
Where
1 siteChina
Study dates
11 Jan 2023to 3 Apr 2024
Phase
Phase 3
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

Who may be able to join

  • Male or female, 18 years ≤ age ≤75 years
  • BMI≤40kg/m2
  • Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout.
  • Start of acute gout flare within 4 days prior to enrolled
  • History of ≥ 2 gout flares within the 12 months prior to study start
  • Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines
  • Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Affiliated Huashan Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Safety & Efficacy of Genakumab in Patients With Frequent Flares

The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).

Read the detailed description

A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.

Being tested
genakumab, placebo for Diprospan, placebo for genakumab, Diprospan
Keywords
Acute Gout Arthritis

What participants receive

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

  • genakumabDrug

    Also called • Gensci048

    200mg s.c.

  • placebo for DiprospanDrug

    i.m.

  • placebo for genakumabDrug

    s.c.

  • DiprospanDrug

    7mg i.m.

Study groups in NCT05983445
Study groupRoleWhat they receive
GenakumabExperimentalGenakumab 200mg s.c
Receives: Drug: genakumab; Drug: placebo for Diprospan
DiprospanActive comparatorDiprospan 7mg im
Receives: Drug: placebo for genakumab; Drug: Diprospan

What is being measured

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

  1. The change in the gout pain intensity in the target joint measured by VAS

    The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.

    Measured: 72 hours post-dose

  2. Time to first new flare

    Measured: 12 weeks

Secondary outcomes (9)

  1. Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)

    Measured: At 6, 24, 48, and 72 hours and 7 days post-dose

  2. The change in the gout pain intensity in the target joint measured by VAS.

    Measured: At 6, 24, 48, and 72 hours and 7 days post-dose

  3. The number of patients with at least 1 new gout flare

    Measured: 12 weeks, 24 weeks, 48 weeks

  4. Time to at Least a 50% Reduction in Baseline Pain Intensity

    Measured: 7 days

  5. Percent Patients Who Took Rescue Medication

    Measured: 24 weeks,48 weeks

  6. Time to first flare

    Measured: 24 weeks, 48 weeks

  7. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: 24weeks, 48weeks

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

    Measured: 24 weeks, 48 weeks

  9. Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period

    Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose.

    Measured: 2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose

Timeline

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

  1. First posted9 Aug 2023
  2. Study start11 Jan 2023
  3. Primary completion3 Apr 2024
  4. Study completion3 Apr 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983445
Sponsor's protocol ID
GenSci048-301
Status last verified
Nov 2024
First submitted
20 Dec 2022
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhu Z, Xue Y, Chu T, Hu J, Gou W, Zhang N, Li J, Yu J, Li R, Li R, Qian L, Duan X, Duan L, Xu Q, Gu F, Lian Y, Zhang X, Zou H. Efficacy and Safety of Firsekibart in Patients with Acute Gout Unsuitable for Standard Therapy: 48-Week Results from an Open-Label Extension of a Randomized Phase 3 Trial. Adv Ther. 2026 Aug;43(8):3432-3450. doi: 10.1007/s12325-026-03611-6. Epub 2026 May 19.

    PubMed 42154367

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing genakumab and Diprospan in people with Acute Gout Arthritis, 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?

The sponsor lists 7 inclusion and 1 exclusion criteria. 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 18 Dec 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The change in the gout pain intensity in the target joint measured by VAS (time frame: 72 hours post-dose). The study lists 2 primary outcomes in all. 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 NCT05983445, 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 18 Dec 2024.

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