GoutPhase 2Gensci 048-202NCT05936281
A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
A Phase 2 study testing Genakumab for injection and Colchicine in people with Gout and Gout Initiating Urate-loweringUrate-lowering Therapy, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout, Gout Initiating Urate-loweringUrate-lowering Therapy
- What is being tested?
- Genakumab for injection and Colchicine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 19 Jan 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
- Signed written informed consent before any study procedure is performed.
- Male or female, 18 years ≤ age ≤ 75 years.
- BMI ≤ 40kg/m2.
- Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of arthritis of primary gout.
- History of ≥2 gout flare within 12 months prior to screening.
- Willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Randomized, Open-lable, Multi-center, Active-controlled Phase 2 Study for Evaluating Efficacy and Safety of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering
To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering
Read the detailed description
A randomized, open-lable, multi-center, active-controlled Phase 2 study. Patients are randomized to Genakumab 100mg single injection group, Genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.
- Being tested
- Genakumab for injection, Colchicine
- Keywords
- Gout, urate-loweringUrate-lowering therapy
- Medical subject headings
- Gout
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/ vial
ColchicineDrug
0.5 mg/table
| Study group | Role | What they receive |
|---|---|---|
| Genakumab group | Experimental | Genakumab 100mg single injection、Genakumab 200mg single injection Receives: Drug: Genakumab for injection |
| Colchicine group | Active comparator | Oral colchicine 0.5mg once a day for 12 weeks Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Gout Flares Per Participant
Measured: Baseline to Week 12
Secondary outcomes (4)
Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization
Measured: Baseline to Week 12
Time from Randomization to the First Flare
Measured: Baseline to Week 12
Mean duration of flares
Measured: Baseline to Week 12
5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start20 Jul 2023
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Gout patients initiating urate-lowering therapy Group A: Genakumab 100mg single injection; Group B: Genakumab 200mg single injection;Group C: Oral colchicine 0.5mg once a day for 12 weeks
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Responsible party
- Sponsor
- Investigators
- Hejian Zou, Principal investigator, Fudan University Affiliated Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936281
- Sponsor's protocol ID
- GenSci 048-202
- Acronym
- Gensci 048-202
- Status last verified
- Dec 2024
- First submitted
- 30 Jun 2023
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-lable, Multi-center, Active-controlled Phase 2 Study for Evaluating Efficacy and Safety of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering
- ClinicalTrials.gov ID
- NCT05936281
- Acronym / sponsor ID
- Gensci 048-202 / GenSci 048-202
- Keywords
- Gout, urate-loweringUrate-lowering therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering
Detailed description
A randomized, open-lable, multi-center, active-controlled Phase 2 study. Patients are randomized to Genakumab 100mg single injection group, Genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Gout patients initiating urate-lowering therapy Group A: Genakumab 100mg single injection; Group B: Genakumab 200mg single injection;Group C: Oral colchicine 0.5mg once a day for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Genakumab group | Experimental | Drug: Genakumab for injectionGenakumab 100mg single injection、Genakumab 200mg single injection |
| Colchicine group | Active comparator | Drug: ColchicineOral colchicine 0.5mg once a day for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genakumab for injection150 mg/1ml/ vial | Drug | Genakumab group |
| Colchicine0.5 mg/table | Drug | Colchicine group |
Primary outcome
Mean Number of Gout Flares Per Participant
Time frame: Baseline to Week 12
4 secondary outcomes
Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization
Time frame: Baseline to Week 12
Time from Randomization to the First Flare
Time frame: Baseline to Week 12
Mean duration of flares
Time frame: Baseline to Week 12
5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
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Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hejian Zou principal investigator
Fudan University Affiliated Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genakumab for injection and Colchicine in people with Gout and Gout Initiating Urate-loweringUrate-lowering Therapy, 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 1 Jan 2025. 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?
Mean Number of Gout Flares Per Participant (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2025.