Trial · NCT07414394
Tigulixostat (IBI128) vs Febuxostat in Gout
NCT07414394, Phase 3, Active not recruiting, Innovent Biologics Technology Limited (Shanghai R&D Center)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Tigulixostat (IBI128) vs Febuxostat in Gout. Trials, record NCT07414394. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07414394
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tigulixostat (IBI128) vs Febuxostat in Gout
- NCT number
- NCT07414394
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 600 participants, actual
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)
- Conditions
- Gout
- Interventions
- Febuxostat, Tigulixostat
- First posted
- 2026-02-17
- Last updated
- 2026-09-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 24 | At Week 24 | Percentage of participants with serum uric acid (sUA) level below 360 μmol/L at Week 24 after randomized treatment with Tigulixostat (IBI128) or Febuxostat in Chinese participants with gout. |
| Secondary | Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 12 | At Week 12 | Percentage of participants with serum uric acid (sUA) level below 360 μmol/L at Week 12. |
| Secondary | Proportion of Participants with Serum Uric Acid <360 μmol/L at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Proportion of participants achieving a serum uric acid (sUA) level \<360 μmol/L at each scheduled visit during the 52-week study period. |
| Secondary | Proportion of Participants Achieving Serum Uric Acid <300 μmol/L at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Percentage of participants with serum uric acid (sUA) level below 300 μmol/L at each scheduled visit during the 52-week treatment period. |
| Secondary | Proportion of Participants Achieving Serum Uric Acid <240 μmol/L at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Percentage of participants with serum uric acid (sUA) level below 240 μmol/L at each scheduled visit during the 52-week treatment period. |
| Secondary | Mean Change From Baseline in Serum Uric Acid Level at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Mean change from baseline in serum uric acid (sUA) level at each scheduled visit during the 52-week treatment period. |
| Secondary | Mean Percent Change From Baseline in Serum Uric Acid Level at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Mean percent change from baseline in serum uric acid (sUA) level at each scheduled visit the 52-week treatment period. |
| Secondary | Number of Participants with Adverse Events (AEs)/Serious Adverse Events (SAEs) | Baseline through Week 54 (end of safety follow-up) | Percentage of participants who have experienced AEs/SAEs. |
| Secondary | Proportion and Number of Gout Flares per Participant | Every 4 weeks from first dose through Week 52 | Proportion of participants experiencing gout flares and the number of gout flares per participant during each 4-week interval following initiation of study treatment. |
| Secondary | Change From Baseline in Renal Function Parameters | At Week 12, 24, and 52 | Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 12, 24, and 52. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07414394
GET https://conductscience.org/api/trials/v1/NCT07414394/registered