Today we’re going to look at the ongoing studies and clinical trials specific to gout in adults.
The below list was curated by assessing the ongoing Phase 3 trials for gout, specific for adults, and based in the United States. The dates provided are estimates, and subject to change. The list is primarily studies that have posted updates within 12 months or less.
This series is intended to provide a preview of what new innovations are to come on a given topic, and how might the results of those studies ultimately impact clinical guidelines on the topic(s).
So now let’s jump into the list of Gout Clinical Trials!
Quick View Table of Gout Clinical Trials
| Study Title | Phases | Enrollment | Start Date | Last Update Posted |
|---|---|---|---|---|
| A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy | PHASE 3 | 112 | 8/18/2020 | 2/20/2024 |
| Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients | PHASE 3 | 350 | 10/25/2022 | 8/25/2023 |
| A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II | PHASE 3 | 153 | 11/30/2020 | 2/20/2024 |
| Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare | PHASE 2, PHASE 3 | 300 | 1/6/2023 | 4/3/2024 |
| Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients | PHASE 3 | 2542 | 3/30/2023 | 10/18/2023 |
| Extension Study of ABP-671 in Participants With Gout | PHASE 2, PHASE 3 | 580 | 4/22/2024 | 2/26/2024 |
| Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout | PHASE 2, PHASE 3 | 580 | 8/11/2023 | 2/13/2024 |
Gout Clinical Trials:
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
- Sponsor: Swedish Orphan Biovitrum
- This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy will be performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
- Interventions: DRUG: SEL-212 low-dose|DRUG: SEL-212 high-dose|OTHER: Normal Saline
- Primary Outcomes Measures: Serum uric acid control during month 6, The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) \< 6 mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo, 6 months
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
- Sponsor: LG Chem
- The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
- Interventions: DRUG: Tigulixostat|DRUG: Placebo
- Primary Outcomes Measures: The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6, Serum uric acid (sUA) level will be measured at Month 4,5, and 6, Up to Month 6
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
- Sponsor: Swedish Orphan Biovitrum
- This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
- Interventions: DRUG: SEL-212 low-dose|DRUG: SEL-212 high-dose|OTHER: Placebo
- Primary Outcomes Measures: Serum uric acid control during Month 6, The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) \< 6mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo, 6 months
Study of Latiglutenase in T1D/CD PaStudy of Dapansutrile Tablets in Subjects With an Acute Gout Flare
- Sponsor: Olatec Therapeutics LLC
- The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
- Interventions: DRUG: Dapansutrile|OTHER: Placebo Tablet
- Primary Outcomes Measures: To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain at 72 hours post initial loading dose of IMP, Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain., 72 hours
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
- Sponsor: LG Chem
- The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
- Interventions: DRUG: Tigulixostat|DRUG: Allopurinol|DRUG: Placebo
- Primary Outcomes Measures: The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6, Serum uric acid (sUA) level will be measured at Month 4,5, and 6, Up to Month 6
Extension Study of ABP-671 in Participants With Gout
- Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
- The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).
- Interventions: DRUG: ABP-671|DRUG: Allopurinol
- Primary Outcomes Measures: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L), Week 26|Incidence of treatment-emergent adverse events (Safety and Tolerability), Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation, Week 26
Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout
- Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
- This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.
- Interventions: DRUG: ABP-671|DRUG: Allopurinol|OTHER: Placebo
- Primary Outcomes Measures: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L), Week 28
Potential Guideline That May Be Affected Includes:
- Management of Gout
- American College of Rheumatology (ACR)
- Published: May 20, 2020
- Management of Acute and Recurrent Gout
- American College of Physicians (ACP)
- Publication: January 01, 2017
There you have it – a list of Phase 3 Clinical Trials for Gout as of June 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.