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Tigulixostat 200mg for Gout

Arizona Research Clinic, PLLC, Chandler, AZ
Gout+3 More ConditionsTigulixostat - Drug
Eligibility
18 - 85
All Sexes

Study Summary

This trial tests if a drug can help treat gout by decreasing uric acid levels in the body.

Eligible Conditions
  • Gout
  • High Uric Acid
  • Gout Flare
  • Gouty Tophi

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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1
Dietary Intervention
1
Dexrazoxane
1
Dapansutrile

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: From Month 6 to Month 12

Month 12
Proportion of subjects with at least one gout flare from Month 6 to Month 12.
Up to Month 12
Incidence rate of adverse event
Proportion of subjects with complete resolution of ≥1 target tophus by Month 12
Up to Month 6
The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Dietary Intervention
1
Dexrazoxane
2
Dapansutrile

Side Effects for

Allopurinol
16%Rash
12%Upper respiratory tract infection
10%Hypoglycaemia
7%Nasopharyngitis
6%Diabetic ketoacidosis
6%Influenza like illness
6%Sinusitis
6%Urinary tract infection
5%Pain in extremity
4%Bronchitis
3%Acute myocardial infarction
2%Abortion spontaneous
2%Osteomyelitis
1%Death
1%Renal failure acute
1%Impaired gastric emptying
1%Cellulitis
1%Cerebrovascular accident
1%Skin ulcer
1%Staphylococcal infection
1%Cardiac arrest
1%Pneumonia
1%Asthma
1%Hyperglycaemia
1%Myocardial infarction
1%Cardiac failure congestive
1%Coronary artery disease
1%Amputation
1%Pancreatitis acute
1%Angina unstable
1%Diarrhoea
1%Hyperemesis gravidarum
1%Chest pain
1%Pregnancy
1%Gastrointestinal haemorrhage
1%Road traffic accident
1%Diabetic gastroparesis
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02017171) in the Allopurinol ARM group. Side effects include: Rash with 16%, Upper respiratory tract infection with 12%, Hypoglycaemia with 10%, Nasopharyngitis with 7%, Diabetic ketoacidosis with 6%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5 Treatment Groups

Titrated allopurinol (100-800mg)
1 of 5
Tigulixostat 200mg
1 of 5
Tigulixostat 100mg
1 of 5
Tigulixostat 300mg
1 of 5
Placebo
1 of 5

Active Control

Experimental Treatment

Non-Treatment Group

2542 Total Participants · 5 Treatment Groups

Primary Treatment: Tigulixostat 200mg · Has Placebo Group · Phase 3

Tigulixostat 200mg
Drug
Experimental Group · 1 Intervention: Tigulixostat · Intervention Types: Drug
Tigulixostat 100mg
Drug
Experimental Group · 1 Intervention: Tigulixostat · Intervention Types: Drug
Tigulixostat 300mg
Drug
Experimental Group · 1 Intervention: Tigulixostat · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Titrated allopurinol (100-800mg)
Drug
ActiveComparator Group · 1 Intervention: Allopurinol · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from month 6 to month 12

Who is running the clinical trial?

LG ChemLead Sponsor
55 Previous Clinical Trials
27,942 Total Patients Enrolled
8 Trials studying Gout
657 Patients Enrolled for Gout
Jisoo Lee, MDStudy DirectorLG Chem
2 Previous Clinical Trials
8,350 Total Patients Enrolled
1 Trials studying Gout
350 Patients Enrolled for Gout

Eligibility Criteria

Age 18 - 85 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What is the cap on the number of participants in this experiment?

"The study necessitates the involvement of 2542 individuals who comply with its inclusion criteria. Patients can join from either Alliance for Multispecialty Research, LLC in Daphne, Arizona or Syed Research Consultants, LLC in Muscle Shoals, California." - Anonymous Online Contributor

Unverified Answer

What safety considerations should be taken into account when administering Tigulixostat 200mg?

"Tigulixostat 200mg has been evaluated as 3 on a scale of 1 to 3 due to the established evidence from its Phase 3 trial demonstrating efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Does this research permit individuals aged 35 and above to take part?

"The age range for potential participants in this clinical trial are those who have reached the legal age of consent and are below 85 years old." - Anonymous Online Contributor

Unverified Answer

Are there currently vacancies for individuals to participate in this research?

"Affirmative. According to clinicaltrials.gov, the trial launched on March 30th 2023 and was adjusted as recently as May 22nd 2023 is presently searching for participants. In total, 74 sites will be admitting 2542 patients into this investigation." - Anonymous Online Contributor

Unverified Answer

How widely geographically dispersed is this scientific investigation in the USA?

"The study is accessible in 74 distinct clinical sites, including Alliance for Multispecialty Research, LLC (Daphne), Syed Research Consultants, LLC (Muscle Shoals) and Arizona Research Clinic PLLC (Sheffield)." - Anonymous Online Contributor

Unverified Answer

How can I register for this research project?

"This clinical trial seeks 2,542 individuals aged between 18-85 suffering from gout. In addition to this qualification, participants must be either male or female; possess hyperuricemia and meet the ACR/EULAR 2015 criteria for gout; have a Body Mass Index ≤50 kg/m2 and an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1); those currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening should also undergo washout in order" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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