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URAT1 Inhibitor
ABP-671 for Gout
Phase 2 & 3
Recruiting
Research Sponsored by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female participants aged ≥19 and <70 years of age at the time of informed consent
At Screening, participants with gout who are not currently treated with any UA lowering therapy must have an sUA ≥7.5 mg/dL (≥0.450 mmol/L)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 28
Awards & highlights
Study Summary
This trial tests the safety and effectiveness of ABP-671 versus placebo and allopurinol to treat gout. It consists of two parts, assessing different doses and regimens.
Who is the study for?
Adults aged 19-69 with gout, as defined by specific criteria, and a certain level of uric acid in their blood can join. They must not be on uric acid-lowering therapy or agree to stop it. Women who can have children must use reliable birth control, and men too if they're with partners who can get pregnant.Check my eligibility
What is being tested?
The trial is testing ABP-671, a new drug for gout against a placebo and allopurinol (a standard treatment). It's done in two parts: first comparing different doses of ABP-671 to the others, then the best dose from part one against placebo alone.See study design
What are the potential side effects?
Possible side effects aren't specified here but could include reactions similar to other medications for gout such as stomach pain, rash, kidney issues or liver problems. The study will monitor participants closely for any adverse effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 19 and 70 years old.
Select...
I have gout and my uric acid level is 7.5 mg/dL or higher.
Select...
I am a woman who has been postmenopausal for at least 12 months.
Select...
I am willing to stop my gout medication for the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Secondary outcome measures
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)
Side effects data
From 2019 Phase 3 trial • 530 Patients • NCT0201717116%
Rash
12%
Upper respiratory tract infection
10%
Hypoglycaemia
7%
Nasopharyngitis
6%
Influenza like illness
6%
Urinary tract infection
6%
Sinusitis
6%
Diabetic ketoacidosis
5%
Pain in extremity
4%
Bronchitis
3%
Acute myocardial infarction
2%
Osteomyelitis
2%
Abortion spontaneous
1%
Diarrhoea
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Diabetic gastroparesis
1%
Chest pain
1%
Pancreatitis acute
1%
Asthma
1%
Coronary artery disease
1%
Gastrointestinal haemorrhage
1%
Pneumonia
1%
Cardiac arrest
1%
Hyperglycaemia
1%
Death
1%
Cellulitis
1%
Staphylococcal infection
1%
Road traffic accident
1%
Renal failure acute
1%
Pregnancy
1%
Skin ulcer
1%
Amputation
1%
Hyperemesis gravidarum
1%
Angina unstable
1%
Impaired gastric emptying
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allopurinol
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ABP-671Experimental Treatment1 Intervention
Group II: AllopurinolActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABP-671
2020
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.Lead Sponsor
6 Previous Clinical Trials
837 Total Patients Enrolled
6 Trials studying Gout
837 Patients Enrolled for Gout
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults aged 18 and over eligible to join this experimental research?
"This medical experiment is in need of participants aged between 19 and 69."
Answered by AI
Are there any vacancies for clinical trial participants?
"Clinicialtrials.gov has reported that this medical trial is presently recruiting individuals. This study was first posted on the 11th of August 2023 and last updated on the 10th of October 2023."
Answered by AI
May I take part in this medical research endeavor?
"This research requires 580 individuals with gout aged between 19 and 69 years old."
Answered by AI
How many participants are involved in this research endeavor?
"For the study to be carried out as intended, 580 eligible individuals are required. Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. will oversee the trial from Anaheim Clinical Trials (Cenexel ACT) in California and Nature Coast Clinical Research in Florida."
Answered by AI
Are there various research facilities conducting this clinical experiment in the city?
"The clinical trial is running out of Anaheim Clinical Trials (Cenexel ACT) in California, Nature Coast Clinical Research in Florida and JY Research Institute Inc. in Georgia as well as 26 additional sites."
Answered by AI
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