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Monoclonal Antibodies
ABP-671 for Gout
Phase 2 & 3
Waitlist Available
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
Be older than 18 years old
Must not have
Is intolerant or unwilling to take colchicine or naproxen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights
Summary
"This trial aims to see if ABP-671 is safe and effective in reducing uric acid levels in people with gout who are continuing from a previous study."
Who is the study for?
This trial is for people with gout who finished the initial 28-week treatment in Study ABP-671-301 and are doing well on the medication. They can't join if they have new health or mental issues, plan to get pregnant or breastfeed soon, or can't take colchicine or naproxen.
What is being tested?
The study tests the safety and effectiveness of a drug called ABP-671 in lowering uric acid levels in gout patients. It's an extension of a previous study where participants continue with their current treatment from that study.
What are the potential side effects?
While specific side effects aren't listed here, generally such trials monitor for any adverse reactions related to liver function, kidney function, allergic reactions, gastrointestinal issues, and other common drug-related complications.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot or do not want to take colchicine or naproxen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Side effects data
From 2019 Phase 3 trial • 530 Patients • NCT0201717116%
Rash
12%
Upper respiratory tract infection
10%
Hypoglycaemia
7%
Nasopharyngitis
6%
Diabetic ketoacidosis
6%
Urinary tract infection
6%
Sinusitis
6%
Influenza like illness
5%
Pain in extremity
4%
Bronchitis
3%
Acute myocardial infarction
2%
Abortion spontaneous
2%
Osteomyelitis
1%
Cellulitis
1%
Chest pain
1%
Cardiac arrest
1%
Pregnancy
1%
Skin ulcer
1%
Amputation
1%
Asthma
1%
Death
1%
Road traffic accident
1%
Hyperemesis gravidarum
1%
Myocardial infarction
1%
Diarrhoea
1%
Impaired gastric emptying
1%
Pancreatitis acute
1%
Angina unstable
1%
Coronary artery disease
1%
Cardiac failure congestive
1%
Diabetic gastroparesis
1%
Gastrointestinal haemorrhage
1%
Pneumonia
1%
Staphylococcal infection
1%
Hyperglycaemia
1%
Cerebrovascular accident
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allopurinol
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ABP-671Experimental Treatment1 Intervention
Group II: AllopurinolActive Control1 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
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