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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 weeks
Treatment ~ Varies
Follow Up ~week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)
Secondary outcome measures
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 • NCT02017171
16%
Rash
12%
Upper respiratory tract infection
10%
Hypoglycaemia
7%
Nasopharyngitis
6%
Sinusitis
6%
Urinary tract infection
6%
Diabetic ketoacidosis
6%
Influenza like illness
5%
Pain in extremity
4%
Bronchitis
3%
Acute myocardial infarction
2%
Abortion spontaneous
2%
Osteomyelitis
1%
Death
1%
Chest pain
1%
Cellulitis
1%
Hyperemesis gravidarum
1%
Pregnancy
1%
Asthma
1%
Skin ulcer
1%
Amputation
1%
Road traffic accident
1%
Cardiac arrest
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
~373 spots leftby Jul 2025
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