Health TrialsbyHealthPanel

Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare

ConditionsAcute Gouty ArthritisGout FlareGout FlaresAcute Gout Flare
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAtom Therapeutics Co., Ltd

About this trial

A randomized, double-blind, international multicenter, colchicine and placebo-controlled study to evaluate the efficacy and safety of ABP-745 in subjects with acute gout. Efficacy of ABP-745 in reducing pain and swelling compared with standard colchicine treatment and placebo will be evaluated in participants with acute gout. The primary efficacy measurement will be pain score after treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years old (inclusive), male or female.

Body mass index (BMI)18-40 kg/m2 (inclusive).

Medical history and current findings consistent with diagnosis of gouty arthritis.

Subjects must have experienced 2 or more gout flares within 12 months prior to screening.

Disqualifiers

Administration of oral prednisone ≥ 10 mg or equivalent doses of other glucocorticoids, or use of narcotics, within 24 hours prior to first dose of study drug, or intramuscular, intravenous, or intra-articular injection of any glucocorticoid within 14 days prior to first dose of study drug.

Use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) prior to first dose dose of study drug, at the investigator's discretion.

Administration of colchicine or ABP-745 within 14 days prior to first dose of study drug.

Subjects took any investigational drug in any clinical study within 1 month prior to first dose of study drug and throughout the study period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ABP-745 Dose A

    Drug

    ABP-745 Dose A + Colchicine placebo - tablets (PO)

  • ABP-745 Dose B

    Drug

    ABP-745 Dose B + Colchicine placebo - tablets (PO)

  • Colchicine

    Drug

    ABP-745 placebo + Colchicine - tablets (PO)

  • Placebo

    Drug

    ABP-745 placebo + Colchicine placebo - tablets (PO)

Treatment groups

380 Participants
are divided into 4 treatment groups
Group A: ABP-745 Dose AExperimental treatment 1 intervention
Group B: ABP-745 Dose BExperimental treatment 1 intervention
Group C: ColchicineActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Visual Analog Scale (VAS) pain score of the target joint

Change from baseline in 0-100 mm VAS pain score of the target joint

Time frame
24 hours post the first dose of study drug

Secondary outcomes

1

Change and percentage change from baseline in VAS pain score of the target joint

Time frame
2-8 days post the first dose of study drug
2

Incidence of treatment-emergent adverse events (Safety and Tolerability)

TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG.

Time frame
up to 14 days post the first dose of study drug

Other outcomes

Sponsors and contacts

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Atom Therapeutics Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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