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Tests treatment safety and results for Acute Gouty Arthritis
Official title Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
ClinicalTrials.gov ID: NCT07145229
What this study is testing
What is ABP-745 Dose A?
ABP-745 Dose A is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute gouty arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Key people are eligible for the study if they meet all of the following
- 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.
- people must have experienced 2 or more gout flares within 12 months prior to screening.
You likely can't join if
- people are excluded from the study if one or more of the following criteria are met:
- Administration of oral prednisone ≥ 10 mg or equivalent doses of other glucocorticoids, or use of narcotics, within 24 hours prior to first dose of...
- 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.
- people took any investigational drug in any clinical study within 1 month prior to first dose of study drug and throughout the study period.
- Administration of pegloticase, or methotrexate, or any biologic IL-1 blocker, TNF inhibitor, or other biological agent within 30 days prior to first...
See the full eligibility criteria
- Key people are eligible for the study if they meet all of the following
- 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.
- people must have experienced 2 or more gout flares within 12 months prior to screening.
- Onset of an acute gout flare, within 6 months
- Patients receiving ULT agents (such as allopurinol, febuxostat, probenecid, etc.) must be on stable doses of these drugs prior to first dose of study drug (and remain on the same dose throughout the Treatment Period).
- people agree to maintain a stable lifestyle (such as diet and exercise) during the study period. Key
- people are excluded from the study if one or more of the following criteria are met:
- 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...
- 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.
- people took any investigational drug in any clinical study within 1 month prior to first dose of study drug and throughout the study period.
- Administration of pegloticase, or methotrexate, or any biologic IL-1 blocker, TNF inhibitor, or other biological agent within 30 days prior to first dose of study drug or within 5 half-lives of the study drug prior to...
- Administration of muscle relaxants, central stimulants, barbiturates, etc. within 30 days prior to first dose of study drug or within 5 half-lives of the drug prior to the first dose of study drug, whichever is longer.
- Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout).
- people with a current diagnosis or history of rheumatoid arthritis, psoriatic arthritis, evidence or suspicion of infectious/septic arthritis, calcium pyrophosphate (CPP) crystal arthritis, acute polyarticular gout (4...
- Current anticoagulation therapy, thrombocytopenia, or diseases with a risk of thrombocytopenia, such as aplastic anemia, hypersplenism, or known hemorrhagic diseases like idiopathic thrombocytopenic purpura or...
- History of malignancy within 5 years prior to screening, excluding localized cancers such as basal cell carcinoma.
- Presence of significant diseases, including but not limited to: uncontrolled hypertension (systolic blood pressure ≥160 or diastolic blood pressure ≥100 mmHg), congestive heart failure (New York Heart Association [NYHA]...
- Women of childbearing potential as defined by Appendix 2.
- Experienced only no or mild gout-related pain prior to first dose of study drug.
- Use of gout flare prophylaxis (e.g., colchicine, NSAIDs, prednisone/methylprednisolone) at the time of randomization based on conversation with subject and self-reported.
- Corona Virus Disease (COVID) vaccination in the 4 weeks prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Arizona, United States
- La Mesa, California, United States
- Norcross, Georgia, United States
- Naperville, Illinois, United States
- Des Moines, Iowa, United States
- Alexandria, Louisiana, United States
- Baton Rouge, Louisiana, United States
- New Orleans, Louisiana, United States
- Lutherville, Maryland, United States
- Gulfport, Mississippi, United States
- Albuquerque, New Mexico, United States
- Morehead City, North Carolina, United States
- Tulsa, Oklahoma, United States
- Austin, Texas, United States
- Botany, New South Wales, Australia
- Brookvale, New South Wales, Australia
- Kotara, New South Wales, Australia
- Newcastle, New South Wales, Australia
- Camberwell, Victoria, Australia
- North Altona, Victoria, Australia
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Arizona, United States; La Mesa, California, United States; Norcross, Georgia, United States; Naperville, Illinois, United States; Des Moines, Iowa, United States; Alexandria, Louisiana, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.