A Multicenter, Double-blind, Phase 2b/3 Extension Study to Assess the Safety and Efficacy of ABP-671 in Participants With Gout Who Completed the Double-blind Treatment Period in Study ABP-671-301
ClinicalTrials.gov processed this data on September 12, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
TERMINATED (See Contacts and Locations)Verified August 2024 by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Sponsor
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.Information Provided by (Responsible Party)
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.Clinicaltrials.gov Identifier
NCT06276556Other Study ID Numbers: ABP-671-302
First Submitted: February 12, 2024
First Posted: February 26, 2024
Last Update Posted: September 19, 2024
Last Verified: August 2024
History of Changes
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Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 43 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | Quadruple |
Primary Purpose | Treatment |
Official Title | A Multicenter, Double-blind, Phase 2b/3 Extension Study to Assess the Safety and Efficacy of ABP-671 in Participants With Gout Who Completed the Double-blind Treatment Period in Study ABP-671-301 |
Study Start Date | April 22, 2024 |
Actual Primary Completion Date | September 5, 2024 |
Actual Study Completion Date | September 5, 2024 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) [Week 26]
- Incidence of treatment-emergent adverse events (Safety and Tolerability) [Week 26] Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation
Secondary Outcome Measures
- Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) [Week 26]
Eligibility Criteria
Ages Eligible for Study | 19 Years to 75 Years (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. |
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Locations |
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More Information
Additional Relevant MeSH Terms
- Gout
- Arthritis
- Joint Diseases
- Musculoskeletal Diseases
- Crystal Arthropathies
- Rheumatic Diseases
- Purine-Pyrimidine Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Genetic Diseases, Inborn
- Metabolic Diseases