Extension Study of ABP-671 in Participants With Gout
Megadott ok: For business consideration, a new long-term safety study will be conducted in the next new pivotal studies.
A legfontosabb adatok
- Hol
- Anaheim, Annapolis, Atlanta, Brooksville, Brownsville, Chattanooga, Columbus, Crystal River, Cutler Bay, DeLand, Duncansville, Elizabethton, Gulfport, Jacksonville, Las Vegas, Miami, New Orleans, Newton, Omaha, Orlando, Palmetto Bay, Sacramento, Salisbury, San Antonio, Santa Fe, Tempe és Tucson (Egyesült Államok)Mind a 33 helyszín megnézése
- Fázis
- 2/3. fázis
Helyszínek itt: Egyesült Államok
- Anaheim Clinical Trials (Cenexel ACT)Anaheim, Egyesült ÁllamokNo longer taking part
- Annapolis Internal Medicine/CCT ResearchAnnapolis, Egyesült ÁllamokNo longer taking part
- Advanced Clinical Research of AtlantaAtlanta, Egyesült ÁllamokNo longer taking part
- Access Research InstituteBrooksville, Egyesült ÁllamokNo longer taking part
- PanAmerican Clinical Research LLCBrownsville, Egyesült ÁllamokNo longer taking part
- ClinSearchChattanooga, Egyesült ÁllamokNo longer taking part
- Centricity ResearchColumbus, Egyesült ÁllamokNo longer taking part
- Nature Coast Clinical ReasearchCrystal River, Egyesült ÁllamokNo longer taking part
- JY Research Institute IncCutler Bay, Egyesült ÁllamokNo longer taking part
- DeLand, FloridaHospital not named in the registryNo longer taking part
- Altoona Center For Clinical ResearchDuncansville, Egyesült ÁllamokNo longer taking part
- Medical Care/CCTElizabethton, Egyesült ÁllamokNo longer taking part
- DelRicht Research of GulfportGulfport, Egyesült ÁllamokNo longer taking part
- Jacksonville Center for Clinical ResearchJacksonville, Egyesült ÁllamokNo longer taking part
- Santa Rosa Medical CenterLas Vegas, Egyesült ÁllamokNo longer taking part
- A & D Doctor CenterMiami, Egyesült ÁllamokNo longer taking part
- Bioclinical Research AllianceMiami, Egyesült ÁllamokNo longer taking part
- Century Research LLCMiami, Egyesült ÁllamokNo longer taking part
- Cordova Research InstituteMiami, Egyesült ÁllamokNo longer taking part
- ITB ResearchMiami, Egyesült ÁllamokNo longer taking part
- AMRNew Orleans, Egyesült ÁllamokNo longer taking part
- Delricht ResearchNew Orleans, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research, LLCNewton, Egyesült ÁllamokNo longer taking part
- Quality Clinical Research, Inc.Omaha, Egyesült ÁllamokNo longer taking part
- Combined Research Orlando Phase I-IVOrlando, Egyesült ÁllamokNo longer taking part
- New Horizons ResearchPalmetto Bay, Egyesült ÁllamokNo longer taking part
- Center for Clinical Trials of SacramentoSacramento, Egyesült ÁllamokNo longer taking part
- Onsite Clinical SolutionsSalisbury, Egyesült ÁllamokNo longer taking part
- Quality Research IncSan Antonio, Egyesült ÁllamokNo longer taking part
- Worldwide Clinical TrialsSan Antonio, Egyesült ÁllamokNo longer taking part
- Inspire Santa Fe Medical GroupSanta Fe, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty ResearchTempe, Egyesült ÁllamokNo longer taking part
- Tucson Neuroscience Research, LLCTucson, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Atom Therapeutics Co., Ltd
- Azonosító
- NCT06276556
- A regiszteradat frissítve
- 2025. július 16.
- Eredeti leírás
The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).A teljes eredeti leírásKevesebb
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
The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).
Bevonási feltételek: Must have completed the double-blind Treatment Period in Study ABP-671-301 (Part 1 or Part 2) and are actively receiving and tolerating the study drug up to the Week 28 visit in Study ABP-671-301.
Kizáró feltételek: Is planning to become pregnant or breastfeed during the study or within ≤30 days after the last dose of the study drug; Has a new medical or psychological condition that, in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the participant, interfere with the participant's ability to comply with the protocol requirements to complete the Extension Study, or potentially compromise the results or interpretation of the Extension Study; Is intolerant or unwilling to take colchicine or naproxen.