A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare

Treatment of Acute Gout Flare

The primary clinical activity outcome measurement will be: • Change from baseline in the subject-assessed pain intensity score (100-mm VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo.

The secondary clinical activity outcome measurements will be: • Change from baseline in the subject-assessed pain intensity score (100-mm VAS) in the target joint at 12, 24, 36, 48, and 60 hours post initial loading dose, and on Study Day 8 and Study Day 15, Subject-assessed PGART on Study Day 8, Change from baseline in the Investigator-assessed Target Joint Score (tenderness, swelling, erythema, warmth, and range of motion) at scheduled assessments through Study Day 15, Investigator-assessed IGART at scheduled assessments through Study Day 8, Proportion of subjects with a response (defined as a 20%, 50%, or 70% reduction from baseline without using Rescue Medication or Escape Medication) in the subject-assessed pain intensity score (100-mm VAS) in the target joint at 48 and 72 hours post initial loading dose, and on Study Day 8 and Study Day 15, Time to intake of medication taken for non-response, e.g., Rescue Medication and/or Escape Medication, from first IMP administration, Proportion and number of subjects with Rescue Medication or Escape Medication use from the first IMP administration up to 12 hours, >12 to 24 hours, >24 to 48 hours, >48 to 72 hours, >72 hours to Day 8, and >Day 8 to Day 15, Change from baseline in the subject-assessed QoL questionnaire (SF-12v2) at scheduled assessments through Study Day 15, Change from baseline in the subject-assessed pain intensity score (100-mm VAS) in any actively flaring non-target joint(s) on Study Day 4, Study Day 8, and Study Day 15.

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