NCT04130204

Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)

Randomized, Double-blinded, Placebo-controlled Study of the Efficacy and Safety of DYV700 for Reducing Pain Associated With an Acute Gout Flare

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Dyve Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This overall goal of this trial will be to demonstrate that DYV700 is safe and effective as a treatment for acute gout flares.

Detailed description

Gout presents as intermittent acute painful and debilitating gout flares. High serum uric acid levels lead to the deposition of urate crystals in and around the joints, most commonly the big toe (also called podagra) and other peripheral joints. An acute gout flare causes extreme pain and inflammation of the afflicted joints. It initially presents as a monoarticular condition but can affect several joints as the disease progresses. Gout flares typically take 7-10 days to resolve. Currently, the inflammation and pain associated with acute gout flares are treated anti-inflammatories, including non steroidal anti-inflammatory drugs (NSAIDs), colchicine, corticosteroids, and adrenocorticotropic hormone. However these drugs are limited in efficacy, contraindicated for some patients and may take more than 24 hours to relieve gout symptoms (e.g. colchicine). DYV700 will be developed to reduce the pain associated with acute gout flares. DYV700 is applied topically and utilizes a proprietary drug delivery system to deliver it's active ingredients.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	DYV700	Proprietary transdermal delivery platform
DRUG	Placebo	Vehicle transdermal delivery platform
DRUG	Colchicine 0.6 mg	Standard of care, 2 tablets (1.2 mg) loading dose followed by 1 tablet (0.6 mg) 1 hour later at onset of gout flare.

Timeline

• Start date: 2020-02-12
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2019-10-17
• Last updated: 2022-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study