Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)
Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)
This overall goal of this trial will be to demonstrate that DYV700 is safe and effective as a
 treatment for acute gout flares.
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.
Key Inclusion Criteria:

 1. Females and males, age 18 to 75 years of age.

 2. Diagnosis of gout using ACR/EULAR criteria (must have a score of equal to or greater
 than 8)

 3. Subjects must have experienced ≥2 gout flares in the 12 months prior to screening;

 4. Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior
 to the start of the gout flare and who will remain on the same dose throughout the
 follow-up period of the trial.

 5. If taking NSAID, oral steroids, opioids, or other pain medications at standard doses
 (as stated on drug label) for pain unrelated to their gout flare, must be taking the
 same drug for at least 7 days prior to the gout flare and throughout the length of the
 trial.

 6. Women of childbearing potential are excluded. Women not considered of childbearing
 potential must have one of the following documented in their study medical history:

 1. Postmenopausal for at least 12 months prior to study;

 2. Without a uterus and/or both ovaries; or

 3. Bilateral tubal ligation at least six months prior to study enrollment.

 Key Exclusion Criteria:

 1. BMI of >40kg/m2 at the time of screening

 2. Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior
 to the start of the gout flare and who will remain on the same dose throughout the
 follow-up period of the trial.

 3. Subjects who are contraindicated for the use of colchicine or whom are unable to take
 the SOC dose of 1.2mg followed by 0.6mg an hour later.

 4. Subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of
 infectious/septic arthritis, acute polyarticular gout (4 or more joints), with
 arthritis due to any cause other than gout that may confound any study assessments per
 Investigator discretion.

 5. Subjects who have experienced >2 gout flares per month, or >12 attacks overall in the
 months prior to randomization.

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