Clinical trial NCT04130204: Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)
Official title: Randomized, Double-blinded, Placebo-controlled Study of the Efficacy and Safety of DYV700 for Reducing Pain Associated With an Acute Gout Flare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Lead sponsor: Dyve Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-17
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blind
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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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Primary outcomes:
measure: Pain Intensity in the Target Joint
timeFrame: Baseline-7 days
Secondary outcomes:
measure: Time to Resolution
timeFrame: Baseline-7 days
measure: Rescue Medication Usage
timeFrame: Baseline-7 days
measure: Swelling
timeFrame: 24 hours and 7 days
measure: Tenderness
timeFrame: 24 hours and 7 days
measure: PROMIS PF 20
timeFrame: Baseline (prior to product application and colchicine use), day 2 and day 7
measure: Level of Improvement
timeFrame: 24 hours, day 2 and day 7
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Baseline-7 days
Locations:
city: Poway
country: United States
facility: Smitha Reddy
state: California
Study officials:
References: