Status:
COMPLETED
Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)
Lead Sponsor:
Dyve Biosciences, Inc.
Conditions:
Gout
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Key
- Females and males, age 18 to 75 years of age.
- Diagnosis of gout using ACR/EULAR criteria (must have a score of equal to or greater than 8)
- Subjects must have experienced ≥2 gout flares in the 12 months prior to screening;
- 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.
- 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.
- Women of childbearing potential are excluded. Women not considered of childbearing potential must have one of the following documented in their study medical history:
- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries; or
- Bilateral tubal ligation at least six months prior to study enrollment.
- Key
Exclusion
- BMI of \>40kg/m2 at the time of screening
- 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.
- 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.
- 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.
- Subjects who have experienced \>2 gout flares per month, or \>12 attacks overall in the months prior to randomization.
- \-
Key Trial Info
Start Date :
February 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2021
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT04130204
Start Date
February 12 2020
End Date
May 21 2021
Last Update
May 13 2022
Active Locations (1)
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1
Smitha Reddy
Poway, California, United States, 92064