Overview

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

Status:
Recruiting
Trial end date:
2021-04-01
Target enrollment:
0
Participant gender:
All
Summary
This overall goal of this trial will be to demonstrate that DYV700 is safe and effective as a treatment for acute gout flares.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dyve Biosciences, Inc.
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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