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Dyve Biosciences - DYV-702 - Clinical Research Study

A randomized, double-blinded, placebo-controlled study of the efficacy and safety of DYV700 for reducing pain associated with acute gout flares.

Dyve Biosciences - DYV-702 - Clinical Research Study

Age Maximum

75

Eighteen Years Old to Seventy-Five Years Old

Diagnosis

Gout

Acute Gout Flare

PLACEBO CONTROLLED

YES

Possible Placebo

DURATION

7 Days

Final study visit is 7 days after a qualifying gout flare

STIPEND

$50

$50 Per Visit, $565 Max

Patient Benefits

Patients who screen and then enroll in the study will receive:

  • Doctor Assessements
  • Lab work and Safety Follow-ups
  • Study drug (active, comparator or placebo)
  • $50.00 per completed study visit ($565 Maximum for the course of the study.)

Study Duration

Study Duration for Patients

The total study duration is approximately 73-weeks which consists of approximately 29 visits during the course of the study.

The study consists of three periods:

  1. Screening Period (2 to 5 weeks before the treatment starts) to see if you are eligible to participate in the study.
  2. Study Treatment Period (24 Hours After Flare). This Study’s Treatment period is a Double-Blind Study Treatment Period within 24 hours after a reported gout flare.
  3. Safety Follow-Up Visit (SFU visit) 7 days after the reported flare.

The study may also have some unplanned visits, most commonly for repeat lab work.

Study Drug

DVY700

DYV700 is an investigational transdermal delivery lotion.

Study Location

600 Aviator Ct.
Vandalia, OH 45377

Inclusion Criteria

The following must be met in order to qualify for the study.

  •  Females and males, age 18 to 75 years of age.
  • Diagnosis of gout
  • Subjects must have experienced more than 1 gout flare in the 12 months prior to screening
  • Subjects must have at least 3 of the 4 listed:
    a. Presence of a self-reported gout flare
    b. Pain at rest score > 3 on a 0-10 point numerical scale
    c. Presence of at least one swollen joint
    d. Presence of at least one warm joint

Exclusion Criteria

Patients with any of the following are ineligible to enroll in the study.

  • BMI of >40kg/m2 at the time of screening
  • 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 more than 2 gout flares per month, or >12 attacks overall in the 6 months prior to randomization.
  • Subjects with a history of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting within the previous 6 months prior to screening.
  • History of congestive heart failure in the past 12 months
  • Subjects with malignancies that are currently active with exception of non-melanoma skin cancer that is not in the area to be treated.
  • Received an injection of corticosteroids into the target joint for gout pain in the last 6 months.
  • Diagnosis of Stage 4 or 5 Chronic Kidney Disease (CKD)
  • Uncontrolled hypertension>170/95mmHg and/or sodium sensitivity.
  • Labile diabetics (poorly controlled with frequent swings to hypo and hyperglycemia) who in the investigator’s opinion may not be appropriate study candidates.
  • Presence of an active systemic or local skin disease, open wounds or lesions, dermatitis, eczema or psoriasis in the area to be treated (limbs) during the screening visit or subject reported presence of an active systemic or local skin disease, open wounds or lesions, dermatitis, eczema or psoriasis in the area to be treated when they call into the call center upon initiation of symptoms of gout flair.
  • Subjects with neuropathy that would impair perception in the target joint’

** Other eligibility criteria exist to enroll in the study.   Study eligibility requirements are subject to change.  STAT Research and Dr. Wolfe reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at anytime without prior notice.

How to contact us...

1-833-STAT-833

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