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

NCT ID: NCT04130204

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2021-05-21

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.

Conditions

Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

DYV700, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)

Group Type: EXPERIMENTAL

DYV700

Intervention Type: DRUG

Proprietary transdermal delivery platform

Colchicine 0.6 mg

Intervention Type: DRUG

Standard of care, 2 tablets (1.2 mg) loading dose followed by 1 tablet (0.6 mg) 1 hour later at onset of gout flare.

Placebo

Placebo, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vehicle transdermal delivery platform

Colchicine 0.6 mg

Intervention Type: DRUG

Standard of care, 2 tablets (1.2 mg) loading dose followed by 1 tablet (0.6 mg) 1 hour later at onset of gout flare.

Interventions

DYV700

Proprietary transdermal delivery platform

Intervention Type: DRUG

Placebo

Vehicle transdermal delivery platform

Intervention Type: DRUG

Colchicine 0.6 mg

Standard of care, 2 tablets (1.2 mg) loading dose followed by 1 tablet (0.6 mg) 1 hour later at onset of gout flare.

Intervention Type: DRUG

Eligibility Criteria

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.

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dyve Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Smitha Reddy

Poway, California, United States

Countries

United States

Other Identifiers

DYV-702

Identifier Type: -

Identifier Source: org_study_id