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

NCT04130204 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: DYV-702
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Pain Intensity in the Target Joint

  Sum of pain intensity differences (SPID) from baseline to Day 7 in the target joint, using a 11-point (0-10) numeric rating scale (NRS) pain scale with 0-No Pain and 10-The Most Intense Pain Imaginable

  Baseline-7 days

Secondary Outcomes (6)

• Time to Resolution

  Baseline-7 days

• Rescue Medication Usage

  Baseline-7 days

• Swelling

  24 hours and 7 days

• Tenderness

  24 hours and 7 days

• PROMIS PF 20

  Baseline (prior to product application and colchicine use), day 2 and day 7

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Baseline-7 days

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: DYV700; Drug: Colchicine 0.6 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Colchicine 0.6 mg

Interventions

DYV700 DRUG

Proprietary transdermal delivery platform

Active

Placebo DRUG

Vehicle transdermal delivery platform

Placebo

Colchicine 0.6 mg 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.

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dyve Biosciences, Inc.: lead

Study Sites (1)

Smitha Reddy

Poway, California, 92064, United States

Location

MeSH Terms

Conditions

Gout

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Topical lotion is provided in de-identified sachets
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blind

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: February 12, 2020
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)