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

Randomized, Double-blinded, Placebo-controlled Study of the Efficacy and Safety of DYV700 for Reducing Pain Associated With an Acute Gout Flare

This overall goal of this trial will be to demonstrate that DYV700 is safe and effective as a treatment for acute gout flares.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: DYV700; Drug: Colchicine 0.6 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Poway, California, United States, 92064
      • Smitha Reddy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: DYV700; Proprietary transdermal delivery platform; 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.
Placebo Comparator: 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)	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.; Drug: Placebo; Vehicle transdermal delivery platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Resolution	Time to resolution (with resolution defined as a ≥ 50% reduction in target joint pain score from baseline)	Baseline-7 days
Rescue Medication Usage	Usage of rescue medications for pain throughout treatment period	Baseline-7 days
Swelling	Swelling of the target joint as rated by a clinician using a Likert Scale 0- No swelling 1- mild swelling, 2- moderate swelling, 3- severe swelling (or bulging beyond joint margins)	24 hours and 7 days
Tenderness	Tenderness of the target joint as rated by a clinician using a Likert Scale 0= Patient States "no pain", 1= Patient states "there is pain and winces", 2= Patient states "there is pain, winces and withdraws"	24 hours and 7 days
PROMIS PF 20	Physical Function Questionnaire	Baseline (prior to product application and colchicine use), day 2 and day 7
Level of Improvement	Subject Reported Assessment of Improvement Likert Scale 0= excellent, 1= very good, 2= good, 3= fair, 4= poor response to treatment	24 hours, day 2 and day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Adverse event and serious adverse event incidence during trial period	Baseline-7 days

Collaborators and Investigators

• Sponsor: Dyve Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): May 21, 2021
• Study Completion (Actual): May 21, 2021

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: DYV-702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No