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

Gout Clinical Trial

— TARGETS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130204
• Other study ID #: DYV-702
• Status: Completed
• Phase: Phase 2
• Start date: February 12, 2020
• Est. completion date: May 21, 2021

Study information

• Verified date: May 2022
• Source: Dyve Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: May 21, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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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Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• DYV700
Proprietary transdermal delivery platform
• Placebo
Vehicle transdermal delivery platform
• 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.

Locations

Country	Name	City	State
United States	Smitha Reddy	Poway	California

Sponsors (1)

Lead Sponsor	Collaborator
Dyve Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Adverse event and serious adverse event incidence during trial period	Baseline-7 days
Primary	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	Time to Resolution	Time to resolution (with resolution defined as a = 50% reduction in target joint pain score from baseline)	Baseline-7 days
Secondary	Rescue Medication Usage	Usage of rescue medications for pain throughout treatment period	Baseline-7 days
Secondary	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
Secondary	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
Secondary	PROMIS PF 20	Physical Function Questionnaire	Baseline (prior to product application and colchicine use), day 2 and day 7
Secondary	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