Back to resultsTopical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS) (TARGETS)
Primary Purpose
Gout
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DYV700
Placebo
Colchicine 0.6 mg
Sponsored by
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.
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Sites / Locations
- Smitha Reddy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
DYV700, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)
Placebo, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to Resolution
Time to resolution (with resolution defined as a ≥ 50% reduction in target joint pain score from baseline)
Rescue Medication Usage
Usage of rescue medications for pain throughout treatment period
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)
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"
PROMIS PF 20
Physical Function Questionnaire
Level of Improvement
Subject Reported Assessment of Improvement Likert Scale 0= excellent, 1= very good, 2= good, 3= fair, 4= poor response to treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04130204
Brief Title
Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
May 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dyve Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo-controlled, double-blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Topical lotion is provided in de-identified sachets
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
DYV700, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)
Intervention Type
Drug
Intervention Name(s)
DYV700
Intervention Description
Proprietary transdermal delivery platform
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle transdermal delivery platform
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.6 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity in the Target Joint
Description
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
Time Frame
Baseline-7 days
Secondary Outcome Measure Information:
Title
Time to Resolution
Description
Time to resolution (with resolution defined as a ≥ 50% reduction in target joint pain score from baseline)
Time Frame
Baseline-7 days
Title
Rescue Medication Usage
Description
Usage of rescue medications for pain throughout treatment period
Time Frame
Baseline-7 days
Title
Swelling
Description
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)
Time Frame
24 hours and 7 days
Title
Tenderness
Description
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"
Time Frame
24 hours and 7 days
Title
PROMIS PF 20
Description
Physical Function Questionnaire
Time Frame
Baseline (prior to product application and colchicine use), day 2 and day 7
Title
Level of Improvement
Description
Subject Reported Assessment of Improvement Likert Scale 0= excellent, 1= very good, 2= good, 3= fair, 4= poor response to treatment
Time Frame
24 hours, day 2 and day 7
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Adverse event and serious adverse event incidence during trial period
Time Frame
Baseline-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
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.
Key Exclusion Criteria:
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.
-
Facility Information:
Facility Name
Smitha Reddy
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)
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