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

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ClinicalTrials.gov Identifier: NCT04130204
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dyve Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Gout Drug: DYV700 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, double-blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Topical lotion is provided in de-identified sachets
Primary Purpose: Treatment
Official Title: Randomized, Double-blinded, Placebo-controlled Study of the Efficacy and Safety of DYV700 for Reducing Pain Associated With an Acute Gout Flare
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : February 12, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Active
DYV700
Drug: DYV700
Topical Transdermal Delivery Lotion with Actives
Other Name: Active

Placebo Comparator: Placebo
Placebo
Other: Placebo
Topical Transdermal Delivery Lotion without Actives




Primary Outcome Measures :
  1. Pain Intensity in the Target Joint [ Time Frame: Baseline-7 days ]
    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 :
  1. Time to Resolution [ Time Frame: Baseline-7 days ]
    Time to resolution (with resolution defined as a ≥ 50% reduction in target joint pain score from baseline)

  2. Rescue Medication Usage [ Time Frame: Baseline-7 days ]
    Usage of rescue medications for pain throughout treatment period

  3. Swelling [ Time Frame: 24 hours and 7 days ]

    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)


  4. Tenderness [ Time Frame: 24 hours and 7 days ]
    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"

  5. PROMIS PF 20 [ Time Frame: Baseline (prior to product application and colchicine use), day 2 and day 7 ]
    Physical Function Questionnaire

  6. Level of Improvement [ Time Frame: 24 hours, day 2 and day 7 ]
    Subject Reported Assessment of Improvement Likert Scale 0= excellent, 1= very good, 2= good, 3= fair, 4= poor response to treatment


Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Baseline-7 days ]
    Adverse event and serious adverse event incidence during trial period



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130204


Contacts
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Contact: Ashley Seery 833-398-3246 ashley.seery@dyvebio.com

Locations
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United States, California
Smitha Reddy Recruiting
Poway, California, United States, 92064
Contact: Smitha Reddy, MD    858-312-1717    drreddy@acrmed.com   
Sponsors and Collaborators
Dyve Biosciences, Inc.
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Responsible Party: Dyve Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04130204    
Other Study ID Numbers: DYV-702
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases