GoutPhase 2TARGETSNCT04130204
Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)
A Phase 2 study testing DYV700 and Colchicine 0.6 mg in people with Gout, run by Dyve Biosciences, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout
- What is being tested?
- DYV700 and Colchicine 0.6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 21 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gout
- Being tested
- DYV700, Placebo, Colchicine 0.6 mg
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DYV700Drug
Proprietary transdermal delivery platform
PlaceboDrug
Vehicle transdermal delivery platform
Colchicine 0.6 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Placebo; Drug: Colchicine 0.6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline-7 days
Secondary outcomes (6)
Time to Resolution
Time to resolution (with resolution defined as a ≥ 50% reduction in target joint pain score from baseline)
Measured: Baseline-7 days
Rescue Medication Usage
Usage of rescue medications for pain throughout treatment period
Measured: 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)
Measured: 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"
Measured: 24 hours and 7 days
PROMIS PF 20
Physical Function Questionnaire
Measured: 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
Measured: 24 hours, day 2 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start12 Feb 2020
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dyve Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130204
- Sponsor's protocol ID
- DYV-702
- Acronym
- TARGETS
- Status last verified
- May 2022
- First submitted
- 15 Oct 2019
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blinded, Placebo-controlled Study of the Efficacy and Safety of DYV700 for Reducing Pain Associated With an Acute Gout Flare
- ClinicalTrials.gov ID
- NCT04130204
- Acronym / sponsor ID
- TARGETS / DYV-702
- Conditions
- Gout
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Dyve Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: DYV700, Drug: Colchicine 0.6 mgDYV700, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC) |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Colchicine 0.6 mgPlacebo, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DYV700Proprietary transdermal delivery platform | Drug | Active |
| PlaceboVehicle transdermal delivery platform | Drug | Placebo |
| Colchicine 0.6 mgStandard 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 | Active, Placebo |
Primary outcome
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
6 secondary outcomes
Time to Resolution
Time frame: Baseline-7 days
Rescue Medication Usage
Time frame: Baseline-7 days
Swelling
Time frame: 24 hours and 7 days
Tenderness
Time frame: 24 hours and 7 days
PROMIS PF 20
Time frame: Baseline (prior to product application and colchicine use), day 2 and day 7
Level of Improvement
Time frame: 24 hours, day 2 and day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DYV700 and Colchicine 0.6 mg in people with Gout, run by Dyve Biosciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity in the Target Joint (time frame: Baseline-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.