Phase 4 Gout Trial, Recruiting NCT07346079 Sponsor: Massachusetts General Hospital Condition: Gout
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Phase 4 Gout Trial, Recruiting

NCT07346079
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing and able to sign a consent form agreeing to take part in the study
  • You are a man or woman between 18 and 85 years old
  • You have been diagnosed with gout according to recognised medical guidelines (confirm with trial site)
  • Your current gout flare (painful episode) started within the last 5 days before joining the study
  • Your body mass index (a measure of weight relative to height) is 45 or below
  • Your pain level at the start of the study is at least 50 out of 100 on a pain rating scale
  • You have had at least one other gout flare in the past 12 months
  • You are unable to take the standard gout medications (NSAIDs and colchicine) because they have not worked for you, caused you problems, or your doctor considers them unsuitable or unsafe for you
  • You are willing and able to use a mobile phone or electronic device to complete surveys during the study

Who may not be able to join:

  • You have certain other health conditions, including scleroderma, osteoporosis, active or recurring infections, cold sores in the eye, a history of stomach ulcers, uncontrolled heart failure, uncontrolled high blood pressure, uncontrolled diabetes (type 1 or 2), recent surgery within the past 2 weeks, or an allergy to products derived from pigs
  • You have a condition affecting your adrenal glands (the glands that produce stress hormones) (confirm with trial site)
  • You have rheumatoid arthritis, a joint infection, or another type of active inflammatory joint condition
  • Your current gout flare affects more than 4 joints at the same time
  • You have taken part in another clinical trial within the last 30 days, or have recently taken an experimental drug (confirm with trial site for specific timing)
  • You have previously been part of this same study
  • You have severely reduced kidney function (confirm with trial site)
  • You have another serious uncontrolled condition affecting your blood, brain, liver, lungs, digestive system, or hormone levels, as judged by the study doctor
  • The study doctor believes your health or circumstances could put you at risk or prevent you from completing the study
  • You have ever used, or are currently using, any ACTH medicine (a type of hormone treatment) (confirm with trial site)
  • You are pregnant or breastfeeding; women who could become pregnant must be using an acceptable form of contraception
  • You are taking urate-lowering medication (to reduce uric acid) but have not been on a stable dose for at least 2 weeks before joining the study
  • You have recently taken certain pain relief medicines or biological treatments, including steroids, strong painkillers, paracetamol, anti-inflammatory drugs, colchicine, or certain immune-system medicines, within specific time periods before joining (confirm with trial site for exact timeframes)
  • You have received a vaccine within the 30 days before joining the study, or plan to receive one during the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Hyon K Choi, MD, DrPH, Massachusetts General Hospital

Phone: 617-643-2140

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
20 December 2025
Est. completion
31 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in gout pain intensity from baseline in target join to 72 hours post-injection

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov