Phase 2 Gout Trial, Recruiting NCT07280156 Sponsor: Protalix Condition: Gout
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Phase 2 Gout Trial, Recruiting

NCT07280156
Recruiting Phase 2

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 18 years of age or older
  • Your weight is between 50 kg (about 110 lbs) and 150 kg (about 330 lbs)
  • You have gout and your uric acid levels have not been brought under control with standard medications, or you are unable to take those medications
  • You are willing to stop taking any current oral uric acid-lowering treatment during the study
  • If you are female, you are either unable to have children naturally, have gone through menopause, or are not pregnant and are using a reliable form of birth control

Who may not be able to join:

  • You have any condition that causes joint inflammation or arthritis as part of its symptoms
  • You have tested positive for hepatitis B, hepatitis C, or HIV
  • You are pregnant, breastfeeding, or planning to become pregnant during the study
  • You have a known allergy or sensitivity to injected protein-based medicines, including PEGylated products (confirm with trial site)
  • You have previously received any uricase-based treatment, whether as part of a study or as a standard medicine
  • You are currently taking any medication known to affect uric acid levels in the body
  • You have a history of severe allergic reactions, anaphylaxis, or severe allergies
  • You have a condition called G6PD deficiency or catalase deficiency
  • You have had a significant blood disorder or autoimmune condition in the past 5 years, or your immune system is weakened or suppressed by medication
  • You have serious or poorly controlled heart failure, an uncontrolled irregular heartbeat, a recent heart attack or unstable chest pain, or uncontrolled high blood pressure at the time of screening
  • You currently have liver disease, or your liver enzyme levels are above the normal range at screening
  • You have a chronic (long-term) liver condition
  • Your blood counts for red blood cells, white blood cells, or platelets are below certain minimum levels (confirm with trial site)
  • You have a known severe lung condition such as pulmonary fibrosis, bronchiectasis, or interstitial pneumonitis
  • Your kidney function is significantly reduced, or you have had a kidney transplant, or you require dialysis
  • You are unable to tolerate or have a medical reason not to take a medication called methotrexate
  • You have poorly controlled type 2 diabetes, or you have type 1 diabetes
  • You have a condition called latent autoimmune diabetes of adults (LADA)
  • Your immune system is weakened for any reason
  • You have been treated for or diagnosed with cancer in the past 5 years, with the exception of certain minor skin cancers

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 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +972-4-902-8100

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 2
Sponsor
Protalix
Registry
ClinicalTrials.gov
Start date
22 December 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇬🇪 Georgia 🇮🇱 Israel 🇺🇸 United States

Primary endpoints

Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

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