A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout (NCT05256810) | Clinical Trial Compass
TerminatedPhase 1/2
A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout
Stopped: The Sponsor elected not to continue with the study
United Kingdom44 participantsStarted 2022-02-25
Plain-language summary
The purpose of this study is to:
* Part A: Evaluate the safety and tolerability of single ascending doses of ALN-XDH in healthy adult participants
* Part B: Evaluate the safety, tolerability and efficacy of ALN-XDH as monotherapy in adult patients with gout
* Part C: Evaluate the safety, tolerability and efficacy of ALN-XDH as add-on therapy in adult patients with gout
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Part A: has serum uric acid (sUA) level ≥4 mg/dL and ≤7 mg/dL
* Parts B and C: meets the American College of Rheumatology criteria for acute arthritis of primary gout
* Part B: has an sUA level ≥8 mg/dL while not receiving urate-lowering therapy (ULT) or following a 1-week washout period of prior ULT
* Part C: has been on a stable dose of allopurinol for gout for ≥6 weeks prior to screening
* Part C: has an sUA level ≥6 mg/dL
Exclusion Criteria:
* Parts A, B and C: Has received an investigational agent within the last 30 days
* Parts A, B and C: Has experienced or is being treated for acute gout flare(s) within 14 days prior to randomization
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Frequency of Adverse Events
Timeframe: Up to 10 months
2
Parts B and C: Frequency of Adverse Events
Timeframe: Up to 14 months
3
Parts B and C: Percentage of Participants with Serum Uric Acid (sUA) <6 mg/dL