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 range18 Years – 65 Years

SexALL

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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

What they're measuring

Part A: Frequency of Adverse Events

Timeframe: Up to 10 months

Parts B and C: Frequency of Adverse Events

Timeframe: Up to 14 months

Parts B and C: Percentage of Participants with Serum Uric Acid (sUA) <6 mg/dL

Timeframe: Up to 12.25 months

Trial details

NCT IDNCT05256810

SponsorAlnylam Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-25

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