A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout
NCT ID: NCT05256810
Last Updated: 2024-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
44 participants
INTERVENTIONAL
2022-02-25
2023-01-25
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A: ALN-XDH
A single dose of ALN-XDH administered by subcutaneous (SC) injection.
ALN-XDH
ALN-XDH administered by SC injection
Part A: Placebo
A single dose of placebo administered by SC injection.
Placebo
Placebo administered by SC injection
Part B: ALN-XDH Single Dose
A single dose of ALN-XDH administered by SC injection.
ALN-XDH
ALN-XDH administered by SC injection
Part B: ALN-XDH Multiple Dose
Multiple doses of ALN-XDH administered by SC injection.
ALN-XDH
ALN-XDH administered by SC injection
Part B: Placebo
Multiple doses of placebo administered by SC injection.
Placebo
Placebo administered by SC injection
Part C: ALN-XDH
A single dose of ALN-XDH administered by SC injection.
ALN-XDH
ALN-XDH administered by SC injection
Part C: Placebo
A single dose of placebo administered by SC injection.
Placebo
Placebo administered by SC injection
Interventions
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ALN-XDH
ALN-XDH administered by SC injection
Placebo
Placebo administered by SC injection
Eligibility Criteria
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Inclusion Criteria
* 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 experienced or is being treated for acute gout flare(s) within 14 days prior to randomization
18 Years
65 Years
ALL
Yes
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
London, , United Kingdom
Countries
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Other Identifiers
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2021-005773-68
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALN-XDH-001
Identifier Type: -
Identifier Source: org_study_id
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