A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout
- Registration Number
- NCT05256810
- Lead Sponsor
- Alnylam Pharmaceuticals
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part C: Placebo Placebo A single dose of placebo administered by SC injection. Part B: Placebo Placebo Multiple doses of placebo administered by SC injection. Part A: ALN-XDH ALN-XDH A single dose of ALN-XDH administered by subcutaneous (SC) injection. Part A: Placebo Placebo A single dose of placebo administered by SC injection. Part B: ALN-XDH Single Dose ALN-XDH A single dose of ALN-XDH administered by SC injection. Part B: ALN-XDH Multiple Dose ALN-XDH Multiple doses of ALN-XDH administered by SC injection. Part C: ALN-XDH ALN-XDH A single dose of ALN-XDH administered by SC injection.
- Primary Outcome Measures
Name Time Method Parts B and C: Frequency of Adverse Events Up to 14 months Parts B and C: Percentage of Participants with Serum Uric Acid (sUA) <6 mg/dL Up to 12.25 months Part A: Frequency of Adverse Events Up to 10 months
- Secondary Outcome Measures
Name Time Method Parts B and C: Percent Change from Baseline in 24-hour Urine Hypoxanthine Baseline through Month 6 Parts B and C: Percentage of Participants with sUA <5 mg/dL Up to 12.25 months Parts B and C: Percent Change from Baseline in 24-hour Urine Uric Acid (uUA) Baseline through Month 6 Parts B and C: Percent Change from Baseline in Serum Xanthine Baseline through Month 6 Part A: Percent Change from Baseline in sUA Baseline through Month 9 Part A: Area Under the Plasma Concentration-time Curve (AUC) for ALN-XDH and Potential Metabolites Day 1 predose and up to 48 hours postdose Part A: Time to Maximum Plasma Concentration (tmax) for ALN-XDH and Potential Metabolites Day 1 predose and up to 48 hours postdose Parts B and C: Frequency of Treatment-associated Gout Flares Up to 6 months Treatment-associated gout flares are defined as gout flares that occur within 6 months of study drug initiation.
Parts B and C: Percent Change from Baseline in 24-hour Urine Xanthine Baseline through Month 6 Part A: Fractional Excreted in Urine (fe) for ALN-XDH and Potential Metabolites Day 1 predose and up to 24 hours postdose Part A: Maximum Plasma Concentration (Cmax) for ALN-XDH and Potential Metabolites Day 1 predose and up to 48 hours postdose Parts B and C: Percentage Change from Baseline in sUA Level Up to 12.25 months Parts B and C: Plasma Concentrations of ALN-XDH and Potential Major Metabolite(s) Day 1 and Day 85 predose and up to 4 hours postdose Parts B and C: Percent Change from Baseline in Serum Hypoxanthine Baseline through Month 6
Trial Locations
- Locations (1)
Clinical Trial Site
🇬🇧London, United Kingdom