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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05256810
Other study ID # ALN-XDH-001
Secondary ID 2021-005773-68
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date February 25, 2022
Est. completion date January 25, 2023

Study information

Verified date March 2024
Source Alnylam Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 44
Est. completion date January 25, 2023
Est. primary completion date January 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
ALN-XDH
ALN-XDH administered by SC injection
Placebo
Placebo administered by SC injection

Locations

Country Name City State
United Kingdom Clinical Trial Site London

Sponsors (1)

Lead Sponsor Collaborator
Alnylam Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: Frequency of Adverse Events Up to 10 months
Primary Parts B and C: Frequency of Adverse Events Up to 14 months
Primary Parts B and C: Percentage of Participants with Serum Uric Acid (sUA) <6 mg/dL Up to 12.25 months
Secondary 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
Secondary Part A: Maximum Plasma Concentration (Cmax) for ALN-XDH and Potential Metabolites Day 1 predose and up to 48 hours postdose
Secondary Part A: Time to Maximum Plasma Concentration (tmax) for ALN-XDH and Potential Metabolites Day 1 predose and up to 48 hours postdose
Secondary Part A: Fractional Excreted in Urine (fe) for ALN-XDH and Potential Metabolites Day 1 predose and up to 24 hours postdose
Secondary Part A: Percent Change from Baseline in sUA Baseline through Month 9
Secondary Parts B and C: Percentage of Participants with sUA <5 mg/dL Up to 12.25 months
Secondary Parts B and C: Percentage Change from Baseline in sUA Level Up to 12.25 months
Secondary 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
Secondary Parts B and C: Frequency of Treatment-associated Gout Flares Treatment-associated gout flares are defined as gout flares that occur within 6 months of study drug initiation. Up to 6 months
Secondary Parts B and C: Percent Change from Baseline in 24-hour Urine Uric Acid (uUA) Baseline through Month 6
Secondary Parts B and C: Percent Change from Baseline in Serum Xanthine Baseline through Month 6
Secondary Parts B and C: Percent Change from Baseline in 24-hour Urine Xanthine Baseline through Month 6
Secondary Parts B and C: Percent Change from Baseline in Serum Hypoxanthine Baseline through Month 6
Secondary Parts B and C: Percent Change from Baseline in 24-hour Urine Hypoxanthine Baseline through Month 6
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