A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout

Gout Clinical Trial

Official title:

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Dose Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-XDH in Healthy Adult Subjects and Adult Patients With Gout

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
• 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
• 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

Related Conditions & MeSH terms

• Gout

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