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

Phase 2TerminatedNCT05256810

Alnylam Pharmaceuticals44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gout

Interventions

ALN-XDHDRUG

ALN-XDH administered by SC injection

PlaceboDRUG

Placebo administered by SC injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Site

London, United Kingdom

Outcomes

Primary Outcomes

Part A: Frequency of Adverse Events

Time frame: Up to 10 months

Parts B and C: Frequency of Adverse Events

Time frame: Up to 14 months

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

Time frame: Up to 12.25 months

Secondary Outcomes

Part A: Area Under the Plasma Concentration-time Curve (AUC) for ALN-XDH and Potential Metabolites

Time frame: Day 1 predose and up to 48 hours postdose

Part A: Maximum Plasma Concentration (Cmax) for ALN-XDH and Potential Metabolites

Time frame: Day 1 predose and up to 48 hours postdose

Part A: Time to Maximum Plasma Concentration (tmax) for ALN-XDH and Potential Metabolites

Time frame: Day 1 predose and up to 48 hours postdose

Part A: Fractional Excreted in Urine (fe) for ALN-XDH and Potential Metabolites

Time frame: Day 1 predose and up to 24 hours postdose

Part A: Percent Change from Baseline in sUA

Time frame: Baseline through Month 9

Parts B and C: Percentage of Participants with sUA <5 mg/dL

Time frame: Up to 12.25 months

Parts B and C: Percentage Change from Baseline in sUA Level

Time frame: Up to 12.25 months

Data from ClinicalTrials.gov

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