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

Alnylam Pharmaceuticals

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Gout

Treatments: Drug: Placebo; Drug: ALN-XDH

Study type: Interventional

Funder types: Industry

Identifiers

NCT05256810

2021-005773-68 (EudraCT Number)

ALN-XDH-001

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 7 patient groups, including a placebo group

Part A: ALN-XDH

Experimental group

Description:

A single dose of ALN-XDH administered by subcutaneous (SC) injection.

Treatment:

Drug: ALN-XDH

Part A: Placebo

Placebo Comparator group

Description:

A single dose of placebo administered by SC injection.

Treatment:

Drug: Placebo

Part B: ALN-XDH Single Dose

Experimental group

Description:

A single dose of ALN-XDH administered by SC injection.

Treatment:

Drug: ALN-XDH

Part B: ALN-XDH Multiple Dose

Experimental group

Description:

Multiple doses of ALN-XDH administered by SC injection.

Treatment:

Drug: ALN-XDH

Part B: Placebo

Placebo Comparator group

Description:

Multiple doses of placebo administered by SC injection.

Treatment:

Drug: Placebo

Part C: ALN-XDH

Experimental group

Description:

A single dose of ALN-XDH administered by SC injection.

Treatment:

Drug: ALN-XDH

Part C: Placebo

Placebo Comparator group

Description:

A single dose of placebo administered by SC injection.

Treatment:

Drug: Placebo