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Trial record 1 of 1 for:    NCT05256810
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A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout

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ClinicalTrials.gov Identifier: NCT05256810
Recruitment Status : Recruiting
First Posted : February 25, 2022
Last Update Posted : June 3, 2022
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Gout Drug: ALN-XDH Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Part A: ALN-XDH
A single dose of ALN-XDH administered by subcutaneous (SC) injection.
Drug: ALN-XDH
ALN-XDH administered by SC injection

Placebo Comparator: Part A: Placebo
A single dose of placebo administered by SC injection.
Drug: Placebo
Placebo administered by SC injection

Experimental: Part B: ALN-XDH Single Dose
A single dose of ALN-XDH administered by SC injection.
Drug: ALN-XDH
ALN-XDH administered by SC injection

Experimental: Part B: ALN-XDH Multiple Dose
Multiple doses of ALN-XDH administered by SC injection.
Drug: ALN-XDH
ALN-XDH administered by SC injection

Placebo Comparator: Part B: Placebo
Multiple doses of placebo administered by SC injection.
Drug: Placebo
Placebo administered by SC injection

Experimental: Part C: ALN-XDH
A single dose of ALN-XDH administered by SC injection.
Drug: ALN-XDH
ALN-XDH administered by SC injection

Placebo Comparator: Part C: Placebo
A single dose of placebo administered by SC injection.
Drug: Placebo
Placebo administered by SC injection




Primary Outcome Measures :
  1. Part A: Frequency of Adverse Events [ Time Frame: Up to 10 months ]
  2. Parts B and C: Frequency of Adverse Events [ Time Frame: Up to 14 months ]
  3. Parts B and C: Percentage of Participants with Serum Uric Acid (sUA) <6 mg/dL [ Time Frame: Up to 12.25 months ]

Secondary Outcome Measures :
  1. Part A: Area Under the Plasma Concentration-time Curve (AUC) for ALN-HSD and Potential Metabolites [ Time Frame: Day 1 predose and up to 48 hours postdose ]
  2. Part A: Maximum Plasma Concentration (Cmax) for ALN-XDH and Potential Metabolites [ Time Frame: Day 1 predose and up to 48 hours postdose ]
  3. 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 ]
  4. Part A: Fractional Excreted in Urine (fe) for ALN-XDH and Potential Metabolites [ Time Frame: Day 1 predose and up to 24 hours postdose ]
  5. Part A: Percent Change from Baseline in sUA [ Time Frame: Baseline through Month 9 ]
  6. Parts B and C: Percentage of Participants with sUA <5 mg/dL [ Time Frame: Up to 12.25 months ]
  7. Parts B and C: Percentage Change from Baseline in sUA Level [ Time Frame: Up to 12.25 months ]
  8. Parts B and C: Plasma Concentrations of ALN-XDH and Potential Major Metabolite(s) [ Time Frame: Day 1 and Day 85 predose and up to 4 hours postdose ]
  9. Parts B and C: Frequency of Treatment-associated Gout Flares [ Time Frame: Up to 6 months ]
    Treatment-associated gout flares are defined as gout flares that occur within 6 months of study drug initiation.

  10. Parts B and C: Percent Change from Baseline in 24-hour Urine Uric Acid (uUA) [ Time Frame: Baseline through Month 6 ]
  11. Parts B and C: Percent Change from Baseline in Serum Xanthine [ Time Frame: Baseline through Month 6 ]
  12. Parts B and C: Percent Change from Baseline in 24-hour Urine Xanthine [ Time Frame: Baseline through Month 6 ]
  13. Parts B and C: Percent Change from Baseline in Serum Hypoxanthine [ Time Frame: Baseline through Month 6 ]
  14. Parts B and C: Percent Change from Baseline in 24-hour Urine Hypoxanthine [ Time Frame: Baseline through Month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 al lopurinol 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05256810


Contacts
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Contact: Alnylam Clinical Trial Information Line 1-877-ALNYLAM clinicaltrials@alnylam.com
Contact: Alnylam Clinical Trial Information Line 1-877-256-9526 clinicaltrials@alnylam.com

Locations
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United Kingdom
Clinical Trial Site Recruiting
London, United Kingdom
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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Study Director: Medical Director Alnylam Pharmaceuticals
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Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05256810    
Other Study ID Numbers: ALN-XDH-001
2021-005773-68 ( EudraCT Number )
First Posted: February 25, 2022    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alnylam Pharmaceuticals:
Serum uric acid
siRNA
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases