Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout

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Description

D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.

Targeted Conditions

Study Overview

Start Date
April 17, 2023
Completion Date
December 30, 2024
Enrollment
80
Date Posted
December 27, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Study Center
Birmingham, Alabama 35233, United States

Study Center
Panorama City, California 91402, United States

Study Center
Evergreen Park, Illinois 60805, United States

Study Center
Brownsburg, Indiana 46254, United States

Study Center
Charlotte, North Carolina 28209, United States

Study Center
Hickory, North Carolina 28601, United States

Study Center
Rocky Mount, North Carolina 27804, United States

Study Center
Salisbury, North Carolina 28144, United States

Study Center
Wilmington, North Carolina 28401, United States

Study Center
Winston-Salem, North Carolina 27103, United States

Study Center
Duncansville, Pennsylvania 16635, United States

Study Center
Scottdale, Pennsylvania 15683, United States

Study Center
Bristol, Tennessee 37620, United States

Study Center
Knoxville, Tennessee 37909, United States

Study Center
San Antonio, Texas 78215, United States

Study Center
Morgantown, West Virginia 26505, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
75
Eligibility Criteria
Inclusion Criteria:

Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response
Subject has had at least 2 gout flares in the previous 12 months.
Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive).
Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug.
Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator

Exclusion Criteria:

Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
Women who are pregnant or breastfeeding

Study Contact Info

Study Contact Name
Kathryn Stazzone
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
NCTid (if applicable)
NCT05665699