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

Primary Purpose

Gout

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
D-0120
Allopurinol
Sponsored by
InventisBio Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response Subject has reported at least 2 gout flares in the previous 12 months. Body Mass Index (BMI) between 18.0 and 40.0 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

Sites / Locations

  • Study CenterRecruiting
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  • DallasRecruiting
  • Study CenterRecruiting
  • Study CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A

Cohort B

Arm Description

week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol

week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol

Outcomes

Primary Outcome Measures

• To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12

Secondary Outcome Measures

Full Information

First Posted
December 19, 2022
Last Updated
August 17, 2023
Sponsor
InventisBio Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05665699
Brief Title
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout
Official Title
A Randomized, Open-Label, Multiple-Dose Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
January 23, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InventisBio Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized , Open Label, Multiple Dose
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Description
week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol
Intervention Type
Drug
Intervention Name(s)
D-0120
Intervention Description
increasing dose of D-0120
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
standard dosing
Primary Outcome Measure Information:
Title
• To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response Subject has reported at least 2 gout flares in the previous 12 months. Body Mass Index (BMI) between 18.0 and 40.0 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Stazzone
Phone
3025195966
Email
kathryn.stazzone@inventisbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Stazzone
Organizational Affiliation
InventisBio Co., Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Study Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Name
Study Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com
Facility Name
Study Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn M Stazzone
Phone
302-519-5966
Email
kathryn.stazzone@inventisbio.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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