Clinical trial NCT05665699: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Gout
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized , Open Label, Multiple Dose
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: • 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
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Study Center
state: Alabama
city: Plantation
country: United States
facility: Site Center
state: Florida
city: Evergreen Park
country: United States
facility: Study Center
state: Illinois
city: Brownsburg
country: United States
facility: Study Center
state: Indiana
city: Louisville
country: United States
facility: Site Center
state: Kentucky
city: Hickory
country: United States
facility: Study Center
state: North Carolina
city: Rocky Mount
country: United States
facility: Study Center
state: North Carolina
city: Salisbury
country: United States
facility: Study Center
state: North Carolina
city: Wilmington
country: United States
facility: Study Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Study Center
state: North Carolina
city: Scottdale
country: United States
facility: Study Center
state: Pennsylvania
city: Bristol
country: United States
facility: Study Center
state: Tennessee
city: Hendersonville
country: United States
facility: Site Center
state: Tennessee
city: Knoxville
country: United States
facility: Study Center
state: Tennessee
city: Fort Worth
country: United States
facility: Site Center
state: Texas
city: The Woodlands
country: United States
facility: Site Center
state: Texas
city: Richmond
country: United States
facility: Site Center
state: Virginia
city: Bellevue
country: United States
facility: Site Center
state: Washington
city: Morgantown
country: United States
facility: Study Center
state: West Virginia
Study officials:
affiliation: InventisBio Co., Ltd
name: Kathryn Stazzone
role: STUDY_DIRECTOR
References: