## Protocol Section
### Identification Module
**NCT ID:** NCT06414837

**Brief Title:** Clinical Trial of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

**Official Title:** Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

#### Organization Study ID Info
**ID:** HR091506-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Jiangsu HengRui Medicine Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Jiangsu HengRui Medicine Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.

### Conditions Module

**Conditions:**

- Gout With Hyperuricemia in Adults

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 434

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: HR091506 tablets + placebo of febuxostat tablets

**Label:** Treatment group A: HR091506 tablets + placebo of febuxostat tablets

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: febuxostat tablets + placebo of HR091506 tablets

**Label:** Treatment group B: febuxostat tablets + placebo of HR091506 tablets

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment group A: HR091506 tablets + placebo of febuxostat tablets

**Description:** HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd, from Week 1 to 36.

**Name:** HR091506 tablets + placebo of febuxostat tablets

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Treatment group B: febuxostat tablets + placebo of HR091506 tablets

**Description:** febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd . from Week 1 to 36.

**Name:** febuxostat tablets + placebo of HR091506 tablets

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The proportion of subjects with serum uric acid level < 300 μmoL/L at Week 36

**Time Frame:** Week 36

#### Secondary Outcomes

**Measure:** Proportion of subjects with serum uric acid level < 360 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration

**Time Frame:** at week 4,8,12,16,20,24,28,32,36 after administration

**Measure:** Proportion of subjects with serum uric acid level < 300 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration

**Time Frame:** at week 4,8,12,16,20,24,28,32,36 after administration

**Measure:** Change of serum uric acid level from baseline week 4,8,12,16,20,24,28,32,36 after administration

**Time Frame:** week 4,8,12,16,20,24,28,32,36 after administration

**Measure:** Proportion of subjects with ≥1 gout flare during the 36 weeks treatment stage

**Time Frame:** during the 36 weeks treatment stage

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. 18-75 years old, male or female;
2. Meet the 2015 ACR/EULAR gout classification criteria;
3. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
4. Patients with tophi, chronic arthropathy, frequent attacks;
5. Willing to ues contraceptive measures during the study;
6. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. History of acute gout attack within 4 weeks before randomization.
2. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
3. Subjects with major cardiovascular disease within 6 months before randomization.
4. History of chronic infection or recurrent infection within 1year before randomization.
5. History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
6. History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
7. Subjects with poorly controlled blood pressure or diabetes mellitus.
8. History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.
9. History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.
10. Abnormal laboratory tests that may affect subjects participating in the research.
11. Combined use of prohibited drugs.
12. Allergic to ingredient or component of the experimental drug.
13. Participated in other clinical trials within 1 month before randomization.
14. Pregnant or nursing women.
15. History of drug abuse, drug use and/or excessive drinking within 1 year before screening.
16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ninghui.yan@hengrui.com

**Name:** Ninghui Yan

**Phone:** +0518-82342973

**Role:** CONTACT

**Contact 2:**

**Email:** jing.xu.jx23@hengrui.com

**Name:** Jing Xu

**Phone:** +0518-82342973

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000070657

- Term: Crystal Arthropathies

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000011686

- Term: Purine-Pyrimidine Metabolism, Inborn Errors

- ID: D000008661

- Term: Metabolism, Inborn Errors

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M24343

- Name: Hyperuricemia

- Relevance: HIGH

- As Found: Hyperuricemia

- ID: M9177

- Name: Gout

- Relevance: HIGH

- As Found: Gout

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M630

- Name: Crystal Arthropathies

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11641

- Name: Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: M14540

- Name: Purine-Pyrimidine Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006073

- Term: Gout

- ID: D000033461

- Term: Hyperuricemia

### Intervention Browse Module - Ancestors

- ID: D000006074

- Term: Gout Suppressants

- ID: D000018501

- Term: Antirheumatic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M434

- Name: Febuxostat

- Relevance: HIGH

- As Found: Mobile Health

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069465

- Term: Febuxostat

### Misc Info Module

- Version Holder: 2024-05-31
