A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)

NCT05936281 | Completed Phase 2

• 1 other identifier: GenSci 048-202
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering

Conditions

Gout; Gout Initiating Urate-loweringUrate-lowering Therapy

Keywords

Gout; urate-loweringUrate-lowering therapy

Outcome Measures

Primary Outcomes (1)

• Mean Number of Gout Flares Per Participant

  Baseline to Week 12

Secondary Outcomes (4)

• Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization

  Baseline to Week 12

• Time from Randomization to the First Flare

  Baseline to Week 12

• Mean duration of flares

  Baseline to Week 12

• 5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

  Baseline to Week 12

Other Outcomes (1)

• 6. Immunogenic Outcome The incidence of anti-drug antibodies and the incidence of neutralizing antibody

  Baseline to Week 12

Study Arms (2)

Genakumab group

EXPERIMENTAL

Genakumab 100mg single injection、Genakumab 200mg single injection

Drug: Genakumab for injection

Colchicine group

ACTIVE COMPARATOR

Oral colchicine 0.5mg once a day for 12 weeks

Drug: Colchicine

Interventions

Genakumab for injection DRUG

150 mg/1ml/ vial

Genakumab group

Colchicine DRUG

0.5 mg/table

Colchicine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Signed written informed consent before any study procedure is performed. 2. Male or female, 18 years ≤ age ≤ 75 years. 3. BMI ≤ 40kg/m2. 4. Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of arthritis of primary gout. 5. History of ≥2 gout flare within 12 months prior to screening. 6. Willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Huashan Hospital: collaborator

Study Sites (1)

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Gout

Interventions

Injections; Colchicine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Alkaloids; Heterocyclic Compounds

Study Officials

• Hejian Zou

  Fudan University Affiliated Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Gout patients initiating urate-lowering therapy Group A: Genakumab 100mg single injection; Group B: Genakumab 200mg single injection;Group C: Oral colchicine 0.5mg once a day for 12 weeks

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 7, 2023
• Study Start: July 20, 2023
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

CN (1)