Gensci 048-203: Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare

• Sponsor: GeneScience Pharmaceuticals Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05936268
• Collaborator: Huashan Hospital (Other)
• Enrollment: 106
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.8
• Patients Per Site Per Month: 13.7

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

Condition or Disease	Intervention/Treatment	Phase
Acute Gout; Gout Flare	Drug: Genakumab for injection; Drug: Colchicine	Phase 2

Detailed Description

Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare
• Anticipated Study Start Date: Jun 30, 2023
• Anticipated Primary Completion Date: Dec 21, 2023
• Anticipated Study Completion Date: Feb 21, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Genacumab group Genakumab 200mg single injection	Drug: Genakumab for injection; 150 mg/1ml/bottle
Active Comparator: cholchicine group Colchicine 0.5mg qd po.for 12 weeks	Drug: Colchicine; 0.5mg/table

Outcome Measures

Primary Outcome Measures

1. 72hours target joint VAS change from baseline [72h±2h]

   72hours target joint VAS change from baseline

Secondary Outcome Measures

1. Pain intensity [6hours, 24hours, 48hours, 72hours, Day 8,]

   target joint VAS Target joint VAS change from baseline Time to first VAS<=50% baseline VAS Time to first VAS<=30mm Time to first VAS<=10mm

2. Recurrence of flare [12 weeks after the last dose]

   Proportion of patients who have at least 1 flare Time to first flare

3. Safety outcome [12weeks]

   AE, laboratory examination, ECG, vital signs and physical examination

4. immunogenic outcome [12 weeks after the last dose]

   The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Male or female, 18 years ≤ age ≤ 75 years;

2. BMI ≤ 40kg/m2

3. Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;

4. Start of acute gout flare within 3 days prior to enrolled;

5. History of ≥2 gout flare within 12 months prior to study start;

6. Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Affiliated Huashan Hospital	Shanghai	Shanghai	China	200030

Sponsors and Collaborators

• GeneScience Pharmaceuticals Co., Ltd.
• Huashan Hospital

Investigators

• Principal Investigator: Hejian Zou, Fudan University Affiliated Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05936268
• Other Study ID Numbers: GenSci048-203
• First Posted: Jul 7, 2023
• Last Update Posted: Jul 11, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GeneScience Pharmaceuticals Co., Ltd.: Acute gout; Gout flare
• Additional relevant MeSH terms: Gout; Arthritis, Gouty; Colchicine

Study Results

No Results Posted as of Jul 11, 2023