Safety & Efficacy of Genakumab in Patients With Frequent Flares

Acute Gout Clinical Trial

Official title:

Safety & Efficacy of Genakumab in Patients With Frequent Flares

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983445
• Other study ID #: 048-301
• Status: Recruiting
• Phase: Phase 3
• Start date: January 15, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2022
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Ting Liu
• Phone: 18946532759
• Email: liuting01[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout

Description:

Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group.

Phase II: randomized, double-blind, active control design.There are 2 dose groups of Genakumab for Injection with 30 participant s in each group and 1 group of Compound Betamethasone Injection with 30 praticipants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: July 31, 2024
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female, 18 years = age =75 years

• BMI=40kg/m2

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

• Start of acute gout flare within 4 days prior to enrolled

• History of = 2 gout flares within the 12 months prior to study start

• Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines

• Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Acute Gout

Intervention

Drug:
• genakumab
200mg s.c.
• placebo for Diprospan
i.m.
• placebo for genakumab
s.c.
• Diprospan
7mg i.m.

Locations

Country	Name	City	State
China	Fudan University Affiliated Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High Sensitivity C-reactive Protein (hsCRP)		72 hours, 7 days and 4 weeks post-dose
Other	SF-36	The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.	8 weeks, 24 weeks and 48 weeks
Primary	The change in the gout pain intensity in the target joint measured by VAS	The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.	72 hours post-dose
Primary	Time to first new flare		12 weeks
Secondary	Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)		At 6, 12, 24, 48, and 72 hours and 7 days post-dose
Secondary	The change in the gout pain intensity in the target joint measured by VAS.		At 6, 12, 24, 48, and 72 hours and 7 days post-dose
Secondary	The number of patients with at least 1 new gout flare		12 weeks, 24 weeks, 48 weeks
Secondary	Time to at Least a 50% Reduction in Baseline Pain Intensity		12 weeks
Secondary	Percent Patients Who Took Rescue Medication		12 weeks
Secondary	Time to first flare		24 weeks, 48 weeks
Secondary	Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)		12 weeks, 24weeks, 48weeks
Secondary	Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody		24 weeks, 48 weeks
Secondary	Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period	Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4,8,29,57,85,169,253 days post-dose.	2 hours pre-dose, Days 4,8,29,57,85,169,253 days post-dose