Safety & Efffficacy of Genakumab in Patients With Frequent Flares

NCT05983445 | Completed Phase 3 FDA Drug

• 1 other identifier: GenSci048-301
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).

Conditions

Acute Gout Arthritis

Keywords

Acute Gout Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

• Time to first new flare

  12 weeks

Secondary Outcomes (9)

• Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)

  At 6, 24, 48, and 72 hours and 7 days post-dose

• The change in the gout pain intensity in the target joint measured by VAS.

  At 6, 24, 48, and 72 hours and 7 days post-dose

• The number of patients with at least 1 new gout flare

  12 weeks, 24 weeks, 48 weeks

• Time to at Least a 50% Reduction in Baseline Pain Intensity

  7 days

• Percent Patients Who Took Rescue Medication

  24 weeks,48 weeks

Other Outcomes (2)

• High Sensitivity C-reactive Protein (hsCRP)

  72 hours, 7 days and 4 weeks post-dose

• SF-36

  8 weeks, 24 weeks and 48 weeks

Study Arms (2)

Genakumab

EXPERIMENTAL

Genakumab 200mg s.c

Drug: genakumab; Drug: placebo for Diprospan

Diprospan

ACTIVE COMPARATOR

Diprospan 7mg im

Drug: placebo for genakumab; Drug: Diprospan

Interventions

genakumab DRUG

200mg s.c.

Also known as: • Gensci048

Genakumab

placebo for Diprospan DRUG

i.m.

Genakumab

placebo for genakumab DRUG

s.c.

Diprospan

Diprospan DRUG

7mg i.m.

Diprospan

Eligibility Criteria

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

You may qualify if:

• 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)

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

betamethasone dipropionate, betamethasone sodium phosphate drug combination

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: August 9, 2023
• Study Start: January 11, 2023
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-11

Locations

CN (1)