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Completed

NCT Number: NCT05983445

Safety & Efffficacy of Genakumab in Patients With Frequent Flares

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

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Key information

Conditions

Acute Gout Arthritis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

About this study

A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

GenaKumab

Drug

200mg s.c.

Other names: • Gensci048

placebo for Diprospan

Drug

i.m.

placebo for genakumab

Drug

s.c.

Diprospan

Drug

7mg i.m.

Primary outcomes

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

    Time frame: 72 hours post-dose

    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.

  2. Time to first new flare

    Time frame: 12 weeks

Secondary outcomes

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

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

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

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

  3. The number of patients with at least 1 new gout flare

    Time frame: 12 weeks, 24 weeks, 48 weeks

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

    Time frame: 7 days

  5. Percent Patients Who Took Rescue Medication

    Time frame: 24 weeks,48 weeks

  6. Time to first flare

    Time frame: 24 weeks, 48 weeks

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

    Time frame: 24weeks, 48weeks

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

    Time frame: 24 weeks, 48 weeks

  9. Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period

    Time frame: 2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose

    Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose.

Other outcomes

  1. High Sensitivity C-reactive Protein (hsCRP)

    Time frame: 72 hours, 7 days and 4 weeks post-dose

  2. SF-36

    Time frame: 8 weeks, 24 weeks and 48 weeks

    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.

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Safety & Efficacy of Genakumab in Patients With Frequent Flares

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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