Safety & Efficacy of Genakumab in Patients With Frequent Flares
Study Details
Study Description
Brief Summary
To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Genakumab Genakumab 200mg s.c |
Drug: genakumab
200mg s.c.
Other Names:
Drug: placebo for Diprospan
i.m.
|
| Active Comparator: Diprospan Diprospan 7mg im |
Drug: placebo for genakumab
s.c.
Drug: Diprospan
7mg i.m.
|
Outcome Measures
Primary Outcome Measures
- The change in the gout pain intensity in the target joint measured by VAS [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.
- Time to first new flare [12 weeks]
Secondary Outcome Measures
- 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]
- 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]
- 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 [12 weeks]
- Percent Patients Who Took Rescue Medication [12 weeks]
- Time to first flare [24 weeks, 48 weeks]
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [12 weeks, 24weeks, 48weeks]
- Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody [24 weeks, 48 weeks]
- Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period [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 Outcome Measures
- High Sensitivity C-reactive Protein (hsCRP) [72 hours, 7 days and 4 weeks post-dose]
- SF-36 [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.
Eligibility Criteria
Criteria
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Affiliated Huashan Hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- GeneScience Pharmaceuticals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 048-301