Clinical trial NCT05588908: A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Official title: A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Gout
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the target dose of phase II and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-IL-1β humanized monoclonal antibody injection at different doses in Chinese participants with acute gout.

Detailed description: The phase Ib study is a multi-center, open label, dose escalation study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection and to determine the target dose of phase II for the treatment of acute flare in Chinese gout patients in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. There are 3 dose groups (100 mg、200 mg and 300 mg) in phase Ib and 10 participants in each group.

The phase II study is a dose-ranging, multi-center, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of 2 dose regimens (200 mg and 300 mg, based on the outcome of phase Ib) of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection for the treatment of acute flare in Chinese gout patients in whom NSAIDs and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. The phase II recommended dose of SSGJ-613 in subjects with acute gouty was determined according to the phase Ib interim analysis results.

Eligibility criteria: Inclusion Criteria:

* Must be 18 Years to 65 Years, both male and female
* Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
* Presence of acute gout flare for no longer than 7 days
* Baseline pain intensity \> or = to 50 mm on the 0-100 mm VAS
* Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both

Exclusion Criteria:

* Secondary gout (such as gout caused by chemotherapy, transplant gout, etc.)
* Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
* Presence of severe renal function impairment
* Intolerance of subcutaneous and intramuscular injection
* Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
* History of malignant tumor within 5 years before screening
* Live vaccinations within 3 months prior to the start of the study
* Use of forbidden therapy

Primary outcomes:
measure: Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From baseline through 24 weeks
measure: Phase Ib: Incidence and Severity of Abnormalities in Vital Signs/Physical Examinations, Laboratory Examinations and Other Relevant Examinations
timeFrame: From baseline through 24 weeks
measure: Phase II: The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
timeFrame: Baseline, at 72 hrs post-dose
Secondary outcomes:
measure: Phase Ib: Pharmacokinetic (PK) Cmax
timeFrame: From baseline through 24 weeks
measure: Phase Ib: Pharmacokinetic (PK) Tmax
timeFrame: From baseline through 24 weeks
measure: Phase Ib: Pharmacokinetic (PK) AUC 0-t
timeFrame: From baseline through 24 weeks
measure: Phase Ib: Pharmacokinetic (PK) AUC 0-∞
timeFrame: From baseline through 24 weeks
measure: Phase Ib: Pharmacokinetic (PK) t1/2
timeFrame: From baseline through 24 weeks
measure: Phase Ib: The Pain Intensity in the Target Joint at 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
timeFrame: At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks post-dose
measure: Phase II: The Pain Intensity in the Target Joint at 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
timeFrame: At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks post-dose
measure: The Change in Pain Intensity in the Target Joint From Baseline to 6, 12, 24, 48 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
timeFrame: Baseline, at 6, 12, 24, 48 hrs post-dose
measure: The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint Within 7 Days after study drug administration
timeFrame: Baseline, within 7 days after study drug administration
measure: The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint Within 12 Weeks after study drug administration
timeFrame: Baseline, within 12 weeks after study drug administration
measure: Percentage of Participants Taking Rescue Medication Within 7 Days After Study Drug Administration
timeFrame: 7 days after study drug administration
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Site 02
state: Hubei
city: Linyi
country: China
facility: Site 03
state: Shandong
city: Shanghai
country: China
facility: Site 01
state: Shanghai
Study officials:
affiliation: Shanghai Huanshan Hospital Fudan University-Rheumatology
name: Hejian Zou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
name: Qinghong Zhou, MD
role: STUDY_DIRECTOR
References: