A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

Acute Gout Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588908
• Other study ID #: SSGJ-613-AG-Ib/II-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 29, 2022
• Est. completion date: November 2023

Study information

• Verified date: October 2022
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: Qinghong Zhou, MD
• Phone: +86 18911301578
• Email: zhouqinghong[@]3sbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gout
• Arthritis, Gouty
• Gout

Intervention

Drug:
• Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection 100 mg (phase Ib)
100 mg subcutaneous (s.c) once
• Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection 200 mg (phase Ib)
200 mg subcutaneous (s.c) once
• Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection 300 mg (phase Ib)
300 mg subcutaneous (s.c) once
• Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection 200 mg (phase II)
one s.c. injection of SSGJ-613 once, on Day 1.
• Recombinant Anti-IL-1ß Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)
one s.c. injection of SSGJ-613 once, on Day 1.
• Compound Betamethasone Injection (phase II)
1 mL i.m. once on Day 1

Other:
• Placebo (phase II)
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.

Locations

Country	Name	City	State
China	Site 03	Linyi	Shandong
China	Site 01	Shanghai	Shanghai
China	Site 02	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	To investigate the safety characteristics.	From baseline through 24 weeks
Primary	Phase Ib: Incidence and Severity of Abnormalities in Vital Signs/Physical Examinations, Laboratory Examinations and Other Relevant Examinations	To investigate the safety characteristics.	From baseline through 24 weeks
Primary	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)	The change in pain intensity from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).	Baseline, at 72 hrs post-dose
Secondary	Phase Ib: Pharmacokinetic (PK) Cmax	PK parameters (Cmax) following single dose.	From baseline through 24 weeks
Secondary	Phase Ib: Pharmacokinetic (PK) Tmax	PK parameters (Tmax) following single dose.	From baseline through 24 weeks
Secondary	Phase Ib: Pharmacokinetic (PK) AUC 0-t	PK parameters (AUC 0-t) following single dose.	From baseline through 24 weeks
Secondary	Phase Ib: Pharmacokinetic (PK) AUC 0-8	PK parameters (AUC 0-8) following single dose.	From baseline through 24 weeks
Secondary	Phase Ib: Pharmacokinetic (PK) t1/2	PK parameters (t1/2) following single dose.	From baseline through 24 weeks
Secondary	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)	The pain intensity post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain.	At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks post-dose
Secondary	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)	The pain intensity post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain.	At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks post-dose
Secondary	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)	The change in pain intensity from baseline to 6, 12, 24, 48 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).	Baseline, at 6, 12, 24, 48 hrs post-dose
Secondary	The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint Within 7 Days after study drug administration	The time to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).	Baseline, within 7 days after study drug administration
Secondary	The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint Within 12 Weeks after study drug administration	The time to complete pain remission in Pain intensity from baseline as measured by a 5-point Likert scale for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.	Baseline, within 12 weeks after study drug administration
Secondary	Percentage of Participants Taking Rescue Medication Within 7 Days After Study Drug Administration	Participants who had difficulty in tolerating their pain after the 12 and 72 hours post-dose pain assessments were allowed to take rescue medication.	7 days after study drug administration