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

Primary Purpose

Acute Gout

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)
Compound Betamethasone Injection (phase II)
Placebo (phase II)
Sponsored by
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gout

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 02Recruiting
  • Site 03
  • Site 01Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

SSGJ-613 100 mg (phase Ib)

SSGJ-613 200 mg (phase Ib)

SSGJ-613 300 mg (phase Ib)

SSGJ-613 200 mg (phase II)

SSGJ-613 300 mg (phase II)

Compound Betamethasone Injection 1 mL (phase II)

Arm Description

Dose Arm 1 (phase Ib): SSGJ-613 100 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.

Dose Arm 2 (phase Ib): SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.

Dose Arm 3 (phase Ib): SSGJ-613 300 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.

Dose Arm 4 (phase II): SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.

Dose Arm 5 (phase II): SSGJ-613 300 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.

Dose Arm 6 (phase II): Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1.

Outcomes

Primary Outcome Measures

Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the safety characteristics.
Phase Ib: Incidence and Severity of Abnormalities in Vital Signs/Physical Examinations, Laboratory Examinations and Other Relevant Examinations
To investigate the safety characteristics.
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).

Secondary Outcome Measures

Phase Ib: Pharmacokinetic (PK) Cmax
PK parameters (Cmax) following single dose.
Phase Ib: Pharmacokinetic (PK) Tmax
PK parameters (Tmax) following single dose.
Phase Ib: Pharmacokinetic (PK) AUC 0-t
PK parameters (AUC 0-t) following single dose.
Phase Ib: Pharmacokinetic (PK) AUC 0-∞
PK parameters (AUC 0-∞) following single dose.
Phase Ib: Pharmacokinetic (PK) t1/2
PK parameters (t1/2) following single dose.
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.
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.
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).
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).
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.
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.

Full Information

First Posted
October 17, 2022
Last Updated
October 17, 2022
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05588908
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SSGJ-613 100 mg (phase Ib)
Arm Type
Experimental
Arm Description
Dose Arm 1 (phase Ib): SSGJ-613 100 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Arm Title
SSGJ-613 200 mg (phase Ib)
Arm Type
Experimental
Arm Description
Dose Arm 2 (phase Ib): SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Arm Title
SSGJ-613 300 mg (phase Ib)
Arm Type
Experimental
Arm Description
Dose Arm 3 (phase Ib): SSGJ-613 300 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Arm Title
SSGJ-613 200 mg (phase II)
Arm Type
Experimental
Arm Description
Dose Arm 4 (phase II): SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.
Arm Title
SSGJ-613 300 mg (phase II)
Arm Type
Experimental
Arm Description
Dose Arm 5 (phase II): SSGJ-613 300 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.
Arm Title
Compound Betamethasone Injection 1 mL (phase II)
Arm Type
Active Comparator
Arm Description
Dose Arm 6 (phase II): Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1.
Intervention Type
Drug
Intervention Name(s)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)
Other Intervention Name(s)
SSGJ-613 100 mg (phase Ib)
Intervention Description
100 mg subcutaneous (s.c) once
Intervention Type
Drug
Intervention Name(s)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)
Other Intervention Name(s)
SSGJ-613 200 mg (phase Ib)
Intervention Description
200 mg subcutaneous (s.c) once
Intervention Type
Drug
Intervention Name(s)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)
Other Intervention Name(s)
SSGJ-613 300 mg (phase Ib)
Intervention Description
300 mg subcutaneous (s.c) once
Intervention Type
Drug
Intervention Name(s)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)
Other Intervention Name(s)
SSGJ-613 200 mg (phase II)
Intervention Description
one s.c. injection of SSGJ-613 once, on Day 1.
Intervention Type
Drug
Intervention Name(s)
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)
Other Intervention Name(s)
SSGJ-613 300 mg (phase II)
Intervention Description
one s.c. injection of SSGJ-613 once, on Day 1.
Intervention Type
Drug
Intervention Name(s)
Compound Betamethasone Injection (phase II)
Intervention Description
1 mL i.m. once on Day 1
Intervention Type
Other
Intervention Name(s)
Placebo (phase II)
Other Intervention Name(s)
PBO
Intervention Description
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Primary Outcome Measure Information:
Title
Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
To investigate the safety characteristics.
Time Frame
From baseline through 24 weeks
Title
Phase Ib: Incidence and Severity of Abnormalities in Vital Signs/Physical Examinations, Laboratory Examinations and Other Relevant Examinations
Description
To investigate the safety characteristics.
Time Frame
From baseline through 24 weeks
Title
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)
Description
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).
Time Frame
Baseline, at 72 hrs post-dose
Secondary Outcome Measure Information:
Title
Phase Ib: Pharmacokinetic (PK) Cmax
Description
PK parameters (Cmax) following single dose.
Time Frame
From baseline through 24 weeks
Title
Phase Ib: Pharmacokinetic (PK) Tmax
Description
PK parameters (Tmax) following single dose.
Time Frame
From baseline through 24 weeks
Title
Phase Ib: Pharmacokinetic (PK) AUC 0-t
Description
PK parameters (AUC 0-t) following single dose.
Time Frame
From baseline through 24 weeks
Title
Phase Ib: Pharmacokinetic (PK) AUC 0-∞
Description
PK parameters (AUC 0-∞) following single dose.
Time Frame
From baseline through 24 weeks
Title
Phase Ib: Pharmacokinetic (PK) t1/2
Description
PK parameters (t1/2) following single dose.
Time Frame
From baseline through 24 weeks
Title
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)
Description
The pain intensity post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain.
Time Frame
At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks post-dose
Title
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)
Description
The pain intensity post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain.
Time Frame
At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks post-dose
Title
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)
Description
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).
Time Frame
Baseline, at 6, 12, 24, 48 hrs post-dose
Title
The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint Within 7 Days after study drug administration
Description
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).
Time Frame
Baseline, within 7 days after study drug administration
Title
The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint Within 12 Weeks after study drug administration
Description
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.
Time Frame
Baseline, within 12 weeks after study drug administration
Title
Percentage of Participants Taking Rescue Medication Within 7 Days After Study Drug Administration
Description
Participants who had difficulty in tolerating their pain after the 12 and 72 hours post-dose pain assessments were allowed to take rescue medication.
Time Frame
7 days after study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinghong Zhou, MD
Phone
+86 18911301578
Email
zhouqinghong@3sbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hejian Zou, MD
Organizational Affiliation
Shanghai Huanshan Hospital Fudan University-Rheumatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qinghong Zhou, MD
Organizational Affiliation
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Site 02
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingli Dong, MD
Phone
+86 027-83665518
Email
tjhdongll@163.com
First Name & Middle Initial & Last Name & Degree
Lingli Dong
Facility Name
Site 03
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenchun Zhang, MD
Phone
+86 0539-8096886
Email
zzclyh@126.com
First Name & Middle Initial & Last Name & Degree
Zhenchun Zhang
Facility Name
Site 01
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hejian Zou, MD
Phone
+86 13311881366
Email
hjzou@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Hejian Zou

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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