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

NCT05588908 | Unknown Phase 1

• 1 other identifier: SSGJ-613-AG-Ib/II-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Gout

Outcome Measures

Primary Outcomes (3)

• Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  To investigate the safety characteristics.

  From baseline through 24 weeks

• 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

• 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 Outcomes (11)

• Phase Ib: Pharmacokinetic (PK) Cmax

  From baseline through 24 weeks

• Phase Ib: Pharmacokinetic (PK) Tmax

  From baseline through 24 weeks

• Phase Ib: Pharmacokinetic (PK) AUC 0-t

  From baseline through 24 weeks

• Phase Ib: Pharmacokinetic (PK) AUC 0-∞

  From baseline through 24 weeks

• Phase Ib: Pharmacokinetic (PK) t1/2

  From baseline through 24 weeks

Study Arms (6)

SSGJ-613 100 mg (phase Ib)

EXPERIMENTAL

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.

Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)

SSGJ-613 200 mg (phase Ib)

EXPERIMENTAL

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.

Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)

SSGJ-613 300 mg (phase Ib)

EXPERIMENTAL

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.

Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)

SSGJ-613 200 mg (phase II)

EXPERIMENTAL

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.

Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)

SSGJ-613 300 mg (phase II)

EXPERIMENTAL

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.

Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)

Compound Betamethasone Injection 1 mL (phase II)

ACTIVE COMPARATOR

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.

Drug: Compound Betamethasone Injection (phase II); Other: Placebo (phase II)

Interventions

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib) DRUG

100 mg subcutaneous (s.c) once

Also known as: SSGJ-613 100 mg (phase Ib)

SSGJ-613 100 mg (phase Ib)

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib) DRUG

200 mg subcutaneous (s.c) once

Also known as: SSGJ-613 200 mg (phase Ib)

SSGJ-613 200 mg (phase Ib)

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib) DRUG

300 mg subcutaneous (s.c) once

Also known as: SSGJ-613 300 mg (phase Ib)

SSGJ-613 300 mg (phase Ib)

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II) DRUG

one s.c. injection of SSGJ-613 once, on Day 1.

Also known as: SSGJ-613 200 mg (phase II)

SSGJ-613 200 mg (phase II)

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II) DRUG

one s.c. injection of SSGJ-613 once, on Day 1.

Also known as: SSGJ-613 300 mg (phase II)

SSGJ-613 300 mg (phase II)

Compound Betamethasone Injection (phase II) DRUG

1 mL i.m. once on Day 1

Compound Betamethasone Injection 1 mL (phase II)

Placebo (phase II) OTHER

Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.

Also known as: PBO

Compound Betamethasone Injection 1 mL (phase II)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (3)

Site 02

Wuhan, Hubei, 430030, China

RECRUITING

Site 03

Linyi, Shandong, 276100, China

NOT YET RECRUITING

Site 01

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Interventions

Clinical Trials, Phase II as Topic

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hejian Zou, MD

  Shanghai Huanshan Hospital Fudan University-Rheumatology

  PRINCIPAL INVESTIGATOR

• Qinghong Zhou, MD

  Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Qinghong Zhou, MD

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: June 29, 2022
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)