Acute GoutPhase 1/2NCT05588908
A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
A Phase 1/2 study testing Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib), Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib) and Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib) in people with Acute Gout, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Gout
- What is being tested?
- Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib), Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib) and Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 29 Jun 2022to Nov 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
Site 03
Linyi, Shandong, 276100
Zhenchun Zhang, MD, +86 0539-8096886, zzclyh@126.com
Zhenchun Zhang
- Recruiting
Site 01
Shanghai, Shanghai Municipality, 200040
Hejian Zou, MD, +86 13311881366, hjzou@fudan.edu.cn
Hejian Zou
- Recruiting
Site 02
Wuhan, Hubei, 430030
Lingli Dong, MD, +86 027-83665518, tjhdongll@163.com
Lingli Dong
About this study
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
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.
Read the 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.
- Conditions
- Acute Gout
- Being tested
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)Drug
Also called SSGJ-613 100 mg (phase Ib)
100 mg subcutaneous (s.c) once
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)Drug
Also called SSGJ-613 200 mg (phase Ib)
200 mg subcutaneous (s.c) once
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)Drug
Also called SSGJ-613 300 mg (phase Ib)
300 mg subcutaneous (s.c) once
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)Drug
Also called SSGJ-613 200 mg (phase II)
one s.c. injection of SSGJ-613 once, on Day 1.
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)Drug
Also called SSGJ-613 300 mg (phase II)
one s.c. injection of SSGJ-613 once, on Day 1.
Compound Betamethasone Injection (phase II)Drug
1 mL i.m. once on Day 1
Placebo (phase II)Other
Also called PBO
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Compound Betamethasone Injection (phase II); Other: Placebo (phase II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the safety characteristics.
Measured: 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.
Measured: 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).
Measured: Baseline, at 72 hrs post-dose
Secondary outcomes (11)
Phase Ib: Pharmacokinetic (PK) Cmax
PK parameters (Cmax) following single dose.
Measured: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) Tmax
PK parameters (Tmax) following single dose.
Measured: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) AUC 0-t
PK parameters (AUC 0-t) following single dose.
Measured: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) AUC 0-∞
PK parameters (AUC 0-∞) following single dose.
Measured: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) t1/2
PK parameters (t1/2) following single dose.
Measured: From baseline through 24 weeks
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.
Measured: At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks post-dose
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.
Measured: At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks post-dose
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).
Measured: Baseline, at 6, 12, 24, 48 hrs post-dose
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).
Measured: Baseline, within 7 days after study drug administration
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.
Measured: Baseline, within 12 weeks after study drug administration
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.
Measured: 7 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start29 Jun 2022
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GoutStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hejian Zou, MD, Principal investigator, Shanghai Huanshan Hospital Fudan University-RheumatologyQinghong Zhou, MD, Study director, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588908
- Sponsor's protocol ID
- SSGJ-613-AG-Ib/II-01
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05588908
- Acronym / sponsor ID
- SSGJ-613-AG-Ib/II-01
- Conditions
- Acute Gout
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SSGJ-613 100 mg (phase Ib) | Experimental | Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)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. |
| SSGJ-613 200 mg (phase Ib) | Experimental | Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)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. |
| SSGJ-613 300 mg (phase Ib) | Experimental | Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)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. |
| SSGJ-613 200 mg (phase II) | Experimental | Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)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. |
| SSGJ-613 300 mg (phase II) | Experimental | Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)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. |
| Compound Betamethasone Injection 1 mL (phase II) | Active comparator | Drug: Compound Betamethasone Injection (phase II), Other: Placebo (phase II)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)Also: SSGJ-613 100 mg (phase Ib)100 mg subcutaneous (s.c) once | Drug | SSGJ-613 100 mg (phase Ib) |
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)Also: SSGJ-613 200 mg (phase Ib)200 mg subcutaneous (s.c) once | Drug | SSGJ-613 200 mg (phase Ib) |
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)Also: SSGJ-613 300 mg (phase Ib)300 mg subcutaneous (s.c) once | Drug | SSGJ-613 300 mg (phase Ib) |
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)Also: SSGJ-613 200 mg (phase II)one s.c. injection of SSGJ-613 once, on Day 1. | Drug | SSGJ-613 200 mg (phase II) |
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)Also: SSGJ-613 300 mg (phase II)one s.c. injection of SSGJ-613 once, on Day 1. | Drug | SSGJ-613 300 mg (phase II) |
| Compound Betamethasone Injection (phase II)1 mL i.m. once on Day 1 | Drug | Compound Betamethasone Injection 1 mL (phase II) |
| Placebo (phase II)Also: PBOParticipants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products. | Other | Compound Betamethasone Injection 1 mL (phase II) |
Primary outcome
Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From baseline through 24 weeks
To investigate the safety characteristics.
Phase Ib: Incidence and Severity of Abnormalities in Vital Signs/Physical Examinations, Laboratory Examinations and Other Relevant Examinations
Time frame: From baseline through 24 weeks
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)
Time frame: Baseline, at 72 hrs post-dose
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).
11 secondary outcomes
Phase Ib: Pharmacokinetic (PK) Cmax
Time frame: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) Tmax
Time frame: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) AUC 0-t
Time frame: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) AUC 0-∞
Time frame: From baseline through 24 weeks
Phase Ib: Pharmacokinetic (PK) t1/2
Time frame: From baseline through 24 weeks
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)
Time frame: At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks post-dose
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)
Time frame: At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks post-dose
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)
Time frame: Baseline, at 6, 12, 24, 48 hrs post-dose
The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint Within 7 Days after study drug administration
Time frame: Baseline, within 7 days after study drug administration
The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint Within 12 Weeks after study drug administration
Time frame: Baseline, within 12 weeks after study drug administration
Percentage of Participants Taking Rescue Medication Within 7 Days After Study Drug Administration
Time frame: 7 days after study drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hejian Zou, MD principal investigator
Shanghai Huanshan Hospital Fudan University-Rheumatology
Qinghong Zhou, MD study director
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib), Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib) and Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib) in people with Acute Gout, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Zhou, MD (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From baseline through 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.