Psoriatic arthritis
Conditions
Interventions
Phase II-IBI112-Group 1:receive IBI112 from week 0 and maintain the medication every 6 weeks until week 44.
Phase II-IBI112-Group 2:receive IBI112 from week 0 and maintain the medication every 12 weeks until week 44.
Phase II-placebo group:receive IBI112 from week 26 and maintain the medication every 12 weeks until week 44.
Phase III-IBI112-Group 2:receive IBI112 from week 0 and maintain the medication every 12 weeks until week 44.
Phase III-placebo group:receive IBI112 from week 26 and maintain the medication every 12 weeks until week 44.
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Males or females aged between 18 and 75 years old (inclusive); 2. Diagnosed with psoriatic arthritis for at least 6 months prior to first dose of the study drug, and meeting the classification criteria for psoriatic arthritis (CASPAR) at screening; 3. Meeting the definition of active PsA at screening and baseline: At least 3 swollen joints (66 joints) and at least 3 tender joints (68 joints), with C-reactive protein level >=3 mg/L at screening; 4. Active plaque psoriasis, with at least one psoriatic plaque >=2 cm in diameter and/or psoriatic nail involvement; or documented history of plaque psoriasis; 5. Active PsA despite prior treatment with non-biologic DMARDs and/or NSAIDs: - Non-biologic DMARD treatment requirements: Usage of one non-biologic DMARD for at least 3 months or evidence of intolerance; - NSAID treatment requirements: Usage of one NSAID for at least 4 weeks or evidence of intolerance. 6. Participants may have previously received TNF-a antagonist therapy: -Following at least 12 weeks of treatment with etanercept, adalimumab, golimumab, or certolizumab, and/or at least 14 weeks of infliximab, the treating physician determined that the participant demonstrated lack of benefit from TNF-a antagonist therapy. Lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; - Treatment with TNF-a antagonists was deemed intolerable by the treating physician following use of etanercept, adalimumab, golimumab, certolizumab, or infliximab. 7. Participants may have previously received treatment with IL-12/23p40, IL-17, and/or IL-23p19 antagonists: - Following at least 16 weeks of treatment with IL-12/23p40, IL-17, and/or IL-23p19 antagonists, the treating physician determined that these biologics provided no benefit. Lack of benefit may include insufficient improvement in joint counts, physical function, or disease activity; - Following treatment with IL-12/23p40, IL-17, and/or IL-23p19 antagonists, the treating physician determined that the participant was intolerant to these biologics. 8. Participants may have previously received JAK inhibitor therapy: - Following JAK inhibitor use, the treating physician determined a lack of benefit. Lack of benefit may include insufficient improvement in joint counts, physical function, or disease activity; - Following JAK inhibitor therapy, the treating physician determined intolerance. 9. If currently using DMARDs (limited to methotrexate, sulfasalazine, hydroxychloroquine, and leflunomide), these should have been initiated at least 3 months prior to the first dose of study drug, maintained at a stable dose for at least 4 weeks, and without severe adverse effects attributable to the DMARDs. If methotrexate, sulfasalazine, or hydroxychloroquine has been discontinued, it must have been discontinued for at least 4 weeks prior to the first dose of study drug. If leflunomide has been discontinued, it must have been discontinued for at least 12 weeks prior to the first dose of study drug. If receiving the above medications, their use and stable doses must meet the following: - Methotrexate <= 25 mg/week; - Sulfasalazine <= 3 g/day; - Hydroxychloroquine <= 400 mg/day; - Leflunomide <= 20 mg/day. 10. If currently using NSAIDs or other analgesics for PsA treatment, the patient should have been on a stable dose for at least 2 weeks prior to the first administration of the study drug. If not currently using such medications, they should have been discontinu
Exclusion criteria
Exclusion criteria: 1. Other inflammatory diseases that may affect the evaluation of the study drug, including but not limited to rheumatoid arthritis, axial spondyloarthritis (excluding PsA with spondylitis diagnosis), systemic lupus erythematosus, or Lyme disease; 2. Previously received treatment with more than two biologic agents; 3. Received treatment with a TNF-a antagonist within the following time periods prior to the first dose of the study drug: Infliximab or golimumab administered intravenously: 8 weeks; Golimumab administered subcutaneously, adalimumab, or certolizumab: 6 weeks; Etanercept: 4 weeks; 4. Previously received treatment with Picankibart; 5. Treatment with IL-12/23p40, IL-17, and/or IL-23p19 antagonists within 12 weeks prior to the first dose of the study drug; 6. Previous administration of JAK inhibitors such as tofacitinib or baricitinib within 4 weeks prior to the first dose of the study drug; 7. Received systemic immunosuppressive therapy within 4 weeks prior to the first dose of the study drug (including azathioprine, cyclosporine, 6-mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus); 8. Received other non-biologic DMARDs within 4 weeks prior to the first dose of the study drug, including but not limited to chloroquine, gold compounds, and penicillamine; 9. Currently receiving two or more DMARDs; 10. Received phototherapy or other systemic treatments affecting psoriasis assessment (including but not limited to retinoids, apremilast) within 4 weeks prior to first dose of the study drug, and/or unwillingness to avoid persistent sun exposure or other ultraviolet light sources during the study period; 11. Received topical therapy affecting psoriasis assessment within 2 weeks prior to first dose of the study drug (including but not limited to corticosteroids, topical vitamin D3 derivatives, retinoids, calcineurin inhibitors, and pimecrolimus); 12. Received corticosteroids (including adrenocorticotropic hormone) via epidural, intra-articular, intramuscular, or intravenous administration within 4 weeks prior to the first dose of the study drug; 13. Received lithium preparations within 4 weeks prior to the first dose of the study drug; 14. Received administration of an investigational antibody or biologic agent, or other investigational drug within 3 months prior to the first dose of the study drug, or within 5 half-lives of the drug (whichever is longer), or is currently using other investigational drugs or participating in other trials; 15. Having non-plaque psoriasis (such as pustular, erythrodermic, or guttate psoriasis); 16. Having drug-induced psoriasis (such as new-onset psoriasis or worsening psoriasis caused by beta-blockers, calcium channel blockers, or lithium); 17. Severe, progressive, or uncontrolled kidney, liver, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions; 18. Unstable cardiovascular disease, defined as recent clinical worsening within 3 months prior to screening (e.g., unstable angina, rapid atrial fibrillation, or transient ischemic attack) or hospitalization for heart disease within 3 months prior to screening; 19. Currently suffering from malignant tumors or having a history of malignant tumors within 5 years prior to screening (excluding squamous cell carcinoma of the skin, basal cell carcinoma, or localized cervical carcinoma in situ that have been adequately treated and show no evide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants achieving the American College of Rheumatology 20 Response (ACR20) at Week 26; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in DAS28-CRP Score from Baseline at Week 26;The proportion of participants achieving the American College of Rheumatology 50 Response (ACR50) at Week 26;Change in SF-36-PCS relative to baseline at Week 26;Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 26 relative to baseline; | — |
Countries
China
Contacts
Public ContactXiaoyong Man
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed