Plaque Psoriasis with Arthritic Symptoms
Conditions
Interventions
Dose Group 1 – Investigational Drug Group:KYS202004A Injection, 3.0 mg/kg, intravenous infusion, once every 2 weeks, for a total of 6 doses
Dose Group 1 – Placebo Group:KYS202004A Injection Placebo, intravenous infusion, once every 2 weeks, for a total of 6 doses
Dose Group 2 – Investigational Drug Group:KYS202004A Injection, 6.0 mg/kg, intravenous infusion, once every 2 weeks, for a total of 6 doses
Dose Group 2 – Placebo Group:KYS202004A Injection Placebo, intravenous infusion, once every 2 weeks, for a total of 6 doses
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and comply with the trial procedures, voluntarily participate in the trial, and sign the informed consent form. 2. Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of sex. 3. At screening, have at least one plaque psoriasis lesion with a diameter of =2 cm, or any characteristic nail or nail bed changes of psoriasis (PsO), or a previously documented history of plaque psoriasis; and have a diagnosis of psoriatic arthritis at least 3 months prior to the first dose of study drug, and meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening; and have active arthritis at both screening and baseline, defined as the presence of =3 tender joints and =3 swollen joints. 4. Have an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) such as methotrexate, and have been on stable treatment with methotrexate tablets (MTX) (i.e., a stable oral dose of 7.5–20 mg/week) for at least 4 weeks prior to enrollment. If any csDMARDs other than MTX (e.g., iguratimod, hydroxychloroquine, sulfasalazine) have been used prior to enrollment, a washout period of at least 28 days is required. If leflunomide has been used prior to enrollment, a washout period of at least 12 weeks is required. If oral corticosteroids (=10 mg/day prednisone equivalent) have been used prior to enrollment, a washout period of at least 28 days is required. 5. Male participants and non-sterilized, premenopausal female participants must agree to use a medically accepted contraceptive method from the time of study participation until at least 6 months after the last dose, or use appropriate and effective contraception in accordance with regulations or guidelines. Medically accepted contraceptive methods include, but are not limited to: condoms (male or female), with or without spermicide; diaphragm or cervical cap with spermicide; prescription intrauterine device (IUD) (inert or copper-containing); hormone-releasing IUD; systemic hormonal contraceptives; and surgical sterilization (e.g., hysterectomy or tubal ligation). 6. For women of childbearing potential, a negative pregnancy test result at screening/baseline.
Exclusion criteria
Exclusion criteria: 1. Patients with autoimmune or inflammatory diseases other than psoriatic arthritis, including but not limited to rheumatoid arthritis, axial spondyloarthritis (except primary diagnosis of psoriatic arthritis with spondylitis), systemic lupus erythematosus, or patients with a gout flare within 4 weeks before enrollment, joint tophi, or refractory hyperuricemia. 2. Participants who plan to require additional topical therapy, phototherapy, or other systemic treatment for psoriasis other than the study drug during the trial. 3. Any infection requiring systemic antibiotic therapy within 2 weeks before screening, or a history of recurrent infections; or a serious infection requiring hospitalization or intravenous antibiotic therapy within 8 weeks before screening (e.g., pneumonia, cellulitis, bone or joint infection). 4. Known allergy to KYS202004A injection or related excipients. 5. At screening, positive for human immunodeficiency virus (HIV) antibody (HIVAb), and/or positive for Treponema pallidum specific antibody; and/or positive for hepatitis C virus antibody (HCVAb) and positive by HCV-RNA reverse transcription polymerase chain reaction test, indicating previous or current infection; and/or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and positive by HBV-DNA polymerase chain reaction test, indicating current infection. 6. Clinical evidence of active tuberculosis or suspicion of active tuberculosis, or evidence of prior active tuberculosis without appropriate treatment or with missing treatment records; or evidence of latent tuberculosis infection at screening. 7. At screening, alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase >1.5 × upper limit of normal (ULN); serum creatinine >1.5 × ULN, or creatinine clearance <60 mL/min; hemoglobin <10.0 g/dL (100.0 g/L) for males, or <9.0 g/dL (90.0 g/L) for females; absolute neutrophil count <1.5 × 10?/L; platelet count <100 × 10?/L; and any other laboratory abnormality that, in the investigator’s opinion, would preclude the participant from completing the study or interfere with the interpretation of study results. 8. History of or concurrent malignant neoplasm (except successfully treated basal cell carcinoma, cutaneous squamous cell carcinoma in situ, squamous cell carcinoma without evidence of recurrence within 5 years, or adequately treated carcinoma in situ of the cervix). 9. Receipt of a live attenuated vaccine within 4 weeks before the first dose of study drug, or intent to receive a live attenuated vaccine during the trial. 10. Currently participating in another interventional clinical trial, or receipt of a clinical trial intervention within 4 weeks before the first dose of study drug, or, before the first dose of study drug, the last dose of a previous clinical trial has not been washed out for at least 7 half-lives, whichever is longer. Note: This excludes participants in observational studies or non-interventional clinical studies. 11. Participant is a member of the site staff or the sponsor’s/designee’s personnel directly involved in this trial. 12. Participants who have previously used both IL-17 and TNF-a biologics and had an inadequate response to both. 13. Any significant organ dysfunction or clinically significant laboratory abnormality within 6 months before screening that, in the investigator’s judgment, places the participant at an unacceptable risk by participating in an immunomo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, type, and severity of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;Clinical laboratory tests (complete blood count, blood biochemistry, urinalysis, and coagulation function);Vital signs (blood pressure, pulse, respiration, and body temperature);12-lead electrocardiogram (ECG);Achievement of =20% improvement in disease activity according to the American College of Rheumatology improvement criteria (ACR20) at Week 12;ACR20 response rates at Weeks 1, 2, 4, and 8;>=50% improvement (ACR50) and >=70% improvement (ACR70) response rates at Weeks 1, 2, 4, 8, and 12;Mean change from baseline in the 28-joint Disease Activity Score based on high-sensitivity C-reactive protein (DAS28-hsCRP) at Weeks 1, 2, 4, 8, and 12;Achievement of >=50% (PASI50), >=75% (PASI75), and >=90% (PASI90) improvement in the Psoriasis Area and Severity Index skin score at Weeks 1, 2, 4, 8, and 12;Physician’s Global Assessment (PGA) score of 0 or 1 (on a 0–5 scale) at Week 12;Change from baseline in the Dermatology Life Quality Index (DLQI) at Weeks 1, 2, 4, 8, and 12;Change from baseline in the Pruritus Numeric Rating Scale (NRS) at Weeks 1, 2, 4, 8, and 12;Pharmacokinetic (PK) parameters (including but not limited toCmax, Tmax, AUC0-t, AUC0-8, t1/2, CL, V, and MRT);Incidence of anti-drug antibodies (ADA) and neutralizing antibody levels;Biomarkers: Serum levels of TNF-a and IL-17A, and changes from baseline.; | — |
Countries
China
Contacts
Public ContactDai Shengming
Shanghai Sixth People’s Hospital
Outcome results
None listed