EUCTR2022-000847-62-PL进行中（未招募）1 期
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients with Moderate-to-Severe Active Psoriatic Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or non-pregnant, non-breastfeeding female patients aged 18 to 75 years, inclusive, at the time of signing the informed consent form (ICF).
- •2. Able to comprehend and be willing to sign the institutional review board (IRB) approved patient ICF before administration of any study-related procedures.
- •3. Diagnosis of PsA with symptom onset at least 6 months before the Screening Visit and fulfilment of the Classification Criteria for PsA at the time of Screening.
- •4. Patient has moderate-to-severe PsA at Screening and Randomization Visits defined as:
- •o =3 tender joints (based on 68 joint counts) and
- •o =3 swollen joints (based on 66 joint counts).
- •5. Creatine kinase (CK) is = 3 times upper limit of normal (ULN) at screening.
- •6. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
- •7. Patient had an inadequate response (lack of efficacy after a minimum 12-week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (MTX, sulfasalazine, leflunomide, cyclosporine, hydroxychloroquine, apremilast, bucillamine, or iguratimod), or patient has an intolerance, or contraindication for DMARDs as determined by the investigator. Note: Prior exposure to a biological or a JAK inhibitor treatment for PsA is allowed in =40% of study participants, but not required.
- •8. Patient who is on current treatment with concomitant non-biologic DMARDs at study entry must be on =1 non-biologic DMARDs. The following non-biologic DMARDs are allowed: MTX, sulfasalazine, or leflunomide, and must have been ongoing for =12 weeks and at stable dose for =4 weeks prior to the Randomization Visit. No other DMARDs are permitted during the study.
- •9. Anti-cyclic citrullinated peptide antibodies negative at screening.
- •10. Patient is agreeable to following contraception requirements:
- •o Heterosexually active female patients who are of childbearing potential must use 2 methods of highly effective contraception, 1 of which must be a physical barrier for the duration of the study and for 30 days after the last dose. If they are on a DMARD, they should follow any additional contraception guidance consistent with that product label.
- •o Heterosexually active fertile male patients with a female partner of childbearing potential must agree to use a condom plus another highly effective form of birth control for the duration of the study and for 90 days after the last dose.
- •11. Female patients of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing on Day 1.
- •12. Screening laboratory evaluations (hematology, coagulation, chemistry, and urinalysis) must fall within the normal range of the central laboratory’s reference ranges unless the results have been determined by the investigator to not be clinically significant.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Any arthritis with onset before age 16 years, or current diagnosis of inflammatory joint disease other than PsA, or other immunological disease (including, but not limited to RA, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).
- •2. Current diagnosis of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis, is exclusionary. However, prior history of reactive arthritis or axial spondyloarthritis, including ankylosing spondylitis and nonradiographic axial spondyloarthritis, is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is provided, as determined by the investigator.
- •3. Current diagnosis of fibromyalgia is exclusionary. However, the prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly incorrectly is there, as determined by the investigator.
- •4. Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, e.g., cirrhosis, previous malignancy, previous venous thromboembolism.
- •5. History or evidence of active tuberculosis (TB), irrespective of prior, or current treatment status, or untreated latent TB. Note: Treated latent TB is not an exclusion.
- •6. Positive QuantiFERON®-TB Gold at Screening Visit. If the QuantiFERON®-TB Gold test result is indeterminate, the test should be repeated once. Positive and Indeterminate results exclude the patient unless patient has been treated for latent tuberculosis (documented) and there is no evidence of active tuberculosis (as per investigator’s judgment).
- •7. Known hypersensitivity to zunsemetinib (ATI-450) or any components of the formulation.
- •8. Patient is an alcoholic, or has a history of alcoholism, alcoholic liver disease, or other chronic liver disease.
- •9. Current or any recent (within last 12 months before screening) substance abuse disorder. Note: Marijuana use is allowed if not considered substance abuse by investigator. If a patient uses marijuana, patient should refrain from all marijuana use for 24 hours prior to any study site visit.
- •10. Documented infection or known exposure to an individual with SARS-CoV-2 within 4 weeks before screening.
- •11. A swab test positive for SARS-CoV-2 virus at screening and/or randomization visit.
- •12. Active infection requiring treatment with systemic antibiotics within 4 weeks prior to randomization.
- •13. Positive for HIV, hepatitis B, or C serological tests at screening. Note: Patients with hepatitis B surface antibody without the presence of hepatitis B surface antigen will be allowed to participate. Patients with positive hepatitis C antibody with undetectable hepatitis C viral load can be included in the study if they have been off hepatitis C antiviral treatment for at least 6 months before screening.
- •14. Tests performed at a central laboratory at screening that meet any of the criteria defined in the protocol (out-of-range laboratory tests may be rechecked once, after consultation with the medical monitor, before patient is considered a screen failure).
- •15. Any clinically significant laboratory abnormality that would affect interpretation of study data or safety of the patient’s participation in the study, per judgment of the investigator.
- •16. Clinically significant abnormal
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