CTRI/2008/091/000296已完成2 期
A Phase II Study to Evaluate the Safety and Efficacy of anti-CD6 monoclonal antibody (T1h mAb) in Patients with Active Psoriasis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
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
入选标准
- •Age 18-50 years (Both inclusive)
- •Patients with active moderate to severe plaque psoriasis, with or without psoriatic arthropathy and erythroderma, for at least 1 year, involving ≥10% of total body surface area, had failed at least one prior anti-psoriatic therapy and with at least one plaque > 2.5 cm2 for biopsies.
- •Receiving treatment on an outpatient basis.
- •Not currently on retinoic acid treatments.
- •Active disease at the time of screening.
- •Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •Patients must have been treated unsuccessfully with one or more systemic anti-psoriatic treatments.
- •Patients on the following treatments can be included in the study with a washout period of:
- •2 weeks for phototherapy and topical treatments
- •4 weeks for methotrexate
- •4 weeks for cyclosporine
- •4 weeks for retinoic acid therapy
- •4 weeks for Psoralen + UV-A therapy
- •5 half life time periods for other non-biologic anti-psoriatic therapy
- •Glucocorticoids ≤10 mg/day of prednisolone or equivalent permitted if stable for at least 4 weeks prior to baseline.
- •Patients of reproductive potential (males and females), and willing to use reliable means of contraception (e.g. hormonal contraceptive patch, or contraceptive pills or intrauterine device and physical barrier) throughout study participation.
排除标准
- •History of, or current, inflammatory disease (e.g., RA, gout, reactive arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome).
- •Any surgical procedure, within 12 weeks prior to baseline or planned within 24 weeks of enrolment.
- •Any laser dermatological procedure within 12 weeks prior to baseline or planned within 24 weeks of enrolment.
- •Lack of peripheral venous access.
- •Pregnancy or breast feeding.
- •Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
- •Evidence of significant uncontrolled concomitant disease which in the investigator's opinion would preclude patient participation.
- •Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus (HIV) infection.
- •Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with I.V. anti-infective agents within 4 weeks of baseline or completion of oral anti-infective agents within 2 weeks prior to baseline.
- •History of Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis (at screening patients with chest radiograph and history suggestive of tuberculosis will be excluded)
- •History of cancer, including solid tumours, hematologic malignancies and carcinoma in situ,
- •Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g. Parkinson?s disease, cerebral palsy, diabetic neuropathy, multiple sclerosis).
- •Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
- •History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of T1h mAb or to murine proteins.
- •Previous treatment with any approved or investigational biologic agent for psoriasis during the past 1 year
- •Treatment with any investigational agent (non-biologic) within 28 days of baseline or 5 half-lives of the investigational drug (which ever is the longer).
- •Previous treatment with any cell depleting therapies, including investigational agents.
- •Receipt of a live/attenuated vaccine within 28 days prior to baseline (it is recommended that a patient's vaccination record and the need for immunization prior to receiving T1h mAb should be carefully investigated).
- •Parenteral glucocorticoids within 4 weeks prior to baseline.
- •Intolerance or contraindications to i.v. glucocorticoids.
- •Positive tests for hepatitis B surface antigen (HBsAg) or hepatitis
- •C serology.
- •Hemoglobin < 8.0 g/dL.
- •Absolute Neutrophil count (ANC) < 1.5 x 103/uL.
- •CD4+ T cell count < 450 cells/mm3
- •Clinical suspicion of Latent Tuberculosis infection or positive Mantoux test for tuberculosis
研究者
相似试验
进行中（未招募）
2 期
A Phase II Study to Evaluate the Safety and Efficacy of OQL011 in hand and foot skin reaction in Cancer Patients.CTRI/2023/01/048670OnQuality Pharmaceuticals (USA) LLC
尚未招募
2 期
Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR inhibitor-Associated HFSR in Cancer Patients.CTRI/2021/07/034694ONQUALITY PHARMACEUTICALS USA LLC
进行中（未招募）
1 期
A Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination with an mRNA or Vector Vaccine in Patients under Immunosuppressive Therapy no or reduced Responds to Standard mRNA SARS-CoV-2 (Covid-19) VaccinatioVaccination against SARS-CoV-2 in patients with immunosuppressive therapy or immunodeficienciesEUCTR2021-002693-10-ATMedical University of Vienna, Department for Internal Medicine III, Division of Rheumatology300
进行中（未招募）
1 期
Clinical study to review how safe and how effective IMR-687 is in subjects with Sickle Cell DiseaseMedDRA version: 20.0Level: PTClassification code 10043395Term: Thalassaemia sickle cellSystem Organ Class: 10010331 - Congenital, familial and genetic disordersSickle Cell DiseaseEUCTR2019-004471-39-ITIMARA Inc.99
尚未招募
2 期
A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell DiseaseThe population for this study includes subjects with the following forms of SCD: homozygous sickle hemoglobin (HbSS), sickle-ß° (HbSB°) thalassemia, and sickle-ß? (HbSB?) thalassemia.Sickle cellLBCTR2020083421IMARA, Inc.99