None listed
Conditions
Interventions
Intervention1: T1h mAb: 3 doses. Total duration of participation in the study 32 weeks
Control Intervention1: Nil: Nil
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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. PASI ≥10 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability at 8 weeks Pharmacokinetic analysis of T1h mAb Timepoint: Described under outcome names | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in PASI 50, PASI 75 and PASI 90 scores at 8 weeks, and 12 weeks Improvement in PGA (Physician?s Global Psoriasis Assessment) scores at 8 and 12 weeks Improvement in Psoriasis Severity Scale (PSS) at 8 and 12 weeks. Change in the health-related quality of life assessed by the SF-36 at 8 and 12 weeks Change in health related quality of life assessed by the DLQI (Dermatology Life Quality Index) at 8 and 12 weeks. Reduction in T cell infiltration, and epidermal thicknessTimepoint: Described under Outcomes section | — |
Countries
India
Contacts
Public ContactAbhijit Sharma
Outcome results
None listed