CTRI/2008/091/000296
Completed
Phase 2
A Phase II Study to Evaluate the Safety and Efficacy of anti-CD6 monoclonal antibody (T1h mAb) in Patients with Active Psoriasis.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biocon Limited
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
- •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
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)
Outcomes
Primary Outcomes
Not specified
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