Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

Several studies have documented an essential role for interleukin-10 (IL-10) in preventing prolonged and exaggerated immune responses to antigens and irritants. Psoriasis, a relatively common disease, is characterized by T cell-mediated inflammation in affected skin. In this study, the safety, tolerance, immunologic effects, and clinical activity of subcutaneous (SC) recombinant human (rh) IL-10 will be evaluated in patients with moderate-to-severe psoriasis. There will be 2 groups of patients, randomized to receive either 20 (micro)g/kg rhIL-10 SC 3 times weekly (20 patients) or SC placebo...

Gender

ALL

Eligibility criteria

• • Able to provide informed consent to all aspects of the study after full information is provided.
• • Age equal to or between 18 and 65 years.
• • Moderate-to-severe stable plaque psoriasis of at least 6 months duration as defined by the following criteria: 1) Classic psoriatic skin lesions with or without nail involvement, 2) Psoriasis Area and Severity Index score greater than 10(i), 3) Total body surface area involved greater than 10%.
• • Weight less than 242 pounds.
• • Must be able to self-administer medication (subcutaneous injection) or arrange for administration.
• • No unstable psoriatic disease, including erythrodermic, pustular, and palmar/plantar variants.
• • No use of topical medications for psoriasis (except for bland emollients) during 2 weeks prior to study entry.
• • No use of systemic medications for psoriasis during 1 month prior to study entry.
• • No patients with an ECOG or Zubrod Performance Status Scale greater than 2.
• • No patients with acute or chronic infections requiring antimicrobial therapy or serious viral (e.g., hepatitis, herpes zoster, or HIV) or fungal infections as the effects of IL-10 on the immune system not completely elucidated and treatment could pose additional risk to the patient. Patients with a positive PPD who have not received antituberculous therapy may be excluded, if in the opinion of an infectious consultant, IL-10 treatment is contraindicated.
• • No patients receiving disease modifying anti-inflammatory drugs (methotrexate, sulfasalazine, gold, hydroxychloroquine, cyclosporin, azathioprine, cyclophosphamide, chlorambucil, retinoids, vitamin D). Such drugs will be discontinued at least 4 weeks prior to randomization.
• • No pregnant females, nursing mothers, or patients of childbearing age not practicing birth control, since the risks to the unborn fetus and newborn child are unknown.
• • No previous history of malignancy or current malignancy other than satisfactorily treated basal-squamous cell carcinoma or in situ cervical carcinoma.
• • No confounding medical illness that in the judgment of the investigators would pose added risk for study participants (e.g., hepatic, hematologic \[e.g., hematocrit less than or equal to 28% or platelet counts less than 100,000/ml\], neurologic, renal, or pulmonary disease).
• • No patients with serum creatinine greater than 1.8 or creatinine clearance (CrCl) less than 50 ml/min.
• • No patients with abnormal liver function tests (e.g., serum glumatic oxalacetic transaminase, serum glutamic pyruvic transaminase or alkaline phosphatase levels greater than 2.5x upper limit of normal (UNL) and/or bilirubin levels 1.5x UNL).
• • No current alcohol or drug abuse.