Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
N/A
N/A
Both
Psoriasis
Trial Information
Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
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 (10 patients).
This double-blind phase will continue for a total of 12 weeks and the principal evaluation
will be the comparison between baseline and 12 week Psoriasis Area Severity Index (PASI)
scores. Patients will come for an initial screening visit at day 0, and at weeks 1, 2, 4,
6, 8, and 12, with follow-up visits at weeks 16 and 20.
All patients will be offered rhIL-10 at 12 weeks (following the blinded portion of the study
protocol). Patients initially receiving active medication who wish to continue rhIL-10
therapy will be kept on the drug. This open-label portion of the study will continue for up
to an additional 12 weeks. Patients continuing with active drug will be evaluated at weeks
14, 16, 20, and 24.
Skin disease activity and toxicity will be assessed and recorded throughout the study. In
addition, research studies will include functional assays to assess cytokine secretion and
immunologic function of peripheral blood cells and immunohistochemical characterization of
the inflammatory cells in skin.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Authority:
United States: Federal Government
Study ID:
990027
NCT ID:
NCT00001797
Start Date:
January 1999
Completion Date:
September 2000
Related Keywords:
- Psoriasis
- Cytokines
- Immunomodulation
- Inflammation
- Skin
- Therapy
- Psoriasis
Name | Location |
|---|---|
| National Cancer Institute (NCI) | Bethesda, Maryland 20892 |
