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

March 3, 2008 updated by: National Cancer Institute (NCI)

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 ug/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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Study Completion

September 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (ESTIMATE)

December 10, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

December 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 990027
  • 99-C-0027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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