Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001797
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
Status:
COMPLETED
Status Verified Date:
1999-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ugkg 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
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
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 microgkg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0027 | None | None | None |