PsoriasisPhase 2NCT00001797
Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
A Phase 2 study testing Recombinant human interleukin-10 in people with Psoriasis, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- What is being tested?
- Recombinant human interleukin-10
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Sep 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Recombinant human interleukin-10
- Keywords
- Cytokines, Immunomodulation, Inflammation, Skin, Therapy
- Medical subject headings
- Psoriasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human interleukin-10Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJan 1999
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001797
- Sponsor's protocol ID
- 990027
- Other IDs
- 99-C-0027
- Status last verified
- Dec 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Uyemura K, Yamamura M, Fivenson DF, Modlin RL, Nickoloff BJ. The cytokine network in lesional and lesion-free psoriatic skin is characterized by a T-helper type 1 cell-mediated response. J Invest Dermatol. 1993 Nov;101(5):701-5. doi: 10.1111/1523-1747.ep12371679.
PubMed 7693825Schlaak JF, Buslau M, Jochum W, Hermann E, Girndt M, Gallati H, Meyer zum Buschenfelde KH, Fleischer B. T cells involved in psoriasis vulgaris belong to the Th1 subset. J Invest Dermatol. 1994 Feb;102(2):145-9. doi: 10.1111/1523-1747.ep12371752.
PubMed 8106745Nestle FO, Turka LA, Nickoloff BJ. Characterization of dermal dendritic cells in psoriasis. Autostimulation of T lymphocytes and induction of Th1 type cytokines. J Clin Invest. 1994 Jul;94(1):202-9. doi: 10.1172/JCI117308.
PubMed 8040262
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00001797
- Acronym / sponsor ID
- 990027
- Conditions
- Psoriasis
- Keywords
- Cytokines, Immunomodulation, Inflammation, Skin, Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 1999
- Study completion
- Sep 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human interleukin-10 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7693825Uyemura K, Yamamura M, Fivenson DF, Modlin RL, Nickoloff BJ. The cytokine network in lesional and lesion-free psoriatic skin is characterized by a T-helper type 1 cell-mediated response. J Invest Dermatol. 1993 Nov;101(5):701-5. doi: 10.1111/1523-1747.ep12371679.
- Background: PubMed 8106745Schlaak JF, Buslau M, Jochum W, Hermann E, Girndt M, Gallati H, Meyer zum Buschenfelde KH, Fleischer B. T cells involved in psoriasis vulgaris belong to the Th1 subset. J Invest Dermatol. 1994 Feb;102(2):145-9. doi: 10.1111/1523-1747.ep12371752.
- Background: PubMed 8040262Nestle FO, Turka LA, Nickoloff BJ. Characterization of dermal dendritic cells in psoriasis. Autostimulation of T lymphocytes and induction of Th1 type cytokines. J Clin Invest. 1994 Jul;94(1):202-9. doi: 10.1172/JCI117308.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human interleukin-10 in people with Psoriasis, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001797, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008; AzTrials last refreshed its copy on 31 Oct 2026.