Clinical trial · Interventional
Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet
Double-blind, Randomized, Placebo-controlled Study of Recombinant Human Tumor Necrosis Factor Receptor (p75) Fusion Protein Etanercept (Enbrel) in Patients With Moderate to Severe Plaque Psoriasis of the Hands and/or Feet
NCT00585650CI-TRIAL-00068870completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etanercept | Biological | — | UNRESOLVED |
| Placebo injections | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Etanercept (Enbrel) 50mg twice weekly injections for 12 weeks
- interventionNames
- Biological: Etanercept
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Placebo Injections twice weekly for 12 weeks
- interventionNames
- Other: Placebo injections
Primary outcomes (1)
- measure
- The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks.
- timeFrame
- Week 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Moderate to severe palmar plantar psoriasis based on physician's global assessment (PGA). * Between 18 and 70 years of age * Negative urine pregnancy test at screening and at baseline * Sexually active men and women of child-bearing potential must agree to use a medically accepted form of contraception (birth control) during the exclusionary medicine wash-out period and throughout the study. * Ability to self inject study drug or have a designee who can do so * Capable of understanding and giving written voluntary informed consent Exclusion Criteria: * Previous treatment with Enbrel® (etanercept) or similar drugs * Receipt of investigational drugs or "biologics" within 4 weeks of the screening visit. * Evidence of skin conditions (e.g. eczema) other than psoriasis that would interfere with evaluations of the study medication. * Receipt of any biologic medication within the previous 6 months that resulted in a decreased white blood cell count (cells to help fight infections) * Ultraviolet light treatment (e.g. UVB, PUVA) within one month prior to study drug initiation. * Receipt of immune-suppressing drugs other than Rheumatrex® (methotrexate) or Soriatane® (acetretin) within 4 weeks prior to the first dose of study drug. Medications you would not be allowed to take during this study include for example, Cytoxan® (cyclosporine), Imuran® (azathioprine), or Sulfazine® (sulfasalazine). If you remain on Rheumatrex® (methotrexate) (≤25 mg/week) or Soriatane® (acitretin) (≤50 mg/day), you must be considered to have inadequate disease control in the opinion of the investigator based on physician's global assessment. You must have been on a stable dose of systemic treatment for at least 1 month prior to the start of the study medication. You will be required to maintain a stable dose of the systemic treatment throughout the study. * Use of topical steroids in the past 14 days unless they have been used for longer than 14 days and the severity of disease allows entry into study. * Systemic steroid use (prednisone, etc). * Prior or concurrent use of Cytoxan® (cyclophosphamide). * Elevated liver tests; red blood cell count less than normal; decreased platelet count (cells to help with blood clotting); decreased white blood cell count (cells to fight infection); kidney insufficiency * Any severe adverse event, infection or abnormal laboratory value at the time of the screening visit that would preclude participation in the study * Presence of a severe infection, less than 30 days prior to the screening visit or between the screening visit and the first dose of study drug * Pregnant or breast-feeding females. * Significant concurrent medical diseases including: Uncompensated congestive heart failure (heart is unable to pump as normal): Myocardial infarction (heart attack) within 12 months of screening period; Unstable or stable angina pectoris (chest pains related to your heart); Uncontrolled high blood pressure * Severe lung disease requiring medical or oxygen therapy * History of cancer (other than surgically removed skin cancer and in situ cervical cancer) within 5 years of the screening visit * History of tuberculosis * Known to be HIV positive * Rheumatoid arthritis * Any neurologic demyelinating disease (such as multiple sclerosis or any neurologic disease causing loss of sensation or loss of normal movement) or seizure disorder * Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent. * History of alcohol or drug abuse. * Not up-to-date with all immunizations in agreement with the current immunization guidelines * Significant exposure to the varicella virus (chicken pox) * Guttate or generalized pustular psoriasis * Surgery or trauma within a month of baseline considered by the investigator to represent a significant risk or interfere with patient evaluation.
References
Publications (0)
Data not yet available
No reference posted for this study.