The primary endpoint is to determine the number of days it takes to achieve a 50% reduction in blister count, and secondary endpoints include a reduction of baseline prednisone dose once the primary endpoint has been achieved. The trial will last for 16 weeks, encompasses 6 clinic visits (including screening), and patients will be compensated $200 for completion of the trial. Blood draws will take place 4 times during the course of the trial.
The Dermatology Clinical Trials Center at Stanford University is recruiting patients for a clinical study using etanercept (Enbrel) administered subcutaneously to treat pemphigus vulgaris. This is a placebo-controlled study, and they plan to enroll 12 patients, 8 of whom will receive active drug. This drug is generally well-tolerated in trials to date, with a common side effect being a reaction at the site of the injection, consisting of redness, pain, swelling or itching.
Patients will be able to continue their current medications for pemphigus vulgaris throughout the course of the trial.
All participants must be at least 18 years of age with a clinical diagnosis of pemphigus vulgaris and at least 6 active blisters or erosions. Neither pregnant nor nursing women will be included in the study. Potential participants will have a screening visit, which will include a physical exam, a review of their medical history and a blood draw, to determine if they are eligible to enroll in the study.
Participants will return for future visits at 0, 2, 4, 8, and 16 weeks, with the potential to withdraw from the study at any time. Each participant will be randomly assigned to receive either etanercept at a dose of 50 mg or placebo injected under the skin (subcutaneously) once a week (by the participant or someone of their choice who the Stanford clinical trial team will train). Eight (8) patients will receive etanercept, and four (4) will receive placebo. If patients do well and are also taking steroids, their current dose of steroids will be tapered. This period of the study will be "blinded," meaning that neither the patient nor the evaluating physician will know whether the patient is receiving the drug or the placebo.
Please contact the Dermatology Clinical Trials department by e-mail or phone with any questions you may have, and feel free to pass on this contact information to other potential participants.
Dr. David Fiorentino
Contact Valerie at 650-724-0385