A phase 2, multicentre, single arm, pilot study to assess the efficacy and the safety of 150 mg twice a day oral DF2156A in patients with active bullous pemphigoid. - DF2156A in bullous pemphigoid

DOMPE' s.p.a.0 个研究点目标入组 12 人开始时间: 2012年3月20日最近更新: 2012年8月28日

适应症

试验速览

暂无简介。

•Consented male and female patients aged >50 years with newly diagnosed or relapsing bullous pemphigoid (clinical diagnosis to be confirmed by direct immunofluorescence and indirect immunofluorescence on salt-spit skin or BP180 and/or BP230 ELISA) will be included. Patients must have mild to moderate active blistering disease (total number of blisters between 1 and 30) whether associated or not with urticarial/eczematous lesions and a modified ABSIS score =50. Patients must be free from any systemic treatments that may affect the course of the disease (off-period prior to enrolment: 3 weeks for steroids, dapsone, tetracyclines, nicotinamide; 3 months for azathioprine, mycofenolate mofetil, cyclophosphamide, methotrexate, intravenous immunoglobulins, immunoadsorption, TNF antagonists; 12 months for rituximab, leflunomide). They must also be free from any topical treatments other than topical antibiotics and antiseptics in the 4 days prior to enrolment.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Patients will be excluded if they have a Karnofsky rating score <40% and a mucosal involvement. Patients who have moderate to severe renal impairment (calculated creatinine clearance < 50 mL/min according to the Cockcroft-Gault formula) or hepatic dysfunction (increased ALT/AST > 3 x upper limit of normal and increased total bilirubin > 3 mg/dL [>51.3 µmol/L]) or hypoalbuminemia (serum albumin < 3 g/dL) or a QTcF > 470 msec or had a myocardial infarction in the previous 6 months will be excluded as well. Patients will be excluded if they are on treatment with phenytoin, warfarin, sulphanylurea hypoglycemics and high dose of amitriptyline (> 50 mg/day); if they have a known hypersensitivity to non-steroidal antiinflammatory drugs; if they received an investigational product in the 12 months prior to enrolment. Also, pregnant or breast feeding women or patients unwilling to use effective contraceptive measures (females and males) will be excluded.

发起方

DOMPE' s.p.a.