pilot phase 2 clinical trial performed in some hospitals to evaluate the efficacy and the adverse events in a group of patients with active bullous pemphigoid that will receive DF2156A at the dose of 150 mg, oral route, twice a day.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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