active bullous pemphigoid MedDRA version: 14.0 Level: LLT Classification code 10006567 Term: Bullous pemphigoid System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: not applicable
Product Code: DF2156A
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ladarixin
CAS Number: 865625-56-5
Current Sponsor code: DF2156A
Concentration unit: mg millig
Sponsors
Dompé s.p.a.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria. - Male and female patients aged >50 years. - Patients with newly diagnosed or relapsing bullous pemphigoid based on clinical diagnosis to be confirmed by direct immunofluorescence and indirect immunofluorescence on salt-spit skin (or BP180 and/or BP230 ELISA). Confirmation by laboratory tests will be obtained ideally before or anyway within one week after enrolment. For the purpose of this study, clinical relapses are defined as re-appearance of clinical symptoms after the patient had attained remission lasting for more than 3 months without immunosuppressive treatment. In patients with relapsing BP, clinical diagnosis will be confirmed by indirect immunofluorescence or BP180 and/or BP230 ELISA only. - Patients with mild to moderate active blistering disease (total number of blisters between 1 and 30) whether associated or not with urticarial/eczematous lesions. - Patients with modified ABSIS score =50 - Patients free from any systemic treatments that may affect the course of the disease with the following off-period prior to enrolment: - 3 weeks: steroids, dapsone, tetracyclines, nicotinamide, - 3 months: azathioprine, mycofenolate mofetil, cyclophosphamide, methotrexate, intravenous immunoglobulins, immunoadsorption, TNF antagonists - 12 months: rituximab, leflunomide - Patients free from any topical treatments other than topical antibiotics and antiseptics in the 4 days prior to enrolment. - Patients able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations. - Patients able to provide informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 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
Exclusion criteria: - Patients with a Karnofsky rating score 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 µmol/L]. - Patients with hypoalbuminemia defined as serum albumin 470 msec. - Patients who had a myocardial infarction in the 6 months prior to enrolment. - Patients on treatment with phenytoin, warfarin, sulphanylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose of amitriptyline (> 50 mg/day). - Patients with known hypersensitivity to non-steroidal antiinflammatory drugs. - Patients using any investigational agent within 12 months prior to enrolment. - Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males). Patients with hypokalemia defined as serum potassium < 3.5 mmol/L. - Patients with clinically relevant bradycardia (heart rate < 50 beats/min) - Patients with a complete left bundle branch block. - Patients with a history of uncontrolled or labile hypertension - Patients with a history of congestive heart failure. - Patients with a history of cardiomiopathy. - Patients with unstable angina pectoris - Patients with a personal or family history of congenital or documented acquired QT interval prolongation - Patients with a significant atrial or ventricular arrhythmia or symptomatic arrhythmia in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this clinical trial is to evaluate whether DF2156A has a potential in improving the clinical outcome in patients with active blistering BP to warrant its further development. The safety of DF2156A in the specific clinical setting will be also evaluated.;Secondary Objective: Not applicable;Primary end point(s): Total number of blisters and percent change from baseline; Modified ABSIS score and percent change from baseline; Physician Global Assessment (PGA) score measured on a 0-10 scale; Absolute value and % change from baseline; Pruritus measured on a 10 cm visual analogue scale. Absolute value and percent change from baseline; Eosinophil blood count. Absolute number and percent change from baseline; Number and percentage of patients with treatment failure (drug discontinuation due to disease worsening); Number and percentage of patients completely free from blisters; Number of patients who are still free from blisters without requiring any systemic or topical rescue treatment - Optional;Timepoint(s) of evaluation of this end point: time frame: day 0/1 (predose), 8 and 15; time frame: day 0/1 (predose), 8 and 15; time frame: day 0/1 (predose), 8 and 15; time frame: screenitime frame: day 8ng and day 15; time frame: day 8; time frame: day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Germany, Italy
Contacts
Public ContactDevelopment Project Management
Dompé s.p.a.
Outcome results
None listed