Dimethylfumarate for the treatment of Palmoplantar Pustulosis

Phase 1

Conditions: Palmoplantar Pustulosis
MedDRA version: 20.0Level: LLTClassification code 10050185Term: Palmoplantar pustulosisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2017-003386-10-AT

Lead Sponsor: Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 25

Inclusion Criteria

- Men or women = 18 years and = 80 years of age at time of screening
- Palmoplantar pustulosis (PPP) for at least 6 months
- moderate - severe disease as defined by a ppPASI score of = 10 for affection of palms and soles, =4 for palms only and =6 for feet only.
- candidates for systemic treatment after failure of topical treatments
- negative serum pregnancy before enrollment and during the study
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- use of prohibited psoriasis treatments
- pregant or nursing women
- WBC count < 3,000 cells/ mm3, lymphocyte count < 1.000/µl
- significant gastrointestinal problems (e.g., ulcer)
- severe renal impairment (eGFR = 30ml/min)
- abnormal liver enzymes
- active infectious diseases
- history of alcohol or intravenous drug abuse
- Immunosuppressive conditions (HIV, organ transplant recipients)
- Known to be hypersensitive to ingredients of the investigational products
- Participation in any other drug investigational trial
- Not willing to give informed consent
- Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Effectiveness of Dimethylfumarate in terms of 75% reduction of the Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI-75 response);Secondary Objective: - Effectiveness of DMF in patients with nail involvement<br>- Health-related quality of life <br>- clinical safety and tolerability ;Primary end point(s): Proportion of patients with a ppPASI-75 response ;Timepoint(s) of evaluation of this end point: week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Objective measures of disease severity: <br>- Mean reduction in ppPASI and logarithmic ppPASI score <br>- Mean reduction in target finger- and toenail Nail Area and Severity Index (NAPSI)<br>- Change in Investigator’s Global Assessment (IGA) for palms, soles, toe- and fingernails<br>- Proportion of patients achieving an IGA of 0 or 1 <br><br>Patient reported outcomes: <br>- Mean reduction in pain- and itch-scale <br>- Mean reduction in Dermatology Life Quality Index (DLQI) <br>- Proportion of patients achieving DLQI 0 or 1 <br>- Global Patient Satisfaction <br>- Change in Subject’s Global Assessment (SGA) for palms/soles and nails <br><br>To evaluate the clinical safety and tolerability of DMF as assessed by clinical laboratory variables and adverse events monitoring<br>;Timepoint(s) of evaluation of this end point: week 24