An investigator-initiated, multi-center, randomized, double-blind, placebo controlled study of Dupilumab to demonstrate efficacy in subjects with nummular eczema
- Conditions
- Subjects with nummular eczemaMedDRA version: 20.0Level: PTClassification code 10012431Term: DermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-003162-41-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
1.Clinically confirmed diagnosis of NE
2.Biopsy-proven, meaning histology consistent with eczema (including PAS-staining)
3.EASI score = 10
4.History of continuous use of topical steroids for the last 8 weeks
5.Age 18-85 years of age, body weight = 40 kg and = 160 kg
6.Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening.
7.History of continuous use of at least mid-potency topical steroids for the last 8 weeks.
8.Age 18-85 years of age, body weight = 40 kg and = 160 kg.
9.Signed informed consent from patient.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1)Permanent severe diseases, especially those affecting the immune system.
2)Pregnancy or breast feeding.
3)Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit, independent from of the cuntaneous dysbiosis found in NE.
4)Treatment with an investigational drug within 8 weeks before the baseline visit*.
5)Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
6)Diagnosed active endoparasitic infections or at high risk of these infections.
7)Evidence of severe renal dysfunction defined as:
- eGFR < 30 ml/min/1,73 m2 (calculated using the cockroft gold formula) at screening (Visit 1)
8)Evidence of significant hepatic disease defined as:
At screening (Visit 1):
- Alkaline phosphatase >3x upper limit of normal (ULN) or alkaline phosphatase >2,5x ULN and total bilirubin > 2xULN
or
- Aspartate transaminase (AST, SGOT]) and alanine transaminase (ALT, SGPT]) > 2.5x upper limit of normal (ULN).
9)Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits.
10)Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins).
11)Inability or unwillingness to undergo repeated punch biopsies.
12)History of allergy to any component of the study medication.
13)Evidence of acute contact dermatitis at screening.
14)Evidence of Zink deficiency defined as Zink level < 20 µg/dL in serum.
15) History of important side effects of medium potency topical corticosteroids (eg, intolerance to treatment, hypersensitivity reactions*, significant skin atrophy, systemic effects), as assessed by the investigator or patient’s treating physician.
16.) =30% of the total lesional surface located on areas of thin skin that cannot be safely treated with medium potency TCS (eg, face, neck, intertriginous areas, genital areas, areas of skin atrophy) at baseline.
17.) Planned or anticipated use of any prohibited medications and procedures during study treatment.
18.) Known history of human immunodeficiency virus (HIV) infection.
19.) Established diagnosis of Hepatitis B viral infection at the time of screening.
20.) Established diagnosis of hepatitis C viral infection at the time of screening.
21.) History of past or current tuberculosis or other mycobacterial infection.
22.) Presence of skin comorbidities that may interfere with study assessments. This includes, but is not limited to, conditions like scabies, seborrheic dermatitis, Cutaneous T cell Lymphoma, Psoriasis, etc.
23.) Malignancy within 5 years of the screening visit excluding local cutaneous squamous cell
24.) Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. Examples include, but are not limited to patients with short life expectancy, patients with major congenital malformations, patients with cardiovascular conditions (eg, major, clinically significant congenital cardiovascular abnormalities), severe renal conditions, hepato-biliary conditions (eg, Child-Pugh class B or C), active major autoimmune diseases (eg, lupus, inflammatory bowel disease etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary, neurological or lymphatic diseases. The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, case report forms [
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Dupilumab in patients with nummular eczema.;Secondary Objective: To asses improvement (Decrease) of disease.;Primary end point(s): Percent change in EASI score from baseline to week 16<br>;Timepoint(s) of evaluation of this end point: Change from baseline (visit 2) to week 16 (visit 10)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Number of Patients Achieving an Improvement (Decrease) in Physician Global Assessment (PGA) by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16<br>Definition of the PGA 5-point scale:<br>Eczema Area and Severity Index (EASI) 50 score at week 16 <br>Significant histological improvement at week 16<br>Change from Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 <br>Change from Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16 <br>Change from Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16 <br>Safety of Dupilumab will be assessed by Evaluating Adverse Events (AEs) ;Timepoint(s) of evaluation of this end point: Change from baseline (visit 2) to week 16 (visit 10)