Phase
Condition
Allergy
Rash
Hives (Urticaria)
Treatment
Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Clinically confirmed diagnosis of NE.
- Biopsy-proven, meaning histology consistent with eczema (including PAS-staining).
- EASI score ≥ 10.
- PGA ≥ 3 on a 5 point scale.
- Female patients with reproductive potential must have a negative urine or serumpregnancy test within 7 days prior to start of trial.
- Female participants who are not capable of bearing children or who use a method ofcontraception that is medically approved by the health authority of the respectivecountry at screening. Effective contraception (CTFG guideline) for women ofchildbearing potential should be used throughout the study, including during thefollow-up period or at least 120 days after last dose, whichever is longer (elapse of 4-5 half-lives). The event of pregnancy, Dupilumab should be immediately discontinued.
- History of continuous use of at least mid-potency topical steroids for the last 8weeks.
- Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg.
- Signed informed consent from patient.
Exclusion
Exclusion Criteria:
- Permanent severe diseases, especially those affecting the immune system.
- Pregnancy or breast feeding.
- Active chronic or acute infection requiring systemic treatment within 2 weeks beforethe baseline visit, independent from of the cuntaneous dysbiosis found in NE.
- Treatment with an investigational drug within 8 weeks before the baseline visit.
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
- Diagnosed active endoparasitic infections or at high risk of these infections.
- Evidence of severe renal dysfunction 8.Evidence of significant hepatic disease 9.Patients who are considered potentially unreliable or where it is envisaged thepatient may not consistently attend scheduled study visits. 10.Inability orunwillingness to undergo repeated venipuncture (e.g., because of poor tolerability orlack of access to veins).
11.Inability or unwillingness to undergo repeated punch biopsies. 12.History of allergy toany component of the study medication. 13.Evidence of acute contact dermatitis atscreening. 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, systemiceffects), 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 safelytreated with medium potency TCS (eg, face, neck, intertriginous areas, genital areas, areasof skin atrophy) at baseline. 17. Planned or anticipated use of any prohibited medications and procedures during studytreatment. 18. Known history of human immunodeficiency virus (HIV) infection. 19. Establisheddiagnosis 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. Presenceof skin comorbidities that may interfere with study assessments. 23. Malignancy within 5years of the screening visit excluding local cutaneous squamous cell 24. Severe concomitantillness(es) 25. Any other medical or psychological condition including relevant laboratoryabnormalities at Screening 26. Planned major surgical procedure during the patient'sparticipation in this study.
Study Design
Study Description
Connect with a study center
Klinikum re. Isar Dermatology
München, Bayern 81675
GermanyActive - Recruiting
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