EUCTR2016-005181-57-DE
Active, not recruiting
Phase 1
A randomized, placebo-controlled, double-blind study to scrutinize the efficacy of Secukinumab in patients with moderate to severe atopic dermatitis - SECU_Trial
ConditionsModerate to serve atopic dermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsCOSENTYX ®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate to serve atopic dermatitis
- Sponsor
- GWT-TUD GmbH
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Atopic dermatitis (intrinsic disease without IgE mediated sensitization defined by negative history and negative SX\-1 CAP FEIA) or extrinsic disease (defined by positive history and / or positive SX\-1 CAP FEIA)\*,
- •2\.SCORAD index score \= 25,
- •3\.EASI \= 16,
- •4\.Male and female patients at the age of 18 to 85 years,
- •5\.Signed Informed Consent,
- •6\.Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed,
- •7\.Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination,
- •8\.Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
- •\*a SX\-1 CAP FEIA report \= 6 months is accepted
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\.Other inflammatory skin disease than atopic dermatitis,
- •2\.Use of cyclosporine, azathioprine, mycophenolate \[wash\-out period of 4 weeks]; Phototherapy (PUVA, NB\-UVB, UVA1; \[wash\-out period of 2 weeks]), Dupilumab (Dupixent®; \[wash\-out period of 12 weeks])
- •3\.Subjects expected to be exposed to an undue safety risk if participating in the trial including chronic infections,
- •4\.Contraindications of Secukinumab by label (i.e. approval for the treatment of psoriasis in the EU – refer to point 12, 13, 16 and 17 at the bottom of this section),
- •5\.Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial,
- •6\.Plans for administration of live vaccines during the study period,
- •7\.Chronic infection,
- •8\.Patients with instable chronic asthma,
- •9\.Any chronic inflammatory bowel disease (e.g. Crohn’s disease),
- •10\.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>10 mIU/mL),
Outcomes
Primary Outcomes
Not specified
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