CompletedPhase 2

Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis

Germany22 participantsStarted 2018-09-18

Plain-language summary

The overall aim of this study is to assess the effects of a new treatment called Secukinumab in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall support the extension of the approval for Secukinumab from psoriasis to atopic dermatitis. The effectiveness of Secukinumab is determined on the reduction of the eczema score EASI 50 (Eczema Area and Severity Index, a tool to measure the severity of atopic dermatitis) at week 4.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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),
. SCORAD index score ≥ 25,
. EASI ≥ 16,
. Male and female patients at the age of 18 to 85 years,
. Signed Informed Consent,
. 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,
. 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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in EASI

Timeframe: week 4 (visit 4)

Trial details

NCT IDNCT03568136

SponsorGWT-TUD GmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-04

View on ClinicalTrials.gov More Dermatitis, Atopic trials

Plain-language summary

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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),
. SCORAD index score ≥ 25,
. EASI ≥ 16,
. Male and female patients at the age of 18 to 85 years,
. Signed Informed Consent,
. 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,
. 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,

Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria