Topics

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

2018-07-02 05:50:14 | BioPortfolio

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.

Description

Secukinumab is a humanized anti-IL-17A monoclonal antibody. Since Secukinumab is well established in the therapy of psoriasis with a highly favorable benefit to risk ration and IL-17 has been described in atopic dermatitis this study aims to investigate the effects of anti-IL-17 in atopic dermatitis.

This is a randomized, placebo-controlled, multicenter, double-blinded study to evaluate the efficacy and safety of subcutaneous Secukinumab compared to placebo in 45 adults with atopic dermatitis.

The study consists of 3 periods: a screening period of at least -28 days and up to -35 days, and a treatment period of 16 weeks and a follow-up period of additional 8 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 2:1 to treatment arm A or B at Day -20 during the randomization visit. Secukinumab (Cosentyx®) will be used according to the official label and SmPC (Summary of Product Characteristics). Patients in treatment arm A receive 300 mg Secukinumab administered as 2 subcutaneous injections of 150 mg (i.e. 2x 150 mg) at baseline day 1 and week 1, 2, 3, 4, 8, 12 and injections with placebo at week 5, 6, 7 and 16. For assessments of the study endpoints were followed up visits at week 20 and 24. Placebo will be administered as 2 subcutaneous injections. Patients in treatment arm B receive placebo until visit 3 (week 3) and will switch to Secukinumab 300 mg s.c. up from visit 4 (week 4), visit 5, 6, 7, 8, 12 and16. For assessments of the study endpoints were followed up visits at week 20 and 24.

Study Design

Conditions

Dermatitis, Atopic

Intervention

Secukinumab 300 mg, Placebo

Location

Carl Gustav Carus University Hospital, Department of Dermatology
Dresden
Germany
01307

Status

Not yet recruiting

Source

GWT-TUD GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-07-02T05:50:14-0400

Clinical Trials [746 Associated Clinical Trials listed on BioPortfolio]

Secukinumab for Treatment of Atopic Dermatitis

Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at lea...

Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients

Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence. Complementary and alternative medical approaches have been employed to relieve symptoms of Atop...

Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic d...

Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE 2)

This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis

This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

PubMed Articles [1365 Associated PubMed Articles listed on BioPortfolio]

Upadacitinib in Adults With Moderate-to-Severe Atopic Dermatitis: 16-Week Results From a Randomized, Placebo-Controlled Trial.

Atopic dermatitis is a chronic inflammatory skin disease characterized by pruritic skin lesions.

Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial.

Atopic dermatitis is associated with substantial patient and caregiver burden. Currently available treatments for atopic dermatitis are inadequate or contraindicated for some patients. Abrocitinib (PF...

Psoriasis-Like Dermatitis Developing in an Atopic Dermatitis Patient Treated With Dupilumab.

Tocopherol Allergic Dermatitis Masquerading as Lifelong Atopic Dermatitis.

Efficacy and safety of So-Cheong-Ryong-Tang in patients with atopic dermatitis and respiratory disorders: Study protocol of a double-blind randomized placebo-controlled trial.

Atopic dermatitis (AD, atopic eczema) is a pruritic, inflammatory, chronic skin disease. Since there is limitation of conventional treatment of AD, traditional herbal medicine can be an attractive the...

Medical and Biotech [MESH] Definitions

A disseminated vesicular-pustular eruption caused by the herpes simplex virus (HERPESVIRUS HOMINIS), the VACCINIA VIRUS, or Varicella zoster (HERPESVIRUS 3, HUMAN). It is usually superimposed on a preexisting, inactive or active, atopic dermatitis (DERMATITIS, ATOPIC).

The widespread involvement of the skin by a scaly, erythematous dermatitis occurring either as a secondary or reactive process to an underlying cutaneous disorder (e.g., atopic dermatitis, psoriasis, etc.), or as a primary or idiopathic disease. It is often associated with the loss of hair and nails, hyperkeratosis of the palms and soles, and pruritus. (From Dorland, 27th ed)

Antigens from the house dust mites (DERMATOPHAGOIDES), mainly D. farinae and D. pteronyssinus. They are proteins, found in mite feces or mite extracts, that can cause ASTHMA and other allergic diseases such as perennial rhinitis (RHINITIS, ALLERGIC, PERENNIAL) and atopic dermatitis (DERMATITIS, ATOPIC). More than 11 groups of Dermatophagoides ALLERGENS have been defined. Group I allergens, such as Der f I and Der p I from the above two species, are among the strongest mite immunogens in humans.

A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.

Rare autosomal recessive disease with variable expressions. Clinical features of the disease include variable ICHTHYOSIFORM ERYTHRODERMA, CONGENITAL; bamboo hair (trichorrhexis invaginata); and ATOPIC DERMATITIS. The disease is caused by mutations in the SPINK5 gene.

More From BioPortfolio on "Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis"

Quick Search

Relevant Topics

Eczema
Eczema is a common itchy skin disease characterized by reddening and vesicle formation, which may lead to weeping and crusting. It is endogenous, or constitutional. There are five main types; atopic, seborrhoeic, discoid, gravitational or varicose. ...

Alzumab (Itolizumab)
Biocon Launches ALZUMAb™ - a ‘First in Class’ Novel Biologic Treatment for Psoriasis Patients in India • ALZUMAb™-World's first novel anti-CD6 antibody developed by Biocon to address a large unmet need for th...

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...


Searches Linking to this Trial