The purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD)

Long-term Safety and Efficacy Evaluation of IMG-007 in Participants With Moderate-to-Severe Atopic Dermatitis

Inmagene

The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Charlotte Office

Anderson Location

Columbus, OH

Ocala, FL

Forest Hills Dermatology Group

Woodbury, NY

Mississauga, Canada

Rolling Meadows, IL

Clinical Operations Department

Saskatoon, Canada

This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks. The study compares how well BFB759 works and how safe it is compared with a placebo.

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

Charlotte, NC

Norfolk Office

Plainfield, IN

Winter Park, FL

NMC Research

Northville, MI

Auburn Hills, MI

Boca Raton, FL

Margate, FL

Elias Dermatology - Fort Lauderdale, FL

North Miami Beach, FL

Wendy Daigle, Director of Clinical Operations

Southshore, Metairie, LA

San Antonio, TX

Calgary, Canada

Vida Dermatology South

Huntington Beach, CA

Sparks Location

Reno - Moana Lane Location

Rocklin, CA

Women´s Health Institute

Prague, Czech Republic

Grodzisk Mazowiecki, Poland

Dupnitsa, Bulgaria

Bluefin Biomedicine, Inc.

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD.

Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide.

The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Find clinical trials for Eczema in Charlotte, NC

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Eczema trials near Charlotte, NC, USA:

Long-term Safety and Efficacy Evaluation of IMG-007 in Participants With Moderate-to-Severe Atopic Dermatitis

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis (ADAPTIVE)

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis (COMPASS 2-AD)

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab (Switch-Up)

Find clinical trials for Eczema in .css-epvm6{white-space:nowrap;}Charlotte, NC

Related conditions:

Eczema trials near Charlotte, NC, USA:

Long-term Safety and Efficacy Evaluation of IMG-007 in Participants With Moderate-to-Severe Atopic Dermatitis

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis (ADAPTIVE)

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis (COMPASS 2-AD)

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab (Switch-Up)

Find clinical trials for Eczema in Charlotte, NC