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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
.
Medical Information and Product Information Enquiry
medinfo@its.jnj.com
Dr
Andrew
Pink
Atopic dermatitis (AD)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Atopic dermatitis (AD) is a common inflammatory skin condition which causes itchy, dry, red skin.
Biologically, AD is characterized by type-2 immune response dysregulation and skin barrier disruption worsened by the itch-scratch cycle.
JNJ-95475939 blocks the two important biological pathways (called Interleukin-4 [IL-4]/IL-13 and IL-31*) involved in the type-2 inflammation and itch-scratch cycle of AD.
*IL-4, IL-13 and IL-31 are proteins that regulate immune responses.
In this study, researchers want to learn how well JNJ-95475939 works as compared to placebo and a comparator in participants with moderate to severe AD.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab)2. Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study3. Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments4. Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances5. Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum6. History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.7. Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization8. Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Janssen-Cilag International NV and funded by Janssen Research and Development LLC.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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