JNJ-95597528 for Adults with Moderate to Severe Atopic Dermatitis

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What is this study about?

This clinical trial is being done in adults with Atopic Dermatitis, a long-lasting skin disease that can cause dry, itchy, and inflamed skin. The study is testing JNJ-95597528, given as an injection under the skin, and comparing it with placebo. The purpose of the study is to see how well JNJ-95597528 works and how safe it is for people with moderate to severe disease.

People in the study are assigned by chance to receive different doses of JNJ-95597528 or placebo, and neither the participants nor the study team know which treatment is given during the study. Treatment is given over a period of time, and the skin condition is followed during the study visits. The study is designed to learn whether this medicine may help reduce the signs and symptoms of Atopic Dermatitis.

Who Can Join the Study?

Be an adult, meaning 18 years of age or older, or at least the legal age to give consent where the study is being done.
Be in overall good health apart from the skin condition, based on a physical exam, medical history, vital signs, and a 12-lead ECG (a test that records the heart’s electrical activity).
Have chronic atopic dermatitis with symptoms that started at least 1 year before the screening visit.
Have a disease severity score called EASI of 16 or higher at screening and at Week 0. EASI is a doctor’s scoring system for how severe the skin symptoms are.
Have a doctor’s global assessment score called vIGA-AD of 3 or higher at screening and at Week 0. This is a doctor-rated score of skin severity.
Have at least 10% of the body surface area affected by the skin condition at screening and at Week 0. Body surface area means the amount of skin involved.
Have a recorded history, within the required time before screening, of either not responding well to medicated topical treatments for the skin condition, or being unable to use them safely, or not responding well to systemic therapies (treatments that work throughout the body).
If female, not be pregnant, breastfeeding, or planning to become pregnant during the study and for 12 months after the last dose of the study treatment.
If female and able to become pregnant, have a negative pregnancy test at screening and again at Week 0 before receiving the study treatment, agree to more pregnancy tests, and use at least one highly effective birth control method.
If female and able to become pregnant, follow the study rules for birth control if the risk of pregnancy changes during the study, such as starting sexual activity or becoming able to have periods.
If female, agree not to donate eggs or have eggs stored for future use for assisted reproduction during the study and for 12 months after the last dose.
If male, agree not to father a child during the study and for 12 months after the last dose.
If male, agree not to donate sperm or have sperm stored for future use for assisted reproduction during the study and for 12 months after the last dose.
If male and not had a vasectomy (a surgical procedure to prevent pregnancy), agree to use a barrier method of birth control, such as a condom, during any activity that could lead to pregnancy.
Sign the informed consent form (ICF), which means agreeing to join the study after understanding its purpose and procedures.
If choosing to join an optional substudy, sign a separate informed consent form for that substudy; however, not joining the substudy does not prevent participation in the main study.
Be willing and able to follow the study schedule, treatment plan, laboratory tests, lifestyle rules, and other study procedures.

Who Cannot Join the Study?

Has another active skin disease besides atopic dermatitis (for example, psoriasis), or has an ongoing skin problem such as a skin infection that could affect study results. This includes conditions like eczema herpeticum (a herpes-related skin infection), molluscum contagiosum (a viral skin infection), or impetigo (a contagious skin infection). Mild keratosis pilaris or ichthyosis vulgaris related to atopic dermatitis may not count as an exclusion.
Has a transplanted organ, except for a corneal transplant (transplant of the clear front part of the eye) done more than 12 weeks before the first study treatment.
Has a history of substance abuse or alcohol abuse within the past year.
Has an uncontrolled long-term illness that may need short courses of oral corticosteroids (steroid medicine taken by mouth), including severe, uncontrolled asthma (lung disease), such as 2 or more asthma attacks in the last 12 months that needed steroid treatment or a hospital stay longer than 24 hours.
Has abnormal results on the ECG (a heart tracing test), blood chemistry tests, blood count tests, or urine tests that the investigator thinks could affect safety or study results.
Has a history of long-lasting or repeated infections, such as chronic kidney infection, chronic chest infection, repeated urinary tract infections, fungal infection, mycobacterial infection, or open, draining, infected skin wounds or ulcers.
Has a known or suspected weak immune system, including a history of serious unusual infections such as active tuberculosis (TB), HIV, or other infections that happen often or last a long time, suggesting the immune system is not working normally.
Has a history of lymphoproliferative disease (a condition where white blood cells grow too much), including lymphoma, or a history of monoclonal gammopathy of undetermined significance (an abnormal blood protein condition), or signs that suggest one of these problems, such as swollen lymph nodes or an enlarged spleen.
Has previously received JNJ-95597528.
Did not respond to previous treatment with medicines that block IL-13, IL-4Rα, or IL-4 signals, or had a side effect that required stopping those medicines.
Has a known allergy, intolerance, or serious reaction to JNJ-95597528, its ingredients, any biologic medicine (a medicine made from living cells), or to mouse-derived, chimeric (partly mouse and partly human), or other antibody medicines or pieces of antibodies.
Had a serious infection, such as widespread shingles, blood infection (sepsis), pneumonia, or kidney infection, or was hospitalized or received IV antibiotics (antibiotics given into a vein) for an infection within 8 weeks before screening.
Has taken certain medicines that could affect the study, including:
- B-cell-depleting medicines such as alemtuzumab, ocrelizumab, or rituximab within 26 weeks before the first study dose.
- Other immunomodulating biologic therapies (biologic medicines that change the immune system) that may affect atopic dermatitis, such as dupilumab, tralokinumab, lebrikizumab, nemolizumab, or experimental/investigational treatments, within 12 weeks or 5 half-lives, whichever is longer.
- Systemic immunosuppressive or immunomodulating treatments such as oral or injected corticosteroids, methotrexate, cyclosporine A, azathioprine, or JAK inhibitors (medicines that block a signal used by the immune system).
- Phototherapy (treatment using light).
- Other systemic medicines that could affect atopic dermatitis assessment, including herbal or traditional medicines.
- Nonbiologic experimental or investigational medicines within 4 weeks before the first study dose.
- Topical treatments that could affect atopic dermatitis assessment, including corticosteroids, calcineurin inhibitors, JAK inhibitors, PDE4 inhibitors, bleach baths, aryl hydrocarbon receptor-modulating agents, and herbal or traditional medicines.
- Live virus or live bacterial vaccines within 12 weeks before the first study dose, or longer if the vaccine instructions require it.
Is an employee of the investigator or study site who is directly involved in this study or another study run by the same investigator or site, or is a family member of such an employee or the investigator.
Has any condition that the investigator thinks would not be in the person’s best interest, could harm the person’s well-being, or could make study assessments difficult or unclear.
Had a recent case of eczema herpeticum, herpes zoster (shingles), or impetigo within 8 weeks before screening, or has had repeated eczema herpeticum (2 or more times in life) or impetigo.
Has an active parasitic infection or a high risk of parasitic infection, unless treated before randomization. Randomization means being assigned to a study group by chance.
Has ever tested positive for HIV, or tests positive for HIV at screening.
Tests positive for HBV (hepatitis B virus) or HCV (hepatitis C virus) at screening, or has known liver cirrhosis (permanent scarring of the liver).
Has a current cancer, or had cancer within the past 5 years, except for certain skin cancers and cervical carcinoma in situ (very early abnormal cells in the cervix) that has been considered cured with no return for at least 3 months before the first study dose.
Has a current diagnosis or signs of severe, worsening, or uncontrolled problems with the kidneys, heart, blood vessels, lungs, digestive system, endocrine system (hormone-producing glands), nervous system, blood, joints and connective tissue, mental health, or metabolism (how the body uses energy).
Had major surgery within 8 weeks before screening, has not fully recovered from surgery, or has surgery planned during the study period. Surgery under local anesthesia (medicine that numbs one area) is allowed.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Derma-Study-Center Friedrichshafen GmbH	Friedrichshafen	Germany
ISA Interdisciplinary Study Association GmbH	Berlin	Germany
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR	Blankenfelde-Mahlow	Germany
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Uaeqxfgruojoaewyklrlc Mbfypcla Aox	Munster	Germany
Cztaxvv Bhqnm Kfmiyumqxrf Pxcwokmt Stt z ovno	Gdansk	Poland
Kvtohfnp dty Uklvprbnhyak Mdpreagm Afi	Munich	Germany
Sjarceknjjfxbo az dkl Hthe Gyd	Bramsche	Germany
Sbrebns Cthtgvg Matnvrai Sxa z ojan	Poznan	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	18.05.2026
Poland	Not recruiting	18.05.2026

Trial locations

JNJ-95597528 is the study medicine being tested in this trial. It is given as an injection under the skin. The goal of the trial is to see whether it can help reduce the signs and symptoms of moderate to severe atopic dermatitis, and to check how safe it is for adults who have this skin condition.

Atopic dermatitis – Atopic dermatitis is a long-lasting inflammatory skin disease that causes dry, itchy, and irritated skin. It often begins in childhood but can occur at any age. The skin usually becomes red, rough, and inflamed, and symptoms may come and go in flares. In moderate to severe forms, the affected skin areas are more widespread and the irritation is stronger. Over time, repeated scratching can make the skin thicker and more sensitive.

Trial ID:

2025-523464-20-00

Protocol code:

95597528ADM2001

Trial Phase:

Therapeutic exploratory (Phase II)

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JNJ-95597528 for Adults with Moderate to Severe Atopic Dermatitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?