JNJ-95597528 for Moderate to Severe Atopic Dermatitis in Adults: A Phase 2b Randomized, Double-blind, Placebo-controlled Dose-ranging Study
- Trial ID
- 2025-523464-20-00
- Protocol
- 95597528ADM2001
- Sponsor
- Janssen Cilag International
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy of atopic dermatitis treatment with JNJ-95597528 compared with placebo in adult participants with moderate to severe disease. This is clinically relevant for determining whether the investigational therapy provides meaningful improvement over placebo in a population with substantial inflammatory skin burden. No secondary objectives were specified.
Participants
The trial enrolled 160 participants with moderate to severe atopic dermatitis. The study population included both female and male participants, and adults aged 18 years or older or at least the legal age of consent in the relevant jurisdiction. Participants were selected on the basis of chronic disease activity and general health status. Eligibility required otherwise healthy status on physical examination, medical history, vital signs, and 12-lead ECG, with abnormalities limited to those consistent with the underlying illness. Participants also had to meet prespecified disease activity criteria, including longstanding atopic dermatitis with onset at least 1 year before screening, a Screening and Week 0 EASI score of at least 16, a vIGA-AD score of at least 3, and involvement of at least 10% body surface area. Relevant prior treatment history was required, including inadequate response or inadvisability to medicated topical therapies or inadequate response to systemic therapies. Participants were also required to be willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle restrictions, and other study procedures. Female and male participants were subject to protocol-specified reproductive precautions during the study and for 12 months after the last dose.
Plans and Procedures
This randomized, double-blind, placebo-controlled, multicenter, dose-ranging Atopic Dermatitis trial evaluates the efficacy and safety of JNJ-95597528 in adult participants with moderate to severe disease. The overall study duration extends from the planned recruitment start in May 2026 to the estimated end date in February 2028. Study participation begins with a screening visit to assess eligibility, including medical history, physical examination, vital signs, 12-lead ECG, disease activity criteria, and pregnancy testing where applicable. Eligible participants then enter the treatment period and undergo scheduled follow-up visits for assessment of efficacy, safety, laboratory tests, and other protocol-required procedures, with the primary efficacy evaluation planned at Week 12. An end-of-study visit is conducted at completion of participation to complete final assessments. The expected individual involvement is approximately 12 weeks for the main treatment period, with additional follow-up as required by the protocol. Early termination may occur for withdrawal of consent, noncompliance with scheduled visits or study procedures, protocol-defined eligibility failure, safety concerns, or other investigator- or sponsor-determined reasons.
Treatment
JNJ-95597528 was administered as a solution for injection by subcutaneous route. The investigational treatment was evaluated in a dose-ranging design, although the source data do not specify the dose level or dosing frequency.
Placebo for JNJ-95597528 was used as the non-experimental comparator. The pharmaceutical form, dose, route, and frequency of administration were not specified in the source data.
The study was conducted as a randomized, double-blind, placebo-controlled trial. The available source data do not provide additional information on dosing schedules or participant compliance monitoring.
Efficacy
Efficacy will be assessed by the proportion of participants achieving EASI 75 at Week 12 in adult participants with moderate to severe atopic dermatitis. The comparison will be made between JNJ-95597528 and placebo.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 1, ≥18 years of age (or at least the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.
- 2, Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
- 3, Meets all the following disease activity criteria: a. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield 2014) with onset of symptoms at least 1 year prior to screening visit, as determined by the investigator through participant interview and/or review of the medical history. b. EASI score ≥16 at the Screening and Week 0; c. vIGA-AD score ≥3 at the Screening and Week 0; d. ≥10% BSA of AD involvement at the Screening and Week 0; e. Documented history (within 6 months before screening) of either inadequate response or inadvisability to medicated topical treatments for AD or inadequate response to systemic therapies (within 12 months before screening).
- 4, A female participant, while enrolled in this study and within 12 months (approximately 355 days) after the last dose of study intervention, must: 1. Not be pregnant, breastfeeding, or plan to become pregnant. 2. Agree to not donate gametes (ie, eggs) or freeze for future use for the purposes of assisted reproduction. 3. Either: a. Not be of childbearing potential OR b. Is of childbearing potential and: • Has a negative highly sensitive (eg, β-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention and agrees to further pregnancy tests. • Practices at least 1 highly effective method of contraception. The investigator must evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. The method selected must meet local/regional regulations/guidelines. Note: If a participant’s childbearing potential changes after start of the study (eg, a premenarchal female participant experiences menarche) or the risk of pregnancy changes (eg, a female participant who is not heterosexually active becomes active, or method of contraception changes), a female participant must begin using a highly effective method of contraception. The investigator is responsible for reviewing medical history, menstrual history, and recent sexual activity to reduce the risk of inclusion of women with an early undetected pregnancy. A male participant, while enrolled in this study and for at least 12 months (approximately 355 days) after the last dose of study intervention, must: 1. Agree not to father a child 2. Agree not to donate sperm or freeze for future use for the purposes of assisted reproduction. 3. Have had a vasectomy OR 4. A male participant who has not had a vasectomy must agree to use a barrier method of birth control (eg, either wear a condom [with spermicidal foam/gel/film/cream/suppository if available in their locale] or a partner with an occlusive cap [diaphragm or cervical/vault caps] plus spermicidal foam/gel/film/cream/suppository if available in their locale) when engaging in any activity that allows for passage of ejaculate to a female of childbearing potential. Male participants must also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.
- 5, Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- 6, If willing to participate in the substudy, must sign a separate ICF for the corresponding substudy(or substudies) (where local regulations permit). Refusal to give consent for the optional substudies does not exclude a participant from participation in the main study.
- 7, Willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle restrictions, and other study procedures.
Exclusion Criteria
- 1, Currently have active skin disease other than AD (eg, psoriasis) or has any ongoing significant skin condition including skin infections (eg, eczema herpeticum, molluscum contagiosum, impetigo), that, according to the investigator, could interfere with efficacy assessments. Note: Concomitant keratosis pilaris or ichthyosis vulgaris associated with AD may not need to be exclusionary
- 10, Serious infection (eg, disseminated herpes zoster, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received IV antibiotics for an infection during the 8 weeks before screening.
- 11, Recent case of eczema herpeticum, herpes zoster, or impetigo within 8 weeks before screening or history of recurrent eczema herpeticum (2 or more in their lifetime) or impetigo.
- 12, Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization.
- 13, History of being HIV antibody-positive, HIV test positive, or tests positive for HIV at screening.
- 14, Tests positive for HBV or HCV infection at screening or known liver cirrhosis.
- 15, Current malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, which is considered cured with no evidence of recurrence for at least 3 months prior to the first administration of study intervention and with minimal risk of recurrence).
- 2, Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- 3, 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. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate.
- 4, Has a transplanted organ (with exception of a corneal transplant >12 weeks before the first administration of study intervention).
- 5, History of substance abuse or alcohol abuse within 1 year before screening.
- 6, Uncontrolled chronic disease that might require bursts of oral corticosteroids including co-morbid,severe, uncontrolled asthma (eg, history of ≥2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for >24 hours).
- In the investigator’s opinion, any clinically significant results from the 12-lead ECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screening visit that would affect interpretation of study data or the participant’s safety in the study.
- History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis, untreated latent tuberculosis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non remitting cystitis), fungal infection (mucocutaneous candidiasis), mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, active TB, nontuberculous mycobacterial infection, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis, HIV) or otherwise recurrent infections of abnormal frequency or prolonged duration despite infection resolution, suggesting an immune-compromised status, as judged by the investigator.
- 16, History of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly.
- 17, Previously received JNJ-95597528
- 18, Experienced primary efficacy failure (no response within 16 weeks) or an AE requiring discontinuation related to agents inhibiting IL-13, IL-4Rα, and IL-4 signaling
- 19, Has known hypersensitivity or intolerance to JNJ-95597528 or its excipients or to any biologic medication or known allergies, or clinically significant reactions to murine, chimeric, mAbs, or antibody fragments
- 20, Received any of the following medications within specified timepoint: # Agents that deplete B cells including but not limited to: alemtuzumab, ocrelizumab, or rituximab received within 26 weeks prior to the first administration of study intervention through EOS #Any immunomodulating biologic therapy that could affect AD including but not limited to: dupilumab, tralokinumab, lebrikizumab, nemolizumab, experimental or investigational therapy (eg, lunsekimig [SAR443765]) received within 12 weeks or 5 half-lives, whichever is longer, prior to the first administration of study intervention through EOS # Systemic immunomodulating/ immunosuppressive treatments including but not limited to: corticosteroids (oral or parenteral) methotrexate, cyclosporine A, azathioprine, JAK inhibitors; Other therapeutic procedures: phototherapy; Systemic medications that could affect AD evaluations including, but not limited to: Herbal treatments, or traditional medicines (eg, Korean, Chinese medicines) ; Nonbiologic experimental therapies or investigational agents received within 4 weeks prior to the first administration of study intervention through EOS # Topical medications/treatments that could affect AD evaluations including, but not limited to: Corticosteroids, calcineurin inhibitors, JAK inhibitors, PDE4 inhibitors; Bleach baths; Aryl hydrocarbon receptor modulating agents ; Herbal treatments or traditional medicines (eg, Korean, Chinese) Note: Corticosteroid inhalers are allowed for stable asthma patients, and use of nasal, otic, ocular, and intra-articular corticosteroids are permitted # Live virus or live bacterial vaccination received within 12 weeks (or longer if required per vaccine package insert) prior to the first administration of study intervention and for approximately 12 months (approximately 355 days) after receiving the last dose of study intervention.
- 21, Employee of the investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employee or the investigator.
- 22, Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Germany | Not Recruiting | 18 May 2026 | 7 |
 Poland | Not Recruiting | 18 May 2026 | 7 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Placebo for JNJ-95597528 | Placebo | N/A | — | — | — | N/A |
JNJ-95597528 | Test | SOLUTION FOR INJECTION | SUBCUTANEOUS USE | 0 | 36 | PRD11790255 |