2025-523464-20-00招募中2 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants with Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 10
- 主要终点
- EASI 75 at Week 12
研究概览
简要总结
To evaluate the efficacy of JNJ-95597528 compared to placebo in participants with moderate to severe AD
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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:
- •Not be pregnant, breastfeeding, or plan to become pregnant.
- •Agree to not donate gametes (ie, eggs) or freeze for future use for the purposes of assisted reproduction.
- •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:
- •Agree not to father a child
- •Agree not to donate sperm or freeze for future use for the purposes of assisted reproduction.
- •Have had a vasectomy OR
- •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.
排除标准
- •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
- •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
- •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.
- •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.
- •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.
研究组 & 干预措施
JNJ-95597528
Test
干预措施: JNJ-95597528 (Drug)
Placebo for JNJ-95597528
Placebo
干预措施: Placebo for JNJ-95597528 (Drug)
结局指标
主要结局
EASI 75 at Week 12
EASI 75 at Week 12
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (10)
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