2024-517814-13-00招募中2 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Dose ranging Study to Evaluate the Efficacy and Safety of JNJ-95475939 for the Treatment of Participants with Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 26
- 主要终点
- EASI 75 at Week 12
研究概览
简要总结
To evaluate the efficacy of JNJ 95475939 relative 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
- 是
入选标准
- •≥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.
- •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.
- •Meets all the disease activity criteria as stated in the protocol: 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 Baseline Visits; c. vIGA-AD score ≥3 at the Screening and Baseline Visits; d. ≥10% BSA of AD involvement at the Screening and Baseline Visits; e. Baseline PP-NRS average score of ≥4 (Protocol Section 8.2.1.1). f. Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening) g. Participant has applied a moisturizer at least once daily for at least 7 days before the Baseline Visit.
- •A female participant, while enrolled in this study or within 98 days (14 weeks) after the last dose of study intervention, must: a. Agree to not be pregnant, breastfeeding, or plan to become pregnant. b. Agree to not donate gametes (ie, eggs) or freeze for future use for the purposes of assisted reproduction. c. Either not of childbearing potential (as defined in Section 10.4), or if of childbearing potential: 1) have 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 agree to further pregnancy tests. 2) practice 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. a. A female participant using oral contraceptives must use an additional contraceptive method
- •A male participant, while enrolled in this study and for at least 98 days (14 weeks) after the last dose of study intervention, must: a. Agree not to plan to father a child b. Agree not to donate sperm or freeze for future use for the purposes of assisted reproduction. c. 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 during the study and for 98 days (14 weeks) after the last dose of study intervention. 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.
排除标准
- •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 assessments.
- •Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- •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.
- •Has a transplanted organ (with exception of a corneal transplant >12 weeks before the first administration of study intervention).
- •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).
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 (26)
Loading locations...
相似试验
招募中
2 期
Efficacy and Safety of JNJ-77242113 in Participants with Moderately to Severely Active Ulcerative ColitisUlcerative Colitis2023-504673-20-00Janssen - Cilag International102
招募中
2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study with a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease2022-501188-42-00Janssen - Cilag International195
招募中
2 期
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple MyelomaMultiple MyelomaNCT07266441Janssen Research & Development, LLC157
招募中
2 期
Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis2023-504743-13-00Janssen - Cilag International383
招募中
2 期
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current ManiaManiaBipolar I DisorderNCT07288320Neurocrine Biosciences150