A phase 3b, interventional, adaptive, clinical trial to evaluate the efficacy and safety of tralokinumab 300 mg every second week monotherapy compared with placebo in subjects with moderate-to-severe atopic hand eczema who are candidates for systemic therapy (ADHAND) - LP0162-2328

EO PHARMA A/S0 个研究点目标入组 402 人开始时间: 2023年9月21日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 402

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•1. Signed and dated informed consent as described in Appendix 1, Section 10.1.3 has been obtained prior to any protocol related procedures., 10. A HESD itch score (weekly average) score of =4 at baseline. The baseline weekly average will be calculated from daily assessments of itch severity during the 7 days immediately preceding the baseline visit (Day -7 to Day -1). A minimum of 4 scores out of the 7 days is required to calculate the baseline average score. - For subjects who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned randomization date, randomization should be postponed until this requirement is met., 11. Subjects who have a documented recent history (within 12 months before the screening visit) of inadequate response to treatment of AHE with topical prescription medications or for whom topical treatments are otherwise medically inadvisable (e.g., due to important side effects or safety risks). - Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to an IGA-AHE score of =2) despite treatment with a daily regimen of TCS of US class =4 (medium to very/ultra-high potency) and Europe class =3 (potent to very potent) (with or without TCI as appropriate), applied for at least 28 days or for the maximum duration recommended by the product prescribing information (e.g., 14 days for super potent TCS), whichever is shorter. - Subjects with documented systemic treatment for AHE in the past year are also considered as inadequate responders to topical treatments and are potentially eligible for enrollment after appropriate wash-out. - Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects, as assessed by the investigator or by the subject’s treating physician., 12. A WOCBP* must use a highly effective** form of birth control throughout the trial and for at least 16 weeks (5 half-lives) after last administration of IMP. * A WOCBP is defined as a female subject aged =12 years who, at the discretion of the investigator, is deemed to be of reproductive potential. A woman is defined as not being of childbearing potential if she is postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). **A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject and not just being without a current partner), same-sex partner, or vasectomized partner (given that the subject is monogamous)., 2. Age 18 years or above at screening., 3. Willingness to comply with the clinical trial protocol. Type of subject and disease characteristics, 4. Diagnosis of AD as defined by the Hanifin and Rajka (44) criteria for AD (Appendix 5, Section 10.5)., 5. Hist

排除标准

•1.Subjects must not enter the trial if they have active subtypes of hand eczema other than AHE that are considered to be the predominant cause of the current hand eczema includinga: -Active irritant contact dermatitis where a relevant exposure to irritants is considered as the predominant cause of the current hand eczema. -Active allergic contact dermatitis where a relevant exposure to allergens is considered as the predominant cause of the current hand eczema; this includes subjects with a positive patch test reactionb within 3 years prior to screening that is deemed to be clinically relevant as the predominant cause of the current hand eczema. -Active protein contact dermatitis/contact urticaria where a relevant exposure to proteins is considered as the predominant cause of the current hand eczema. -Active hyperkeratotic hand eczema considered as the predominant cause of the current hand eczema. -Active vesicular hand eczema (pompholyx) considered as the predominant cause of the current hand eczema. a.Further guidance on classification of hand eczema is provided in Appendix 6 (Section 10.6). b.Patch testing is not a requirement., 10.History of cancer: -Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained. -Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained., 11.History of any known primary immunodeficiency disorder including a positive HIV test at screening., 12.Current or recent chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator., 13.Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, immunological, psychiatric, or major physical impairment that is not stable, in the opinion of the investigator, and could: -Affect the safety of the subject throughout the trial. -Influence the findings of the trial or their interpretations. -Impede the subject’s ability to complete the entire duration of trial., 14.Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during the screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the trial, or may influence the results of the trial, or the subject’s ability to complete the entire duration of the trial., 15.Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), or hepatitis B core antibody (anti-HBc), or hepatitis C virus antibody serology at screening. Subjects with positive anti-HBs are eligible provided that they have a negative HBsAg and negative anti-HBc (blood pattern in vaccinated subjects)., 16.Women who are pregnant or lactating., 17.Treatment with the following medications within 28 days prior to baseline: -Systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporin A, azathioprine, mycophenolate mofetil, JAK inhibitors, retinoids [e.g., alitretinoin]). -Systemic corticosteroid use (excludes topical,

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发起方

EO PHARMA A/S

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