NL-OMON51714已完成不适用
A First-in-Human, Double-Blind, Randomised, Vehicle-Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients with Mild to Moderate Atopic Dermatitis. - BEN2293 in patients with Mild to Moderate AD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
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 99（—）
入选标准
- •Patients meeting the following criteria will be included in the study:
- •1. Males and females with mild to moderate AD (based on vIGA) free from other
- •clinically significant illness or disease that may adversely affect the safety
- •of the patient or the integrity of the study as determined by medical history,
- •physical examination, safety laboratory and other assessments.
- •2. Willing and able to comply with scheduled visits, treatment plan, laboratory
- •tests and other study procedures.
- •3. Patient is aged between 18 to 65 years, inclusive.
- •4. Patient has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
- •5. Body weight of >=50 kg.
- •6. History of AD for at least 6 months diagnosed by a dermatologist or GP.
- •7. Previous or current successful treatment with topical corticosteroids.
- •8. A vIGA score of 2 (mild) to 3 (moderate) at both Screening and Day -1 (Part
- •A) and at Screening, Day -3 and Day 1 (Part B).
- •9. Atopic dermatitis affecting between >=1% to <=30% BSA of treatable skin (not
- •including face, scalp, genital area, palms of hands or soles of feet) at
- •Screening and Day -1 for all cohorts in Part A and at Screening, Day -3 and Day
- •1 for Part B.
- •10. History of AD associated pruritus with an itch score (NRS) of >=4.
- •· For Part A, the mean of the pruritus NRS scores (worst itch over the last 24
- •hours) obtained on Day -3, Day -2 and Day -1 during the emollient only washout
- •phase will be used to assess inclusion.
- •· For Part B, the mean of the pruritus NRS scores (worst itch over the last 24
- •hours) obtained on Day -5, Day -4 and Day -3 (pre-dose) during the emollient
- •only washout phase, and the mean of these scores on each day of the run-in
- •phase (Day -2, Day -1 and Day 1 [pre-dose]) will be used to assess
- •inclusion at Day -3 and Day 1, respectively. Where the run-in phase is extended
- •by 1 day, the mean NRS for all NRS scores reported over that time (minimum of
- •3) will be used to determine eligibility. Where patients are unable to provide
- •3 consecutive days of NRS scores for calculation of the average score to
- •determine eligibility, a minimum of 3 scores taken over a maximum of 4 days
- •will be used to calculate the average.
- •11. Patients must be willing to stop applying their daily emollients and
- •instead use the study emollient and shower cream from at least 7 days prior to
- •Day 1 in Part A and 10 days prior to Day 1 in Part B, and throughout their
- •participation in the study.
- •12. Males must use a condom during the trial and for 3 months after their final
- •dose study medication. In addition, their female partner of child-bearing
- •potential must be established on an additional method of highly effective
- •contraception (see Section 6.3.1) prior to dosing until 3 months following
- •final dosing.
- •13. Female patients of child-bearing potential must be established on a highly
- •effective method of contraception prior to dosing until 3 months after last
- •dose (see Section 6.3.1 for highly effective method of contraception) in
- •combination with male partner*s use of a condom during the trial and for 3
- •months after the last dose.
- •14. Female patients must have a negative pregnancy test at Screening and Day -1
- •(Part A only) and at Screening, Day -3 and Day 1 (Part B only).
- •15. Participant has a minimum of one AD area in a site suitable for biopsy.
- •16. Written informed consent, which includes
排除标准
- •Patients with any of the following will be excluded from study participation:
- •1. Atopic dermatitis of such severity that the patient could not comply with
- •the demands of the study and/or the patient is not a suitable candidate for a
- •placebo-controlled study, as per Investigator*s discretion.
- •2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including
- •excessive UV exposure, at the possible IMP application sites.
- •3. Patients who have AD lesions affecting >3% untreatable areas (face, scalp,
- •genitals, palms of hands or soles of feet) (Cohorts 3 and 4 in Part A and Part
- •4. Patients who have a source of itch solely or significantly from untreatable
- •areas (face, scalp, genitals, palms of hands or soles of feet) (Cohorts 3 and 4
- •in Part A and Part B only).
- •5. Have concomitant skin disease or infection (e.g., acne, impetigo) or
- •presence of skin comorbidities in the study area to be dosed that may interfere
- •with study assessments.
- •6. Patients who are excessively hirsute in areas of skin to be dosed with study
- •7. Patients who are unwilling to stop hair removal by any means (including
- •shaving, waxing or depilatory creams) to skin areas to be dosed with study
- •ointment for 2 weeks prior to Day -1 and throughout the duration of the study.
- •8. History of drug and/or alcohol abuse within the last 2 years, or intake of
- •>21 units of alcohol weekly, or a positive alcohol breath test at Screening or
- •Day -1 (Part A) and at Screening, Day -3 or Day 1 (Part B). One unit is
- •equivalent to a 285 mL glass of full-strength beer or one (30 mL) measure of
- •spirits or one small glass (100 mL) of wine.
- •9. Regular use of tobacco and/or nicotine containing products within 3 months
- •of Day 1, until the end of the study. Social smokers may be included in the
- •study as long as they are able to abstain from smoking/vaping during
- •residential stays (Part A only). Patients with a positive urine cotinine test
- •at Screening or Day -1 will not be eligible (Part A only). Use of tobacco
- •and/or nicotine containing products (up to 20 cigarettes per day, or
- •equivalent) is permitted for patients in Part B.
- •10. Clinically relevant history of abnormal physical or mental health
- •interfering with the study as determined by medical history and physical
- •examinations as judged by the Investigator (including [but not limited to],
- •neurological, psychiatric, endocrine, cardiovascular, gastrointestinal,
- •hepatic, or renal disorder).
- •11. Positive urine test for drugs of abuse at Screening or Day -1 (Part A) and
- •at Screening or Day -3 (Part B).
- •12. Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C
- •antibody (anti-HCV), human immunodeficiency virus I and II (anti-HIV I/II) or
- •SARS-CoV-2 at Screening.
- •13. Clinically relevant abnormal laboratory results (including hepatic and
- •renal panels, complete blood count, chemistry panel and urinalysis), 12-lead
- •ECG and vital signs, or physical findings at Screening or Day -1 (Part A) and
- •at Screening or Day -3 (Part B). In case of uncertain or questionable results,
- •tests performed during Screening, Day -1 or Day -3 may be repeated once to
- •confirm eligibility or judged to be clinically irrelevant.
- •14. Part B only: Patients treated within 28 days of Day 1 with tricyclic
- •antidepressants (e.g., amitriptyline), anticonvulsants (e.g., carbam
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