EUCTR2017-003191-30-HU进行中（未招募）1 期
A randomized, subject and investigator blinded, placebo-controlled, multi-center study in parallel groups to assess the efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The patients eligible for inclusion in this study must fulfill all of the following criteria:
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Male and female subjects aged 18 to 45 years of age inclusive, and otherwise in good health as determined by medical history, physical examination, and vital signs.
- •3. Body weight between 50 and 120 kg, both inclusive, at screening.
- •4. Patients with papulo-pustular acne vulgaris (inflammatory acne):
- •- presenting at baseline with :
- •20 to 100 facial inflammatory lesions (papules, pustules and nodules),
- •presenting at baseline and screening with
- •no more than 2 facial inflammatory nodules or cysts,
- •and a minimum number of 10 non-inflammatory facial lesions (open and closed comedones)
- •- who are candidates for systemic treatment and for whom in the opinion of the investigator, an appropriate previous treatment with topical anti-acne medication :
- •or was not well tolerated,
- •or is not indicated (e.g., due to large body surface area affected, e.g., on the back)
- •5. Patients with Grade 3 (moderate) or Grade 4 (severe) IGA score confirmed by central reading of standardized image capture (Visia® system) by an independent dermatologist at screening and by the investigator’s clinical evaluation at baseline.
- •6. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •1. Previous treatment with investigational drugs at the time of screening, or within 4 weeks or 5 half-lives of baseline, whichever is longer; or more as required by local regulations.
- •2. Previous treatment with any topical anti-acne therapy:
- •prescription treatment within 2 weeks prior to baseline
- •OTC within 1 week prior to baseline
- •The use of medicated anti-acne creams, medicated cleansers or medicated soaps is prohibited.
- •3. Previous treatment with any oral/systemic anti-acne therapy:
- •oral antibiotics, dapsone, oral zinc within 4 weeks prior to baseline,
- •retinoids, within 3 months prior to baseline and
- •hormonal therapy (within 1 month prior to baseline.
- •If women of child bearing potential are using oral contraception, this contraception can be used under certain conditions.
- •4. Previous treatment with systemic corticosteroids or immunomodulators (e.g. cyclosporine, methotrexate, azathioprine) within 4 weeks prior to baseline.
- •5. Previous treatment with biologics (e.g anti-TNFa agents, anti-IL-1, or anti-IL-17) within 3 months or 5 half-lives (whichever is longer) prior to baseline.
- •6. Previous treatment with anti-IL-12/23 blocking agents (e.g. briakinumab and ustekinumab or p19 antibodies) within 6 months prior to baseline.
- •7. Previous surgical, physical (such as ThermaClear™), light (including blue or UV light, photodynamic therapy) or laser therapy within 4 weeks prior to baseline.
- •8. Previous facial treatment with medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
- •9. Concomitant medication(s) known to inhibit OAT3 or BCRP and that cannot be discontinued or replaced by safe alternative medication within 5 half-lives or 1 week (whichever is longer) to baseline and for the duration of the study.
- •10. Any other forms of acne.
- •11. Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
- •12. Active systemic infections (other than common cold) within 2 weeks prior to baseline.
- •13. Subjects with eGFR <60 mL/min/1.73m2 at screening.
- •14. History or presence of crystals or stones in urine.
- •15. History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
- •16. Chronic infection with Hepatitis B or C.
- •17. History of auto-immune or immunodeficiency diseases, or a positive HIV test result at screening.
- •18. Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •19. Women of child-bearing potential, unless they are using basic methods of contraception during dosing of study treatment.
- •20. History of drug abuse or unhealthy alcohol use.
- •21. Donation or loss of 400 ml or more of blood within 8 weeks prior to baseline, or longer if required by local regulation.
- •22. Inability or unwillingness to undergo repeated venipunctures.
- •23. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
- •Other protocol-defined exclusion criteria may apply.
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