NL-OMON50746已完成2 期
A randomized, subject and investigator blinded, placebo-controlled, multicenter study in parallel groups to assess the efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne - CLYS006X2201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 8
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
- •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. Electrocardiograms and laboratory tests should be consistent with
- •normal values at screening.
- •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 of 10 non-inflammatory facial lesions (open and closed
- •- 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
- •5. Patients with Grade 3 (moderate) or Grade 4 (severe) IGA score confirmed by
- •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.
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 6 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-TNF* agents, anti-IL-1, or
- •anti-IL-17) within 3 months or 5 half-lives (whichever is longer) prior to
- •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
- •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
- •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. Sexually active males must use a condom during intercourse while taking
- •drug and for 2 weeks after stopping study medication and should not father a
- •child in this period.
- •21. History of drug abuse or unhealthy alcohol use.
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研究者
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