EUCTR2020-003476-41-PL进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of ANB019 in the Treatment of Subjects withIchthyosis - INSPIRE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •1. Male and female subject aged 12 to 75 years (inclusive) at the time of signing the informed
- •consent/assent.
- •2. Confirmed diagnosis by genetic testing of ichthyosis of one of these subtypes:
- •a) Congenital ichthyosiform erythroderma (autosomal recessive congenital ichthyosis [ARCI]);
- •b) Epidermolytic ichthyosis;
- •c) Netherton syndrome;
- •d) Ichthyosis en confetti;
- •e) Other subtypes may be included (only subtypes in which high levels of IL-36? expression in skin
- •were confirmed by a ribonucleic acid [RNA] analysis [eg, RNA sequencing {RNA-seq},
- •polymerase chain reaction {PCR}] as part of other studies).
- •Note: Confirmation of genetic subtype will be obtained prior to eligibility determination.
- •3. IASI total score = 18, erythema score = 2 (moderate severity) in = 1 body region and scaling score =
- •2 (moderate severity) in = 1 body region as evaluated by IASI, and BSA involved with ichthyosis of at
- •least 50% at Day 1.
- •4. Subject has been using an emollient (without pharmacological active ingredients) daily for at least 1
- •week prior to Day 1 (except within 3 hours prior to the study visit) and agrees to continue using that
- •same emollient daily at the same frequency throughout the study.
- •5. Subject meets the following laboratory criteria at screening:
- •a) Hemoglobin = 90 g/L (= 9 g/dL);
- •b) White blood cell count = 3.0 × 109/L (= 3.0 × 103/µL);
- •c) Platelets = 100 × 109/L (= 100 × 103/µL);
- •d) Serum creatinine <132.6 µmol/L (< 1.5 mg/dL);
- •e) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2 upper limit of
- •normal (ULN);
- •f) Total bilirubin = 1.5 × ULN. Subjects with known Gilbert’s disease who have serum
- •bilirubin < 3 × ULN may be included.
- •6. Body mass index (BMI) within the range of 18 to 38 kg/m2, inclusive {BMI = weight (kg)/[height
- •7. No clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that
- •would, in the opinion of the Investigator, put the subject at undue risk or interfere with
- •interpretation of study results.
- •8. Contraceptive use by men and women should be consistent with local regulations regarding the
- •methods of contraception for those participating in clinical studies.
- •Contraception and pregnancy:
- •a) A male subject must agree to use contraception as detailed in Appendix 1 of this protocol
- •during the treatment period and for at least 220 days (which includes the duration of relevant exposure plus the duration of sperm cycle) after the last study treatment administration and
- •refrain from donating sperm during this period.
- •b) Female subjects:
- •i) A woman of childbearing potential (WOCBP) is eligible to participate if she has a negative
- •serum pregnancy test (beta-human chorionic gonadotropin) at screening and a negative
- •urine pregnancy test at Day 1 (see Appendix 1), is not breastfeeding, and agrees to follow
- •the contraceptive guidance in Appendix 1 during the treatment period and for at least
- •6 months after receiving the study treatment, and refrains from donating oocytes for
- •assisted reproduction during this period. The female subject’s selected form of
- •contraception must be effective by the time the female subject enters into the study at
- •Day 1 (eg, hormonal contraception should be initiated at least 48 days before Day 1).
- •ii) A woman not of childbearing potential as defined in Appendix 1, must have a
- •follicle-stimulating hormone (FSH) test confirming nonchildbearing potential.
- •iii) An adolescent subject who experiences menarche during the trial will be considered a
排除标准
- •1. Concomitant dermatological or medical conditions that may interfere with the Investigators’ ability to evaluate the subject’s response to therapy.
- •2. A subject with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.
- •3. Subject has a history of clinically significant cardiac, pulmonary, neurologic, gastrointestinal, endocrine, hematological, renal, hepatic, cerebral or psychiatric
- •disease, or other major uncontrolled disease.
- •4. Chronic or recurrent infectious disease, including but not limited to upper and lower respiratory infection within 6 months prior to screening.
- •5. History or any evidence of active infection that required systemic treatment within 4 weeks of Day 1, excluding localized oral or genital herpes simplex that, in the opinion of the Investigator, is well-controlled.
- •6. Any factors that would predispose the subject to develop an infection in the Investigator’s opinion.
- •7. Opportunistic infection or parasitic infections within 6 months prior to screening.
- •8. Herpes zoster infection within 2 months prior to screening.
- •9. Known or suspected autoimmune disorder
- •10. History of known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject’s immune status
- •11. Any major surgery within 4 weeks of Day 1.
- •12. History of cancer or lymphoproliferative disease within 5 years prior to Day 1.
- •13. History of any significant drug allergy or reaction and reactivity to polysorbate-20, a component of ANB019 formulation, or the inactive ingredients.
- •14. Subject has taken the following drugs within the specified period prior to Day 1:
- •a) Topical medications within 2 weeks prior to Day 1.
- •b) Topical agents or systemic agents that could affect pruritus within 2 weeks prior to Day 1.
- •c) Oral sedative H1 antihistaminic (including but not limited to diphenhydramine) within 2 weeks prior to Day 1.
- •d) Systemic therapy (including, but not limited to retinoids, cyclosporin, methotrexate,
- •corticosteroids) or any other immunosuppressant or immunomodulation drugs within 4 weeks
- •prior to Day 1.
- •e) Previous treatment with anti-IL-36R, anti-IL-36, anti-tumor necrosis factor (TNF)/
- •IL-12/IL-23/ IL-17, or any other mAbs within 12 weeks or 5 half-lives (whichever is longer) prior
- •f) Any nonbiologic investigational drug within 4 weeks or 5 half-lives, whichever is longer prior to
- •g) Marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is
- •longer) prior to Day 1.
- •h) Antibiotic medication within 4 weeks (topical 1 week and systemic 4 weeks) prior to Day 1.
- •i) Systemic antiviral medication within 4 weeks prior to Day 1.
- •j) Live attenuated vaccine within 12 weeks prior to Day 1.
- •15. Active TB or latent TB infection as indicated by a positive QuantiFERON®-TB Gold test at screening
- •or within 6 months prior to screening (if the test is indeterminate, it can be repeated only once),
- •chest X-ray, and/or clinical examination, or has had active TB disease at any time in the past.
- •16. Clinically significant drug or alcohol abuse in the last year prior to Day 1, or other factors limiting
- •the ability to cooperate and to comply with the study protocol, as determined by the Investigator.
- •17. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant during the
- •study period.
- •18. Subject has any other physical, mental, or medical conditions, which, in the opinion of the
- •Investigator, make study participation inadvisable
研究者
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