A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects with Palmoplantar Pustulosis

AnaptysBio Inc0 个研究点目标入组 59 人开始时间: 2020年1月27日最近更新: 2021年5月17日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AnaptysBio Inc
入组人数: 59

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male and female subjects must be 18 to 75 years of age (inclusive), at the time of signing the informed consent.
•2. Clinically confirmed diagnosis of PPP with disease of sufficient Impact and severity requiring systemic therapy.
•3. Disease duration of at least 3 months prior to Screening.
•4. Present with active pustules on palms or/and soles at Screening and Baseline.
•5. At least moderate disease severity (score 3 = moderate) based on the PPPIGA (Appendix 9) at Screening.
•6. Subjects with or without a history of plaque psoriasis can be enrolled (number of subjects enrolled with plaque psoriasis should not exceed 50%).
•7. Meet the following laboratory criteria at Screening:
•Hemoglobin = 90 g/L (= 9 g/dL).
•White blood cell count = 3.0 × 10^9/L (= 3.0 × 10^3/µL).
•Platelets = 100 × 10^9/L (= 100 × 10^3/µL).
•Serum creatinine <132.6 µmol/L (< 1.5 mg/dL).
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
•= 1.5 upper limit of normal (ULN),.
•Total bilirubin = 1.5 × ULN. Subjects with known Gilbert's disease who have serum bilirubin < 3 × ULN may be included.
•8. Body mass index (BMI) within the range of 18 to 36 kg/m2, inclusive {BMI = weight (kg)/[height (m)]2} and total body weight > 50 kg (110 lb).
•9. Subjects must be otherwise in a good health status as judged by the Investigator based on medical history, physical examination, ECG, hematology, chemistry,
•and urinalysis.
•10. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical
•Contraception and pregnancy:
•a) A male subject must agree to use contraception as detailed in Appendix 6 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 study treatment and refrain from donating sperm during this period.
•b) Female subjects:
•A female subject 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 Baseline (see Appendix 6), is not breastfeeding, and at least 1 of the following conditions apply:
•i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 6.
•ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 6 during the treatment period and for at least 6 months after
•receiving the study treatment and refrain 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 (eg, hormonal contraception should be initiated at least 48 days before
•11. Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in
•this protocol.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

排除标准

•1. Have other forms of psoriasis (eg, erythrodermic, guttate) except plaque psoriasis
•2. Have concomitant dermatological (eg, subcorneal pustular dermatosis, impetigo herpetiformis, acute generalized exanthematous
•pustulosis) or Medical conditions which may interfere with the Investigators' ability to evaluate the subject's response to therapy
•3. Have a history of clinically significant (as determined by the Investigator) cardiac, pulmonary, neurologic, gastrointestinal,
•endocrine, hematological, renal, hepatic, cerebral or psychiatric disease, or other major uncontrolled disease (a poorly controlled medical condition, such as but not limited to, poorly controlled diabetes, unstable ischemic heart disease, uncontrolled Hypertension (for definition of ranges see protocol) and moderate to severe heart failure [New York Heart Association Class III/IV])
•4. History of chronic or recurrent infectious disease, including but not limited to upper and lower respiratory infection (eg, sinusitis, bronchitis,
•and bronchiectasis), urinary tract infection (eg, recurrent pyelonephritis), and skin infection (eg, abscesses, infected skin wounds, or ulcers) within 24
•months prior to Screening. Subjects with a history of localized oral or genital herpes simplex that, in the opinion of the Investigator, is well controlled will be eligible for study participation
•5. History of a serious infection (eg, hepatitis, pneumonia) that led to hospitalization or treatment with IV antibiotics or antiviral treatment for an infection within 3 months prior to Screening or any recent infection requiring systemic antibiotic or systemic antiviral treatment within 4 weeks of Baseline
•6. History or any evidence of active infection within 4 weeks of Baseline (eg, bronchopulmonary, urinary, or gastrointestinal), excluding localized oral or genital herpes simplex that, in the opinion of the Investigator, is well-controlled
•7. Presence of any factors that would predispose the subject to develop infection (eg, rectal fissures, poor dentition)
•8. History of an opportunistic infection (eg, Pneumocystis carinii, aspergillosis, or mycobacteria other than tuberculosis [TB]), parasitic infections such as, but not exclusively, helminths, protozoa, Trypanosoma cruzi within 6 months prior to Screening
•9. History of a herpes zoster infection within 2 months prior to Screening
•10. Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, or other severe forms of atopy, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment
•11. Any history of known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status (eg, history of splenectomy)
•12. Any major surgery within 4 weeks of study treatment administration
•13. Malignancy or history of malignancy within 5 years prior to Screening, except for treated basal cell or squamous cell in situ carcinoma of the skin or squamous cell carcinomas deemed by the Principal Investigator to be fully treatable
•14. History of any significant drug allergy or reaction (such as anaphylaxis or hepatotoxicity) and reactivity to polysorbate 20, a component of ANB019 formulation, or the inactive ingredients

研究者

发起方

AnaptysBio Inc

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