A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Incyte Corporation0 个研究点目标入组 36 人开始时间: 2018年9月21日最近更新: 2019年12月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Incyte Corporation
入组人数: 36

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

入选标准

•1. Men and women aged 18 to 75 years at the time of consent.
•2. Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
•3. Stable course of HS for at least 90 days before screening, as determined by the investigator.
•4. HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II (ie, recurrent abscessed with tract formation and cicatrization; single or multiple, widely separated lesions) or Hurley Stage III (ie, diffuse or near diffuse involvement, or multiple interconnected tracts and abscesses across the entire area) at screening.
•5. Total AN count of at least 3 at screening and baseline.
•6. Willingness to avoid pregnancy or fathering children based on the criteria below:
•a. Male participants must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through 90 days after the last dose of study drug. Male participants must also refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participant and his understanding confirmed.
•b. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
•c. Women of nonchildbearing potential (ie, surgically sterile [hysterectomy, bilateral oophorectomy, or bilateral salpingectomy] OR postmenopausal, defined as = 12 months of amenorrhea before screening without an alternative medical cause, confirmed by FSH levels at screening) are eligible.
•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 27
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 9

排除标准

•1. Women who are currently pregnant or lactating.
•2. Presence of > 20 draining fistulas at screening and baseline.
•3. Participants with concurrent conditions or history of other diseases, as follows:
•a. Any clinically significant medical condition other than HS, as determined by the investigator, that is not adequately controlled with appropriate treatment.
•b. Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of HS.
•c. Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, make the participant an unsuitable candidate for the
•d. Current herpes zoster infection, a history of recurrent herpes zoster, a history of disseminated herpes simplex, or a history of herpes zoster.
•e. History of or ongoing serious illness or medical, physical or psychiatric condition(s) that – in the investigator's opinion – would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
•f. Albinism.
•4. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as = 450 msec.
•Note: Prolonged QTcF values of = 450 msec at screening are to be confirmed by performing 2 additional ECGs and averaging the results to determine whether the averaged value meets the exclusion criterion.
•5. Positive test result for TB from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening (or, if two indeterminate tests, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening).
•6. A history of active TB (treated or untreated) or a history of untreated latent TB. Note: If the participant has possible evidence of a latent TB infection, the participant must have documented completion of an adequate course of therapy for latent TB and provide recent (within 3 months) posteroanterior and lateral view chest X-rays without
•changes suggestive of active or latent TB, before baseline.
•7. Positive serology test results for HIV, HBsAg, HBV core antibody, or HCV
•(HCV-antibody with positive HCV-RNA) at screening.
•8. Decreased blood cell counts at screening, defined as follows:
•a. Leukocytes < 3.0 × 109/L (< 2.5 × 109/L for participants who are African-American).
•b. ANC < 1.5 × 109/L.
•c. Lymphocytes < 0.8 × 109/L.
•d. Hemoglobin < 10 g/dL.
•e. Platelets < 150 × 109/L.
•9. Severely impaired liver function (Child-Pugh Class C) or ALT or AST levels
•= 1.5 × ULN at screening.
•10. Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
•11. Use of the following medications:
•a. Previous use of JAK inhibitors, systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, and pacritinib).
•b. Previous use of adalimumab or any other TNF-a treatment within 12 weeks or 5 ha

研究者

发起方

Incyte Corporation

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