NL-OMON46316已完成2 期
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa - NOVA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
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
- •-Be a man or a woman at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
- •-Have moderate to severe HS for at least 1 year (365 days) prior to the baseline visit.
- •-Have HS lesions present in at least 2 distinct anatomic areas.
- •-Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS.
- •-Have stable HS for at least 1 month (28 days) prior to the screening visit.
- •-Have a total abscess and inflammatory nodule (AN) count of *3 at the screening and baseline visit.
- •-Must agree to daily use of one of the following over-the-counter treatments to the body areas affected with HS lesions: either soap and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan, or benzoyl peroxide, or a dilute bleach bath.
- •-Before randomization, a woman must be either:
- •a. not of childbearing potential;
- •b. of childbearing potential and practicing a highly effective method of birth control.
- •-A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 prior to administration of study intervention.
- •-A woman must agree not to donate eggs for the purposes of assisted reproduction during the study and for at least 12 weeks after receiving the last administration of study intervention.
- •-A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control.
- •-Are considered eligible according to the following TB screening criteria:
- •a. have no history of latent or active TB before screening;
- •b. have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
- •c. have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before the first administration of study intervention;
- •d. within 2 months before the first administration of study intervention, have a negative QuantiFERON®-TB Gold test result, or have a newly identified positive QuantiFERON®-TB test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study intervention;
- •e. have a chest radiograph (both posterior-anterior and lateral views, or per country regulations where applicable), taken within 3 months before the first administration of study intervention and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
- •-Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
- •-Agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study intervention.
- •-Have screening laboratory test results within the following parameters:
- •a. Hemoglobin *10 g/dL
- •b. White blood cells *3.5 x 103/µL
- •c. Neutrophils *1.5 x 103/µL
- •d. Platelets *100 x 103/µL
- •e. Serum creatinine *1.5 mg/dL
- •f. Aspartate aminotransferase *2 × upper limit of normal (ULN)
- •g. Alanine aminotransferase *2 × ULN
- •h. Alkaline phosphatase *2 × ULN
- •-Be willing and able to adhere to the prohibitions and restrictions
排除标准
- •-Has previously received guselkumab.
- •-Any other active skin disease or condition that could have interfered with assessment of HS.
- •-Has a draining fistula count of >20 at the baseline visit.
- •-Receipt of immunomodulatory biologic therapies (eg monoclonal antibodies) within 3 months or 5 half-lives prior to the baseline visit, whichever is longer.
- •-Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 weeks prior to the baseline visit.
- •-Receipt of systemic non-biologic therapies for the treatment of HS <4 weeks prior to the baseline visit.
- •-Has received any therapeutic agent directly targeted to IL-17 or IL-23 within 6 months of the first administration of study intervention (including but not limited to ustekinumab, tildrakizumab, risankizumab, secukinumab, ixekizumab, or brodalumab).
- •-Has received natalizumab, belimumab, or agents that modulate B cells or T cells (eg, rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study intervention.
- •-Has received any systemic immunosuppressants (eg, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus) or anakinra within 4 weeks of the first administration of study intervention.
- •-Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
- •-Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months.
- •-Currently has a malignancy or has a history of malignancy within 5 years before screening.
- •-Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received IV antibiotics for an infection during the 2 months before screening.;For a complete list of all exclusion criteria, please refer to section 5.2 of the protocol on page 26-30.
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