A Phase II, Open Label Study of Bermekimab in Patients With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Phase 2 study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa.
详细描述
Phase 2, open label study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa. The study is multicenter and will consist of two patient groups, each of which will receive a total of 13 X 400mg weekly subcutaneous injections of bermekimab: Group A (n=10) patients who have failed anti-TNF therapy, and Group B (n=10) patients who have had no prior treatment with biological agents that block TNF.
Patients will be followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
Additionally, patients who had received the 200 mg weekly subcutaneous injections of bermekimab under the previous version of this protocol are eligible to begin receiving the 400 mg dose starting with his/her next scheduled visit, and for the remainder of his/her treatment plan.
XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent provided by the patient.
- •Male or female, age 18 years or greater.
- •For group A, patients must have received and failed anti-TNF therapy.
- •For Group B, patients must not have received any prior treatment with any anti-TNF therapy.
- •Patients who have received 200 mg dose of bermekimab in this study (previous version(s)) are eligible to begin receiving 400 mg dose starting with the patient's next scheduled visit for the remainder of his/her treatment plan.
- •Diagnosis of HS for at least 1 year prior to screening.
- •HS affecting at least two distinct anatomic areas, one of which is Hurley II or III stage.
- •A total body count of abscesses and inflammatory nodules (AN) of at least 3
- •Full understanding of the procedures of the study protocol and willingness to comply with them.
- •In case of female patients of childbearing potential, willingness to use one method of contraception of high efficacy during the entire study period. This method can be intake of hormonal contraceptives or the use of one of the following: condoms, diaphragm or an intrauterine device. Women of non-childbearing potential include those considered to have a medical history that indicates that pregnancy is not a reasonable risk, including post-menopausal women and those with a history of hysterectomy.
排除标准
- •Age below 18 years.
- •Receipt of oral antibiotic treatment for HS within 28 days prior to screening.
- •Receipt of prescription topical therapies for the treatment of HS within 14 days prior to screening, and/or systemic therapies for HS (immunosuppressants, corticosteroids, retinoids, or hormonal therapies) within 28 days prior to screening.
- •History of treatment with bermekimab for any reason, EXCEPT patients previously treated with 200 mg bermekimab dose in the previous version(s) of this study.
- •History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
- •Has received a live (attenuated) vaccine over the 4 weeks prior to screening.
- •New intake of opioid analgesics starting within 14 days prior to screening.
- •Major surgery (requiring general anesthesia or respiratory assistance) within 28 days prior to Visit 1, Day 0 of start of study drug.
- •Hepatic dysfunction defined as any value of transaminases or of γ-glutamyl transpeptidase (γGT), or of total bilirubin > 3 x upper normal limit
- •Stage C Child-Pugh liver cirrhosis.
- •Chronic infection by the human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV).
- •Neutropenia defined as <1,000 neutrophils/mm
- •Pregnancy or lactation.
研究组 & 干预措施
400mg cohort, no prior treatment with anti-TNF agent(s)
N=10 patients that have had no prior treatment with biological agents that block TNF will receive a total of 13 X 400mg subcutaneous injections of bermekimab. Dosing will occur weekly for 12 weeks, inclusive of visit 1 and visit 13.
干预措施: Bermekimab Monoclonal Antibody 400 mg (Drug)
400 mg cohort, prior treatment with anti-TNF agent(s)
N=10 patients that have failed anti-TNF therapy will receive a total of 13 X 400mg subcutaneous injections of bermekimab. Dosing will occur weekly for 12 weeks, inclusive of visit 1 and visit 13.
干预措施: Bermekimab Monoclonal Antibody 400 mg (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Up to Visit 14 (up to Day 93)
An adverse event is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical or biological agent under study.
次要结局
- Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease(Baseline and Week 12)
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12(Week 12)
- Plasma Concentration of Bermekimab(Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13))
- Change From Baseline to Week 12 in VAS Score for Pain(Baseline and Week 12)
- Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score(Baseline and Week 12)
- Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count(Baseline and Week 12)
- Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score(Baseline and Week 12)
- Change From Baseline to Week 12 in Modified Sartorius Score (mSS)(Baseline and Week 12)
- Change From Baseline to Week 12 in Hospital Anxiety Depression Scale (HADS)(Baseline and Week 12)
- Change From Baseline in Disease Activity Score (DAS) at Week 12(Baseline and Week 12)