NCT03248531已完成2 期
A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 31
- 主要终点
- Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
研究概览
简要总结
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least
- •1 year prior to Baseline
- •Stable HS for at least 2 months prior to Screening and also at the Baseline Visit
- •Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS
- •Total abscess and inflammatory nodule count >=3 at the Baseline Visit
- •Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified over-the-counter topical antiseptics on their HS lesions
- •Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
- •Male subjects must be willing to use a method of contraception when sexually active, up till 20 weeks after the last administration of study medication
排除标准
- •Prior treatment with anti-IL17s or participation in an anti-IL17 study
- •Previously received anti-TNFs
- •Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol)
- •Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline Visit
- •Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline Visit
- •Draining fistula count >20 at the Baseline Visit
- •Diagnosis of inflammatory conditions other than HS
研究组 & 干预措施
Bimekizumab
Experimental
Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
干预措施: Bimekizumab (Drug)
Adalimumab
Active Comparator
Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
干预措施: Adalimumab (Drug)
Placebo
Placebo Comparator
Subjects will receive several placebo applications to keep the blinding.
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
时间窗: Week 12
HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.
次要结局
- Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)(Day 1 (Prior to first dose))
- Bimekizumab Plasma Concentration at Week 2(Week 2)
- Bimekizumab Plasma Concentration at Week 4(Week 4)
- Bimekizumab Plasma Concentration at Week 8(Week 8)
- Bimekizumab Plasma Concentration at Week 12(Week 12)
- Bimekizumab Plasma Concentration at Week 30(Week 30)
- Percentage of Participants With at Least One Adverse Event During the Study(From Screening to Safety Follow-Up (Week 30))
- Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study(From Screening to Safety Follow-Up (Week 30))
- Percentage of Participants With at Least One Serious Adverse Event During the Study(From Screening to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)(From Baseline to Safety Follow-Up (Week 30))
- Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study(From Screening to Safety Follow-Up (Week 30))
- Percentage of Participants That Withdrew Due to Adverse Events During the Study(From Screening to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Body Weight(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)(From Baseline to Safety Follow-Up (Week 30))
- Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)(From Baseline to Safety Follow-Up (Week 30))
- Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)(From Baseline to Safety Follow-Up (Week 30))
- Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)(From Baseline to Safety Follow-Up (Week 30))
- Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)(From Baseline to Safety Follow-Up (Week 30))
- Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)(From Baseline to Safety Follow-Up (Week 30))
- Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination(From Baseline to Safety Follow-Up (Week 30))
- Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1(Day 1)
- Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2(Week 2)
- Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4(Week 4)
- Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8(Week 8)
- Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12(Week 12)
- Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30(Week 30)
研究者
研究点 (31)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic TherapyHidradenitis SuppurativaNCT05139602AbbVie210
进行中（未招募）
3 期
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT06468228AbbVie1,400
招募中
不适用
Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen RepositoryHidradenitis SuppurativaNCT04115566University of California, San Francisco3,000
已完成
2 期
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease SymptomsHidradenitis Suppurativa (HS)NCT04430855AbbVie68
终止
不适用
Safety and Treatment of Cryoinsufflation in Treatment of Hidradenitis SuppurativaHidradenitis SuppurativaNCT05830149Henry Ford Health System1