NCT04447729撤回2 期
A Multicenter, Open-label Pilot Study of the Efficacy and Safety of Fremanezumab for Treatment of Female Patients With Interstitial Cystitis-Bladder Pain Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- change from baseline in weekly average of the daily worst pain scores over the past 24 hours as measured on the PI-NRS
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of fremanezumab in reducing pain in patients with interstitial cystitis-bladder pain syndrome (IC-BPS).
A secondary efficacy objective of the study is to evaluate the effect of fremanezumab on other efficacy measures, including pain, voiding frequency, urinary symptoms, and quality of life.
And another secondary objective of the study is to evaluate the safety and tolerability of fremanezumab administered subcutaneously in adult patients with IC-BPS.
The planned active study period is 8 weeks; the entire planned study duration for each patient is 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •has a diagnosis of IC-BPS according to the American Urological Association endorsed criteria for a duration of ≥6 months to ≤15 years
- •has IC-BPS with moderate to severe bladder pain and urinary frequency
- •has urinary frequency of ≥8 voids/day
- •has had a cystoscopy within 6months before screening with report indicating absence of Hunner lesion(s). A patient who has not had a cystoscopy within 6months may undergo cystoscopy, at the physician's discretion, and be rescreened for study entry.
- •has persistent symptoms despite an adequate trial of 3 months of dietary counseling and modification
- •has a body mass index within 18.5 to 39 kg/m2 and a body weight ≥99 lbs.
- •has non-pharmacologic interventions (such as physical therapy, pelvic floor massage, acupuncture, naturopathy, new initiation of mindfulness exercises, or cognitive behavioral therapy) that are unchanged for a minimum of 30 days before the screening visit
- •if of childbearing potential, must meet any of the following criteria:
- •Patients must use 1 form of highly effective contraception with their partners during the entire study period and for 5 months after the last dose of the IMP
- •Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a study, and withdrawal are not acceptable methods of contraception.
- •Patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test at the screening visit (confirmed by urine dipstick β-HCG pregnancy test at baseline)
- •NOTE- Additional criteria apply; please contact the investigator for more information
排除标准
- •has any of the following confounding conditions: bladder stones, lower ureteric stones, vaginal candidiasis for which treatment was completed less than 30 days before the screening visit, urethral diverticulum, incomplete bladder emptying, overactive bladder (ie, urinary urgency associated with urinary incontinence or fear of incontinence), radiation cystitis, tuberculosis cystitis, vaginitis, neurogenic bladder, or any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the collection or interpretation of study results
- •is receiving any of the following treatments:
- •intravesical therapy of any kind, corticosteroid therapy, cyclosporine, or anti-tumor necrosis factor-α inhibitors within 2 months before the screening visit (visit 1)
- •cyclophosphamide or ketamine at any time
- •mAbs targeting the CGRP pathway (including erenumab, eptinezumab, galcanezumab, or fremanezumab) at any time; if the subject has participated in a clinical study with any of these mAbs, it has to be confirmed that the subject received placebo in order to be eligible for this study
- •has a known history of previous urinary diversion procedure with or without bladder removal or bladder augmentation
- •has a known history of a cystoscopy with bladder biopsy, hydrodistention, or fulguration or triamcinolone injection ≤3 months before the screening visit
- •was diagnosed with and/or treated for chronic migraine, defined as headaches occurring on ≥15 days/28-day period at any time over the past 3 months
- •is receiving prophylactic treatment for migraine disorders
- •has a known history of hypersensitivity reactions to injected proteins, including mAbs and animal venoms, or a history of Stevens-Johnson syndrome/toxic epidermal necrolysis syndrome
- •has a lifetime known history of any psychotic and/or bipolar disorder
- •NOTE- Additional criteria apply; please contact the investigator for more information
研究组 & 干预措施
fremanezumab
Experimental
Two doses, each dose consists of 4 injections with prefilled syringes
干预措施: fremanezumab (Drug)
结局指标
主要结局
change from baseline in weekly average of the daily worst pain scores over the past 24 hours as measured on the PI-NRS
时间窗: Baseline to weeks 4 and 8
Pain Intensity-Numerical Rating Scale (PI-NRS) - An 11-point scale that measures pain from 0 to 10 (0=no pain; 10=worst possible pain)
次要结局
- change from baseline in the weekly average of the daily average pain PI-NRS score(Baseline, Week 4, and 8)
- Change from baselines in frequency of voids over the past 24 hours and change in average void volume.(Baseline, Week 4, and 8)
- Patient's Global Impression of Change (PGIC)(Week 4 and 8)
- clinically significant changes in physical examination(Baseline - Week 8)
- anxiety and depression as measured by the HADS(Baseline - Week 8)
- change from baseline in the (GUPI) Questionnaire assessed over the most recent past 7 days(Baseline, Week 4, and 8)
- percent of patients who do not complete treatment due to all causes(8 weeks)
- Incidence of abnormal urinalysis laboratory test results.(Baseline - Week 8)
- Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings(Baseline - Week 8)
- local tolerability at the injection site(Week 1 and Week 4)
- percent of patients who do not complete the treatment due to adverse events(Baseline - Week 8)
- number of adverse events during the study(8 Weeks)
- Incidence of abnormal clinical laboratory test results (serum chemistry)(Baseline - Week 8)
- Incidence of abnormal hematology laboratory test results(Baseline - Week 8)
- change from baseline in the BPIC-SS assessed over the most recent past 7 days(Baseline, Week 4, and 8)
- Incidence of abnormal vital signs(Baseline - Week 8)
- number of hypersensitivity/anaphylaxis reactions(Baseline - Week 8)
- suicidal ideation and behavior as measured by the C-SSRS(Baseline - Week 8)
- Incidence of abnormal coagulation laboratory test results.(Baseline - Week 8)
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