Clinical trial NCT04447729: A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome
Official title: A Multicenter, Open-label Pilot Study of the Efficacy and Safety of Fremanezumab for Treatment of Female Patients With Interstitial Cystitis-Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Interstitial Cystitis
Keywords: Interstitial cystitis-bladder pain syndrome (IC-BPS)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: change from baseline in weekly average of the daily worst pain scores over the past 24 hours as measured on the PI-NRS
timeFrame: Baseline to weeks 4 and 8
Secondary outcomes:
measure: change from baseline in the weekly average of the daily average pain PI-NRS score
timeFrame: Baseline, Week 4, and 8
measure: Change from baselines in frequency of voids over the past 24 hours and change in average void volume.
timeFrame: Baseline, Week 4, and 8
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Week 4 and 8
measure: change from baseline in the BPIC-SS assessed over the most recent past 7 days
timeFrame: Baseline, Week 4, and 8
measure: change from baseline in the (GUPI) Questionnaire assessed over the most recent past 7 days
timeFrame: Baseline, Week 4, and 8
measure: percent of patients who do not complete treatment due to all causes
timeFrame: 8 weeks
measure: number of adverse events during the study
timeFrame: 8 Weeks
measure: Incidence of abnormal clinical laboratory test results (serum chemistry)
timeFrame: Baseline - Week 8
measure: Incidence of abnormal hematology laboratory test results
timeFrame: Baseline - Week 8
measure: Incidence of abnormal coagulation laboratory test results.
timeFrame: Baseline - Week 8
measure: Incidence of abnormal urinalysis laboratory test results.
timeFrame: Baseline - Week 8
measure: Incidence of abnormal vital signs
timeFrame: Baseline - Week 8
measure: clinically significant changes in physical examination
timeFrame: Baseline - Week 8
measure: Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
timeFrame: Baseline - Week 8
measure: local tolerability at the injection site
timeFrame: Week 1 and Week 4
measure: number of hypersensitivity/anaphylaxis reactions
timeFrame: Baseline - Week 8
measure: percent of patients who do not complete the treatment due to adverse events
timeFrame: Baseline - Week 8
measure: anxiety and depression as measured by the HADS
timeFrame: Baseline - Week 8
measure: suicidal ideation and behavior as measured by the C-SSRS
timeFrame: Baseline - Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: