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A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome

Primary Purpose

Interstitial Cystitis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fremanezumab
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis-bladder pain syndrome (IC-BPS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    fremanezumab

    Arm Description

    Two doses, each dose consists of 4 injections with prefilled syringes

    Outcomes

    Primary Outcome Measures

    change from baseline in weekly average of the daily worst pain scores over the past 24 hours as measured on the PI-NRS
    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)

    Secondary Outcome Measures

    change from baseline in the weekly average of the daily average pain PI-NRS score
    The Pain Intensity-Numerical Rating Scale (PI-NRS) is an 11-point scale that measures pain from 0 to 10 (0=no pain; 10=worst possible pain)
    Change from baselines in frequency of voids over the past 24 hours and change in average void volume.
    Patient's Global Impression of Change (PGIC)
    Improvement is recorded on a 7-point scale, with 1 indicating very much improved, 4 indicating no change, and 7 indicating very much worse
    change from baseline in the BPIC-SS assessed over the most recent past 7 days
    Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) an 8-item questionnaire. Scores may range from 0 to 38 (0=no symptoms, 38=most severe symptoms)
    change from baseline in the (GUPI) Questionnaire assessed over the most recent past 7 days
    Genitourinary Pain Index (GUPI) Questionnaire. The GUPI has 10 pain items (total pain subscale score 0 to 23), 2 urinary symptom items (total urinary subscale score 0 to 10), and 3 QOL items (total QOL subscale score: 0 to 12).
    percent of patients who do not complete treatment due to all causes
    number of adverse events during the study
    Incidence of abnormal clinical laboratory test results (serum chemistry)
    Incidence of abnormal hematology laboratory test results
    Incidence of abnormal coagulation laboratory test results.
    Incidence of abnormal urinalysis laboratory test results.
    Incidence of abnormal vital signs
    clinically significant changes in physical examination
    including body weight
    Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
    local tolerability at the injection site
    Injection sites will be assessed for erythema, induration, ecchymosis, and pain immediately (ie, within 20 minutes ±5 minutes) and 1 hour (±15 minutes) after IMP administration.
    number of hypersensitivity/anaphylaxis reactions
    percent of patients who do not complete the treatment due to adverse events
    anxiety and depression as measured by the HADS
    Hospital Anxiety and Depression Scale (HADS): Scale for both anxiety and depression scored separately: 8-10 Mild, 11-14 Moderate, 15-21 Severe
    suicidal ideation and behavior as measured by the C-SSRS
    The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Questions included the presence of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide. The most severe type of ideation (i.e., 1-5 with 1 being the least severe and 5 being the most severe.

    Full Information

    First Posted
    June 10, 2020
    Last Updated
    November 5, 2021
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04447729
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn due to logistic reasons
    Study Start Date
    October 15, 2020 (Anticipated)
    Primary Completion Date
    February 10, 2022 (Anticipated)
    Study Completion Date
    February 10, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Interstitial Cystitis
    Keywords
    Interstitial cystitis-bladder pain syndrome (IC-BPS)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    fremanezumab
    Arm Type
    Experimental
    Arm Description
    Two doses, each dose consists of 4 injections with prefilled syringes
    Intervention Type
    Drug
    Intervention Name(s)
    fremanezumab
    Intervention Description
    Two doses, each dose consists of 4 injections with prefilled syringes
    Primary Outcome Measure Information:
    Title
    change from baseline in weekly average of the daily worst pain scores over the past 24 hours as measured on the PI-NRS
    Description
    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)
    Time Frame
    Baseline to weeks 4 and 8
    Secondary Outcome Measure Information:
    Title
    change from baseline in the weekly average of the daily average pain PI-NRS score
    Description
    The Pain Intensity-Numerical Rating Scale (PI-NRS) is an 11-point scale that measures pain from 0 to 10 (0=no pain; 10=worst possible pain)
    Time Frame
    Baseline, Week 4, and 8
    Title
    Change from baselines in frequency of voids over the past 24 hours and change in average void volume.
    Time Frame
    Baseline, Week 4, and 8
    Title
    Patient's Global Impression of Change (PGIC)
    Description
    Improvement is recorded on a 7-point scale, with 1 indicating very much improved, 4 indicating no change, and 7 indicating very much worse
    Time Frame
    Week 4 and 8
    Title
    change from baseline in the BPIC-SS assessed over the most recent past 7 days
    Description
    Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) an 8-item questionnaire. Scores may range from 0 to 38 (0=no symptoms, 38=most severe symptoms)
    Time Frame
    Baseline, Week 4, and 8
    Title
    change from baseline in the (GUPI) Questionnaire assessed over the most recent past 7 days
    Description
    Genitourinary Pain Index (GUPI) Questionnaire. The GUPI has 10 pain items (total pain subscale score 0 to 23), 2 urinary symptom items (total urinary subscale score 0 to 10), and 3 QOL items (total QOL subscale score: 0 to 12).
    Time Frame
    Baseline, Week 4, and 8
    Title
    percent of patients who do not complete treatment due to all causes
    Time Frame
    8 weeks
    Title
    number of adverse events during the study
    Time Frame
    8 Weeks
    Title
    Incidence of abnormal clinical laboratory test results (serum chemistry)
    Time Frame
    Baseline - Week 8
    Title
    Incidence of abnormal hematology laboratory test results
    Time Frame
    Baseline - Week 8
    Title
    Incidence of abnormal coagulation laboratory test results.
    Time Frame
    Baseline - Week 8
    Title
    Incidence of abnormal urinalysis laboratory test results.
    Time Frame
    Baseline - Week 8
    Title
    Incidence of abnormal vital signs
    Time Frame
    Baseline - Week 8
    Title
    clinically significant changes in physical examination
    Description
    including body weight
    Time Frame
    Baseline - Week 8
    Title
    Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
    Time Frame
    Baseline - Week 8
    Title
    local tolerability at the injection site
    Description
    Injection sites will be assessed for erythema, induration, ecchymosis, and pain immediately (ie, within 20 minutes ±5 minutes) and 1 hour (±15 minutes) after IMP administration.
    Time Frame
    Week 1 and Week 4
    Title
    number of hypersensitivity/anaphylaxis reactions
    Time Frame
    Baseline - Week 8
    Title
    percent of patients who do not complete the treatment due to adverse events
    Time Frame
    Baseline - Week 8
    Title
    anxiety and depression as measured by the HADS
    Description
    Hospital Anxiety and Depression Scale (HADS): Scale for both anxiety and depression scored separately: 8-10 Mild, 11-14 Moderate, 15-21 Severe
    Time Frame
    Baseline - Week 8
    Title
    suicidal ideation and behavior as measured by the C-SSRS
    Description
    The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Questions included the presence of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide. The most severe type of ideation (i.e., 1-5 with 1 being the least severe and 5 being the most severe.
    Time Frame
    Baseline - Week 8

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Teva Medical Expert, MD
    Organizational Affiliation
    Teva Branded Pharmaceutical Products R&D, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

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    A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome

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