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

NCT04447729 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: TV48125-CNS-20022
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Interstitial Cystitis

Keywords

Interstitial cystitis-bladder pain syndrome (IC-BPS)

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline to weeks 4 and 8

Secondary Outcomes (19)

• 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

• change from baseline in the BPIC-SS assessed over the most recent past 7 days

  Baseline, Week 4, and 8

• change from baseline in the (GUPI) Questionnaire assessed over the most recent past 7 days

  Baseline, Week 4, and 8

Study Arms (1)

fremanezumab

EXPERIMENTAL

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

Drug: fremanezumab

Interventions

fremanezumab DRUG

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

fremanezumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 25, 2020
• Study Start: October 15, 2020
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share