Interstitial CystitisPhase 2NCT04447729
A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome
A Phase 2 study testing fremanezumab in people with Interstitial Cystitis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- fremanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to 10 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
About this study
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
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
- Being tested
- fremanezumab
- Keywords
- Interstitial cystitis-bladder pain syndrome (IC-BPS)
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fremanezumabDrug
Two doses, each dose consists of 4 injections with prefilled syringes
| Study group | Role | What they receive |
|---|---|---|
| fremanezumab | Experimental | Two doses, each dose consists of 4 injections with prefilled syringes Receives: Drug: fremanezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to weeks 4 and 8
Secondary outcomes (19)
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)
Measured: Baseline, Week 4, and 8
Change from baselines in frequency of voids over the past 24 hours and change in average void volume.
Measured: Baseline, Week 4, and 8
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
Measured: Week 4 and 8
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)
Measured: Baseline, Week 4, and 8
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).
Measured: Baseline, Week 4, and 8
percent of patients who do not complete treatment due to all causes
Measured: 8 weeks
number of adverse events during the study
Measured: 8 Weeks
Incidence of abnormal clinical laboratory test results (serum chemistry)
Measured: Baseline - Week 8
Incidence of abnormal hematology laboratory test results
Measured: Baseline - Week 8
Incidence of abnormal coagulation laboratory test results.
Measured: Baseline - Week 8
Incidence of abnormal urinalysis laboratory test results.
Measured: Baseline - Week 8
Incidence of abnormal vital signs
Measured: Baseline - Week 8
clinically significant changes in physical examination
including body weight
Measured: Baseline - Week 8
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
Measured: Baseline - Week 8
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.
Measured: Week 1 and Week 4
number of hypersensitivity/anaphylaxis reactions
Measured: Baseline - Week 8
percent of patients who do not complete the treatment due to adverse events
Measured: Baseline - Week 8
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
Measured: Baseline - Week 8
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.
Measured: Baseline - Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start15 Oct 2020 (estimated)
- Primary completion10 Feb 2022 (estimated)
- Study completion10 Feb 2022 (estimated)
Why it stopped: Withdrawn due to logistic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447729
- Sponsor's protocol ID
- TV48125-CNS-20022
- Status last verified
- Nov 2021
- First submitted
- 10 Jun 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04447729
- Acronym / sponsor ID
- TV48125-CNS-20022
- Conditions
- Interstitial Cystitis
- Keywords
- Interstitial cystitis-bladder pain syndrome (IC-BPS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to logistic reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 10 Feb 2022 (estimated)
- Study completion
- 10 Feb 2022 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fremanezumab | Experimental | Drug: fremanezumabTwo doses, each dose consists of 4 injections with prefilled syringes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fremanezumabTwo doses, each dose consists of 4 injections with prefilled syringes | Drug | fremanezumab |
Primary outcome
change from baseline in weekly average of the daily worst pain scores over the past 24 hours as measured on the PI-NRS
Time frame: 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)
19 secondary outcomes
change from baseline in the weekly average of the daily average pain PI-NRS score
Time frame: Baseline, Week 4, and 8
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
Patient's Global Impression of Change (PGIC)
Time frame: Week 4 and 8
change from baseline in the BPIC-SS assessed over the most recent past 7 days
Time frame: Baseline, Week 4, and 8
change from baseline in the (GUPI) Questionnaire assessed over the most recent past 7 days
Time frame: Baseline, Week 4, and 8
percent of patients who do not complete treatment due to all causes
Time frame: 8 weeks
number of adverse events during the study
Time frame: 8 Weeks
Incidence of abnormal clinical laboratory test results (serum chemistry)
Time frame: Baseline - Week 8
Incidence of abnormal hematology laboratory test results
Time frame: Baseline - Week 8
Incidence of abnormal coagulation laboratory test results.
Time frame: Baseline - Week 8
Incidence of abnormal urinalysis laboratory test results.
Time frame: Baseline - Week 8
Incidence of abnormal vital signs
Time frame: Baseline - Week 8
clinically significant changes in physical examination
Time frame: Baseline - Week 8
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
Time frame: Baseline - Week 8
local tolerability at the injection site
Time frame: Week 1 and Week 4
number of hypersensitivity/anaphylaxis reactions
Time frame: Baseline - Week 8
percent of patients who do not complete the treatment due to adverse events
Time frame: Baseline - Week 8
anxiety and depression as measured by the HADS
Time frame: Baseline - Week 8
suicidal ideation and behavior as measured by the C-SSRS
Time frame: Baseline - Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fremanezumab in people with Interstitial Cystitis, run by Teva Branded Pharmaceutical Products R&D, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in weekly average of the daily worst pain scores over the past 24 hours as measured on the PI-NRS (time frame: Baseline to weeks 4 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.