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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Two doses, each dose consists of 4 injections with prefilled syringes
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)
Time frame: Baseline to weeks 4 and 8
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)
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)
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
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)
Time frame: 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).
Time frame: Baseline, Week 4, and 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
including body weight
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
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
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
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
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.
Time frame: Baseline - Week 8