A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis (SERENITY)
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|ClinicalTrials.gov Identifier: NCT03282318|
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bladder Pain Syndrome Interstitial Cystitis||Drug: ASP6294 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||163 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis|
|Actual Study Start Date :||September 28, 2017|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Participants will receive subcutaneous (SC) administrations of ASP6294 at weeks 0, 4 and 8.
Subcutaneous (SC) injection
Placebo Comparator: Placebo
Participants will receive SC administrations of Placebo at weeks 0, 4 and 8.
- Change from baseline in average mean daily pain (MDP) at Visit 6/Week 12 [ Time Frame: Baseline and Week 12 ]Participants will record participant's MDP each day in the evening into an e-diary. The MDP is the average pain experienced over the past 24 hours. MDP is measured using the 11-point numerical rating scale (NRS), (0-10) with 0 being no bladder pain and 10 being the worst possible pain.
- Change from baseline in average worst daily pain (WDP) at Visit 6/Week 12 [ Time Frame: Baseline and Week 12 ]Participants will record participant's WDP each day in the evening into an e-diary. The WDP is the worst pain experienced over the past 24 hours. WDP is measured using the 11-point numerical rating scale (NRS), (0-10) with 0 being no bladder pain and 10 being the worst possible pain.
- Change from baseline in mean voiding frequency at Visit 6/Week 12 [ Time Frame: Baseline and Week 12 ]The mean voiding frequency is the mean of the recordings of voiding frequency in the 3 day electronic micturition diary in the week prior to the visit, with at least 2 days recorded in that week.
- Change from baseline in mean number of level 3 or 4 urgency episodes (using the PPIUS) per 24 hours as assessed with the 3 day electronic micturition diary within the week preceding the study visit, at Visit 6/Week 12 [ Time Frame: Baseline and Week 12 ]The patient perception of intensity of urgency scale (PPIUS) is a 5-point categorical scale and has a range from 0-4. 0 meaning "No urgency, I felt no need to empty my bladder, but did so for other reasons." and 4 meaning "Urge incontinence, I leaked before arriving to the toilet."
- Assessment of the Global Response Assessment (GRA) at Visit 6/Week 12 [ Time Frame: Up to Week 12 ]The GRA is self-reported and is a 7 grade GRA used to evaluate a participant's clinical condition relative to Baseline. The GRA reads: As compared to when the participant started the study, how would the participant rate the participant's overall symptoms now? The 7 GRA grades are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly improved", "moderately improved" or "markedly improved". A successful GRA response is defined as the scores "moderately improved" or "markedly improved" disease.
- Change from baseline in Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) at Visit 6/Week 12 [ Time Frame: Baseline and Week 12 ]The BPIC-SS is a psychometrically validated and reliable questionnaire with 8 questions concerning bladder pain over the previous 7 days. The BPIC-SS addresses urinary symptoms in 5 questions, all rated 0 - 4 (how often urinated because of pain, need to urinate just after previous urination, urination to avoid pain, pressure in the bladder and pain in the bladder), 2 questions address the impact of bladder pain (bothered by frequent urination during daytime and nighttime) and ends with a 0 - 10 NRS on worst pain over the last 7 days with 0 being no bladder pain and 10 being the worst possible pain. The total score will range from 0 to 38 with higher scores representing a worse situation, with a score of 19 or more indicating moderate/severe disease activity. Question 8 from the BPIC-SS is the question on worst bladder pain over the last 7 days on a 0-10 point NRS.
- Safety assessed by frequency, nature and severity of Adverse Events (AEs) [ Time Frame: Up to Week 18 ]An AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
- Number of participants with laboratory value abnormalities and/or AEs [ Time Frame: Up to Week 18 ]Number of participants with potentially clinically significant laboratory values.
- Number of participants with vital signs abnormalities and/or AEs [ Time Frame: Up to Week 18 ]Number of participants with potentially clinically significant vital sign values.
- Safety assessed by 12- lead electrocardiogram (ECG) [ Time Frame: Up to Week 18 ]ECGs will be recorded with the participant in the supine position, after the participant has been lying down for approximately 5 minutes. There should be at least 5 minutes between ECG measurements in case a repeat is needed. Any clinically significant adverse changes on the ECG will be reported as an AE.
- Safety assessed by sensory testing [ Time Frame: Up to Week 18 ]The sensory status will be assessed bilaterally on the participant's first toe, using 3 tests: the vibration test, the light touch test and the pin prick test.
- Number of participants with Physical Exam abnormalities and/or AEs/Serious Adverse Events (SAEs) [ Time Frame: Up to Week 18 ]Number of participants with potentially clinically significant physical exam values.
- Pharmacokinetics assessed by serum level of ASP6294 [ Time Frame: Up to Week 18 ]ASP6294 serum levels will be evaluated in blood samples collected.
- Pharmacodynamics assessed by serum level of total nerve growth factor (NGF) [ Time Frame: Up to Week 18 ]Total NGF serum levels will be evaluated in blood samples collected.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282318
|Contact: Clinical Science||+31 (0) 71 5455 firstname.lastname@example.org|
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|Study Director:||Project Physician||Astellas Pharma Europe B.V.|