NCT03282318

Brief Summary

The purpose of this study is to investigate efficacy, safety and tolerability of ASP6294 in female participants with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). This study will also investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of ASP6294 in female participants with BPS/IC.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_2

Geographic Reach
10 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

September 12, 2017

Last Update Submit

October 29, 2024

Conditions

Bladder Pain SyndromeInterstitial Cystitis

Keywords

Bladder Pain SyndromeInterstitial CystitisASP6294

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Average Mean Daily Pain (MDP) Score at Week 12

    Participants will record their MDP each day in the evening into an e-diary. The MDP is the average pain experienced over the past 24 hours. The average MDP is the mean of daily assessments of MDP in the week prior to the visit with at least 5 recordings in that week. MDP is measured using an 11-point Numerical Rating Scale (NRS) ranging from 0 (no bladder pain) to 10 (worst imaginable bladder pain). A negative change indicates a reduction/improvement from baseline.

    Baseline and Week 12

Secondary Outcomes (6)

  • Change from Baseline in Average Worst Daily Pain (WDP) Score at Week 12

    Baseline and Week 12

  • Change From Baseline in Mean Voiding Frequency per 24 hours at Week 12

    Baseline and Week 12

  • Change From Baseline in Mean Number of Level 3 or 4 Urgency Episodes (Based on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24 hours at Week 12

    Baseline and Week 12

  • Change From Baseline in Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) Total Score at Week 12

    Baseline and Week 12

  • Change From Baseline in BPIC-SS Worst Bladder Pain (Question 8) Score at Week 12

    Baseline and Week 12

  • +1 more secondary outcomes

Study Arms (2)

ASP6294

EXPERIMENTAL

Participants will receive 320 mg ASP6294 subcutaneous injection at 4-week intervals at baseline (Day 1/Week 0), Week 4 and Week 8.

Drug: ASP6294

Placebo

PLACEBO COMPARATOR

Participants will receive placebo to match 320 mg ASP6294 subcutaneous injection at 4-week intervals at baseline (Day 1/Week 0), Week 4 and Week 8.

Drug: Placebo

Interventions

ASP6294DRUG

Participants will receive 320 mg ASP6294 subcutaneous injection at 4-week intervals at baseline (Day 1/Week 0), Week 4 and Week 8.

ASP6294
PlaceboDRUG

Participants will receive placebo to match 320 mg ASP6294 subcutaneous injection at 4-week intervals at baseline (Day 1/Week 0), Week 4 and Week 8.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject's signs, symptoms and diagnostic work-up are in accordance with the international society for the study of bladder pain syndrome (ESSIC) definition for bladder pain syndrome/interstitial cystitis (BPS/IC): pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least 1 other urinary symptom such as persistent urge to void or frequency, for at least 6 months in absence of urinary infection or other obvious pathology or identifiable causes. There is documented proof of the diagnosis BPS/IC that has been entered into the subject's records at least 2 months prior to Visit 1/Screening.
  • Subject has a score of ≥ 4 and ≤ 9 for pain as assessed by scoring the average pain of the week preceding Visit 1/Screening, using an 11-point NRS (0-10).
  • Subject has an estimated voiding frequency of ≥ 8 and ≤ 30 voids per 24 hours.
  • Subject has a score of ≥ 7 on the interstitial cystitis symptom index (ICSI) questionnaire.
  • Subject must either:
  • Be of nonchildbearing potential:
  • Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or
  • Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
  • Or, if of childbearing potential,
  • Agree not to try to become pregnant during the study and for 5 half-lives (i.e., 70 days) after the final study drug administration at Visit 5/Week 8, and
  • Have a negative urine pregnancy test at Visit 1/Screening, and
  • If heterosexually active, agree to consistently use 1 form of highly effective birth control starting at screening and throughout the study period and for 5 half-lives (i.e., 70 days) after the final study drug administration at Visit 5/Week 8.
  • Subject must agree not to breastfeed starting at screening and throughout the study period, and for 5 half-lives (i.e., 70 days) after the final study drug administration at Visit 5/Week 8.
  • Subject must agree not to donate ova starting at screening and throughout the study period, and for 5 half-lives (i.e., 70 days) after the final study drug administration at Visit 5/Week 8.
  • Subject must be willing and able to comply with study requirements (e.g., complete questionnaires and diaries, able to read and attend all required study visits).
  • +5 more criteria

You may not qualify if:

  • Subject has osteoarthritis or has a history of rapidly progressive osteoarthritis.
  • Subject has a score of ≥ 30 on the Pain Catastrophizing Scale (PCS).
  • Subject has a score of \> 12 on the HADS-D (Hospital Anxiety and Depression Scale - Depression subscale).
  • Subject has significant pelvic floor pain or spasm which is considered the main cause of the chronic pelvic/bladder pain as concluded by the investigator based on the pelvic floor examination.
  • Subject has undergone a fulguration or excision of a Hunner's lesion any time prior to the screening visit.
  • Subject has recently undergone or started treatment for BPS/IC as specified below:
  • subject has undergone a cystoscopy with hydrodistension or Botox injections in the bladder within 6 months prior to the screening visit.
  • subject has received non-pharmacological interventions for BPS/IC (including but not limited to electric stimulation therapy or acupuncture therapy) within 3 months prior to the screening visit.
  • subject has received any intravesical pharmacological treatment for BPS/IC (including but not limited to heparin or dimethyl sulfoxide) within 4 weeks prior to the screening visit
  • subject had an initiation, discontinuation, or variation in the dose and/or frequency of antimuscarinics, mirabegron, antidepressants (including amitriptyline), anticonvulsants, benzodiazepines, skeletal muscle relaxants, nonsteroidal anti-inflammatory drugs, non-opioid analgesics, pentosan polysulphate sodium, homeopathic medication and/or herbal therapies during the last 4 weeks prior to the screening visit.
  • subject has had changes in non-pharmacological treatment for BPS/IC (e.g., diet or physical therapy) during the last 4 weeks prior to the screening visit.
  • Subject has bladder pathology as specified below:
  • a post-void residual (PVR) \>200 mL.
  • subject has a known currently symptomatic urethral diverticulum.
  • subject has a known currently symptomatic bladder or ureteral calculi.
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Site BE32001

Leuven, Belgium

Location

Site CZ42002

Pilsen, Czechia

Location

Site DE49003

Duisburg, Germany

Location

Site DE49007

Duisburg, Germany

Location

Site DE49001

Holzminden, Germany

Location

Site DE49005

Markkleeberg, Germany

Location

Site HU36002

Budapest, Hungary

Location

Site HU36001

Csongrád, Hungary

Location

Site LV37103

Daugavpils, Latvia

Location

Site LV37101

Riga, Latvia

Location

Site LV37102

Riga, Latvia

Location

Site LV37105

Riga, Latvia

Location

Site NL31007

Sneek, Netherlands

Location

Site PL48009

Lodz, Poland

Location

Site PL48002

Szczecin, Poland

Location

Site PL48010

Warsaw, Poland

Location

Site PL48007

Wroclaw, Poland

Location

Site RU70001

Saint Petersburg, Russia

Location

Site RU70002

Saint Petersburg, Russia

Location

Site RU70003

Saint Petersburg, Russia

Location

Site RU70006

Saint Petersburg, Russia

Location

Site RU70008

Saint Petersburg, Russia

Location

Site ES34001

Barcelona, Spain

Location

Site ES34008

Madrid, Spain

Location

Site ES34002

Málaga, Spain

Location

Site ES34007

Valencia, Spain

Location

Site GB44002

Manchester, United Kingdom

Location

Site GB44006

Plymouth, United Kingdom

Location

Related Publications (1)

  • Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

    PMID: 32734597DERIVED

Related Links

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Project Physician

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 13, 2017

Study Start

September 28, 2017

Primary Completion

March 21, 2019

Study Completion

March 21, 2019

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
More information

Locations

DE(4)CZ(1)NL(1)RU(5)PL(4)LA(4)ES(4)GB(2)HU(2)BE(1)