Clinical Trials Register

Summary
EudraCT Number:	2019-002575-34
Sponsor's Protocol Code Number:	19733
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-02-25
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2019-002575-34

A.3

Full title of the trial

A randomized, placebo-controlled, double-blind, parallel-group, multi-center, proof-of concept study to assess the efficacy and safety of BAY 1817080 in patients with overactive bladder (OAB) over a 12-week treatment period.

Randomizovaná, placebem kontrolovaná, dvojitě zaslepená, paralelní, multicentrická studie k ověření konceptu s cílem zhodnotit účinnost
a bezpečnost BAY 1817080 u pacientů s hyperaktivním močovým měchýřem (OAB) v průběhu 12týdenního léčebného období

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical study to evaluate the treatment effect and safety of BAY1817080 in patients with overactive bladder (OAB)

Klinická studie hodnotící léčebný účinek a bezpečnost BAY 1817080 u pacientů s hyperaktivním močovým měchýřem (OAB).

A.3.2

Name or abbreviated title of the trial where available

Ovader

A.4.1

Sponsor's protocol code number

19733

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bayer AG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bayer AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer AG
B.5.2	Functional name of contact point	Clinical Trial Contacts
B.5.3	Address:
B.5.3.1	Street Address	CTP Team/ Ref. EU CTR Bayer Pharma AG
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.6	E-mail	clinical-trials-contact@bayer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BAY 1817080 25 mg tablets
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Eliapixant
D.3.9.1	CAS number	n/A
D.3.9.2	Current sponsor code	BAY 1817080
D.3.9.3	Other descriptive name	BAY 1817080
D.3.9.4	EV Substance Code	SUB181864
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BAY 1817080 100 mg tablets
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Eliapixant
D.3.9.1	CAS number	n/A
D.3.9.2	Current sponsor code	BAY 1817080
D.3.9.3	Other descriptive name	BAY 1817080
D.3.9.4	EV Substance Code	SUB181864
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Overactive bladder

E.1.1.1

Medical condition in easily understood language

A condition that causes sudden, uncontrolled need or urge to urinate and in some cases may lead to urinary leakage

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10059617
E.1.2	Term	Overactive bladder
E.1.2	System Organ Class	100000004857

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of BAY1817080 125 mg twice a day (BID) in comparison to placebo in the treatment of OAB with urgency urinary incontinence (UUI) over a 12-week treatment period

E.2.2

Secondary objectives of the trial

To further evaluate the efficacy of BAY1817080 125 mg BID in comparison to placebo in the treatment of OAB with urgency urinary incontinence (UUI) over a 12-week treatment period

To evaluate the safety and tolerability of BAY1817080 125 mg BID in comparison to placebo over a treatment period of up to 12-weeks

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria at screening：
1. Adults ≥ 18 years of age at the time of signing the informed consent
2. Have “wet” OAB symptoms (urgency, frequency and urinary incontinence) for ≥ 3 months prior to screening visit
3. Women of childbearing potential (WOCBP) must agree to use acceptable effective or highly effective contraceptive methods
4. Capable of giving signed informed consent
5. Willing and able to complete the electronic bladder diary and questionnaires

Inclusion criteria at baseline (to be checked at V3, prior to randomization):
6. Completion of all 3 days of 3-day electronic bladder diary during run-in phase
7. Compliance of ≥80% with intake of study intervention during run-in
8. Frequency of micturition on average ≥ 8 episodes/24 hours during the run-in phase according to 3-day electronic bladder diary
9. Frequency of urgency urinary incontinence on average ≥ 1 episode/24 hours during the run-in phase according to 3-day electronic bladder diary

E.4

Principal exclusion criteria

1. Polyuria known or based on the clinical evidence during the run-in phase recorded in the 3-day electronic bladder diary and the investigator´s clinical judgement
2. Significant stress incontinence or mixed stress/urgency incontinence
3. Post-void residual volume (PVR) > 150 mL at Visit 1 or at Visit 3
4. In need of catheterization (indwelling or intermittent)
5. Clinically significant urinary outflow obstruction
6. Previous pelvic radiation, or previous or current malignant disease of pelvic organs
7. Neurogenic bladder
8. Bladder pain syndrome/interstitial cystitis
9. Recurrent and/or symptomatic bladder stones
10. Current symptomatic or recent (within 30 days prior to Visit 1), or recurrent (2 or more infections within 6 months, or > 3 infections within 12 months) urinary tract infection
11. Unexplained macro- or micro-hematuria
12. Diabetes insipidus
13. Diabetes mellitus with inadequate glycemic control as indicated by HbA1C result of > 8% at screening
14. Clinically significant cardiovascular or cerebrovascular disease
15. Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure
≥ 100 mmHg
16. Clinically significant abnormal electrocardiogram (ECG) at screening
17. Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C
18. Laboratory values outside the inclusion range (as specified in the laboratory manual and in the reports from the central laboratory) before start of study intervention, and considered clinically relevant
19. At screening:
- ALT above 2xULN OR
- AST above 2xULN OR
- total bilirubin greater than ULN OR
- AP above 2x ULN OR
- INR greater than ULN (unless on vitamin K antagonist treatment)
OR
- Positive hepatitis B virus surface antigen (HBsAg) OR
- Positive hepatitis C virus antibodies (anti-HCV) and detection of
mRNA (HCV-mRNA, only tested if hepatitis C virus antibodies were
detected)
20. Severe renal impairment as defined by estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease (MDRD) formula
21. Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g., Chronic bowel disease, Crohn’s disease and ulcerative colitis)
22. Any severe or unstable diseases or medical conditions including psychiatric disorders that might interfere with the conduct of the study, or could jeopardize the safety of the participant, or the interpretation of the results
23. History of major depression within 2 years prior to screening, or a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder)
24. Concurrent malignancy or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to screening
25. Intake of prohibited medication due to potential drug-drug interaction Use of other treatments that might interfere with the conduct of the study or the interpretation of the results e.g.
a) use of any drug treatment after start of study intervention intended for the OAB/UI symptoms other than the study intervention
b) neuromodulation therapy and intravesical treatment – less than 12 months prior to screening or at any time during the study
c) use of any treatment intended for other conditions but which can affect urinary bladder function during the study
d) Non-drug treatment (e.g. physical treatment or acupuncture) – permitted only if initiated ≥4 weeks prior to Screening and planned to be continued during the study)

E.5 End points

E.5.1

Primary end point(s)

Average change from baseline over Week 4, 8 and 12 (end of treatment [EoT]) in mean number of urgency urinary incontinence (UUI) episodes/24 hours based on electronic bladder diary

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline up to 12 weeks

E.5.2

Secondary end point(s)

1. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of Urgency urinary incontinence (UUI) episodes/24 hours
2. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of Urinary incontinence (UI) episodes/24 hours
3. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of micturition episodes/24 hours
4. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4)/24 hours
5. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of nocturia episodes/24 hours
6. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition
7. The incidence of adverse events, drug-related adverse events and taste related adverse events
8. The maximum intensity of adverse events per participant

E.5.2.1

Timepoint(s) of evaluation of this end point

1-6: From baseline up to 12 weeks
7-8: From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

100

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-05-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-01-21

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