Clinical Trials Register

Summary
EudraCT Number:	2017-003090-34
Sponsor's Protocol Code Number:	1368-0008
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-06-15
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

Denmark - DHMA

A.2

EudraCT number

2017-003090-34

A.3

Full title of the trial

Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease

A.3.1

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

A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease

A.3.2

Name or abbreviated title of the trial where available

BI 655130 treatment of fistulizing CD

A.4.1

Sponsor's protocol code number

1368-0008

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	Boehringer Ingelheim BV
B.1.3.4	Country	Netherlands
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	This is Boehringer Ingelheim B.V
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim Pharma GmBH & Co. KG
B.5.2	Functional name of contact point	CT Disclosure & Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	498002430127
B.5.5	Fax number	498008217119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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.3.2	Product code	BI 655130
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Spesolimab
D.3.9.2	Current sponsor code	BI 655130
D.3.9.3	Other descriptive name	MONOCLONAL ANTIBODY ANTI-IGG1
D.3.9.4	EV Substance Code	SUB31544
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Fistulizing Crohn’s Disease

E.1.1.1

Medical condition in easily understood language

Fistulizing Crohn’s Disease

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10075465
E.1.2	Term	Fistulizing Crohn's disease
E.1.2	System Organ Class	100000004856

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 explore the pathomechanisms involved in the generation and healing of CD associated
perianal fistulas
- To understand the MoA of BI 655130 in patients with CD and draining perianal fistulas

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Multispectral Optoacoustic Tomography (MSOT)
MSOT allows precise localization of specific molecules in tissues through the photoacoustic
effect. This effect describes the observation that light absorbed by molecules is inducing
thermoplastic expansion, which can be detected as ultrasound waves with very high spatial
resolution.
MSOT to be performed in patients recruited by a site where imaging technology is available.

E.3

Principal inclusion criteria

Each patient of Screening Cohort and Study Cohort must meet all of the following inclusion
criteria to be included into the trial:
1. 18-75 years at date of signing informed consent
2. Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and
able to use highly effective methods of birth control per ICH M3 (R2) that result in a low
failure rate of less than 1% per year when used consistently and correctly. A list of
contraception methods meeting these criteria are provided in section 4.2.2.3 Restrictions
regarding women of childbearing potential. Restrictions regarding contraception for
female patients are not applicable for Screening Cohort.
3. Diagnosis of clinical Crohn´s Disease ≥ 3 months prior to screening by clinical and
endoscopic evidence and corroborated by a histopathology report
4. Has ≥ 1 perianal active* fistula(s) with clinical indication for seton drainage (≥ 4 weeks duration before enrolment, as a complication of
CD)**.
*Criteria for Active Fistula: As per clinical evaluation: Presence of spontaneous drainage or drainage after gentle finger compression at the external openings & as confirmed by radiological (MRI) exploration.
**Patients who are screened with a seton drainage in place are eligible provided the drainage has not been in place for > 3 months and the patient meets the rest of the eligibility criteria
5. Additional enterocutaneous or abdominal fistulas are permitted (except rectovaginal
fistulas)
6. Absent, mild or moderate clinical activity with CDAI < 250. CDAI is not applicable for
Screening Cohort.
7. Demonstrated in the past inadequate response or loss of response or have had
unacceptable side effects with approved doses of at least one of the following
compounds: Immunesuppressive agents (e.g. thiopurines, methotrexate),
TNFɑ antagonists (e.g. infliximab, adalimumab, certolizumab pegol; or respective
biosimilars), vedolizumab, ustekinumab, azathioprine and / or antibiotics
8. Patients with family history of colorectal cancer or personal history of increased
colorectal cancer risk must have had a negative ileocolorectal cancer screening within <1
year prior to screening per local guidance (otherwise to be done during screening
ileocolonoscopy).
9. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial

E.4

Principal exclusion criteria

1. Complications of Crohn’s Disease such as symptomatic strictures, functional stenosis
distal from fistula(s), short gut syndrome, or any other manifestation that might require
surgery, could preclude the use of the PDAI and CDAI to assess response to therapy, or
would possibly confound the evaluation of benefit from treatment with BI 655130
2. Rectovaginal fistulas
3. Anticipated to require surgical intervention for CD including any fistula surgical procedures (except seton drainage). See Table 4.2.2.2:1 for a detailed list of restricted interventions
4. Has an abscess that the investigator feels requires drainage beyond fistula drainage with a
seton (based on either clinical assessment or MRI)
5. Any kind of bowel resection or diversion within 6 months or any other intraabdominal
surgery within 3 months prior to screening.
6. Ileostomy, colostomy or known fixed symptomatic stenosis of the intestine at screening.
7. Positive stool examinations for C. difficile or other intestinal pathogens < 30 days prior to
screening
8. Evidence of colonic mucosal dysplasia or colonic adenomas, unless properly removed
(properly according to the investigator’s assessment)
9. Faecal transplant ≤ 6 months before screening

Further criteria apply.

E.5 End points

E.5.1

Primary end point(s)

1) Total number of deregulated genes at week 4

E.5.1.1

Timepoint(s) of evaluation of this end point

1) week 4

E.5.2

Secondary end point(s)

1) Proportion of patients with perianal fistula response at week 12
2) Proportion of patients with perianal fistula remission at week 12
3) Proportion of patients with combined perianal fistula remission at week 12

E.5.2.1

Timepoint(s) of evaluation of this end point

1) week 12
2) week 12
3) week 12

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Austria

Belgium

Denmark

Germany

Hungary

Korea, Republic of

Netherlands

Spain

E.8.7

Trial has a data monitoring committee

Yes

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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

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

F.4.2.2

In the whole clinical trial

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

2020-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-12

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-07-04

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