Clinical Trials Register

Summary
EudraCT Number:	2019-001684-77
Sponsor's Protocol Code Number:	1407-0003
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-12-08
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2019-001684-77

A.3

Full title of the trial

A 12-weeks Phase II, randomized, double-blind, placebocontrolled, parallel-group, proof-of-concept trial of BI 730357 in patients with active ankylosing spondylitis

A BI 730357 vizsgálati gyógyszerkészítmény 12 hetes, II. fázisú, randomizált, kettős vak, placebo-kontrollált, párhuzamos csoportos, igazoló („proof-of-concept”) vizsgálata aktív spondyli-tis ankylopoeticában szenvedő betegek körében

A.3.1

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

A trial to test whether BI 730357 is effective in patients with active ankylosing spondylitis

A BI 730357 hatékonyságára irányuló vizsgálat aktív Bechterew-kórban szenvedő betegek körében

A.4.1

Sponsor's protocol code number

1407-0003

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 RCV GmbH & Co KG
B.1.3.4	Country	Austria
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	Boehringer Ingelheim RCV GmbH & Co KG
B.4.2	Country	Austria
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	18002430127
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 730357
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	BI 730357
D.3.9.2	Current sponsor code	BI 730357
D.3.9.3	Other descriptive name	BI 730357
D.3.9.4	EV Substance Code	SUB184416
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	200
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

axial spondyloarthritis

E.1.1.1

Medical condition in easily understood language

axial spondyloarthritis

E.1.1.2

Therapeutic area

Body processes [G] - Physical Phenomena [G01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10041672
E.1.2	Term	Spondylitis ankylosing
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this trial is to evaluate proof-of-clinical-concept (PoCC) by investigating the efficacy, safety and tolerability of BI 730357 compared to placebo in patients with active AS.

A BI 730357 hatékonyságának, biztonságosságának és tolerálhatóságának vizsgálata placebóval összehasonlítva spondylitis ankylopoeticában szenvedő betegek körében.

E.2.2

Secondary objectives of the trial

Secondary objectives are, amongst others, achievement of low disease activity or inactive disease status at Week 12.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients.
2. Age ≥ 18 years and ≤ 75 years at screening visit.
3. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial.
4. Diagnosis of AS according to modified New York criteria (1984).
5. Documented disease duration ≥ 3 months at screening visit.
6. Active disease at screening, defined as:
a. BASDAI score (0-10) ≥ 4, AND
b. Spinal pain level assessed by the 2nd BASDAI question (0-10) ≥ 4
7. Have either
a. an inadequate response for axial symptoms to at least 30 days of optimal daily
doses of at least two NSAIDs, OR
b. an intolerance to NSAIDs,
according to judgement of the investigator.
8. Women of child-bearing potential 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. Such methods should be used throughout the trial
and the patient must agree to periodic pregnancy testing during participation in the trial

E.4

Principal exclusion criteria

1. Major chronic inflammatory or connective tissue disease other than AS (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, Lyme disease, gout) or fibromyalgia, as assessed by the investigator
2. Active uveitis or uveitis within 4 weeks prior to randomization
3. Suspected or diagnosed inflammatory bowel disease
4. Previous exposure to BI 730357
5. Prior use of any therapeutic agent directly targeted to IL-17 or TNFα
6. Evidence of total ankylosis of the spine at any time in judgement of the investigator
7. Existing contraindications for an MRI examination, according to local medical standards
8. Use of the treatments:
- Leflunomide without cholestyramine wash-out within 8 weeks prior to randomisation,
- non-biologic-targeted synthetic DMARDs (e.g., JAK inhibitors, phosphodiesterase-4 inhibitors or leflunomide with cholestyramine wash-out) within 4 weeks prior to randomization
- intraarticular injection(s) (including glucocorticoids) and intramuscular or intraveneous corticosteroid treatment within 4 weeks prior to randomization
- oral glucocorticoids within 2 weeks prior to randomization

Further criteria apply.

E.5 End points

E.5.1

Primary end point(s)

1) Achievement of ASAS 40

E.5.1.1

Timepoint(s) of evaluation of this end point

1) week 12

E.5.2

Secondary end point(s)

1) Change from baseline to Week 12 in disease activity assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
2) Achievement of ASAS 20 at Week 12
3) Achievement of Low Disease Activity (Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1) at Week 12.
4) Achievement of Inactive Disease (ASDAS score of < 1.3) at Week 12.
5) Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12 as compared to baseline
6) Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 as compared to baseline
7) Achievement of Major Improvement (ASDAS improvement of >2) at Week 12 as compared to baseline
8) Achievement of ASAS 5/6 at Week 12
9) Number of patients discontinued due to drug-related AEs.
10) AEs
11) Treatment emergent AEs
12) SAEs
13) Intensity (assessed on RCTC criteria)
14) Safety Laboratory Values (haematology, clinical chemistry and urinanalysis)
15) Vital Signs

E.5.2.1

Timepoint(s) of evaluation of this end point

1) week 12
2) week 12
3) week 12
4) week 12
5) week 12
6) week 12
7) week 12
8) week 12
9) week 12
10) week 12
11) week 12
12) week 12
13) week 12
14) week 12
15) week 12

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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

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

Belgium

Czechia

Georgia

Germany

Hungary

Korea, Republic of

Moldova, Republic of

Romania

Spain

Ukraine

United States

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

2020-12-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-08-18

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials