Clinical Trials Register

Summary
EudraCT Number:	2017-003101-17
Sponsor's Protocol Code Number:	1293-0013
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-02-23
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2017-003101-17

A.3

Full title of the trial

An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10

A.3.1

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

An exploratory maintenance trial of BI 655064 in patients with lupus nephritis

A.4.1

Sponsor's protocol code number

1293-0013

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 Pharma GmbH and Co. KG
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	Boehringer Ingelheim Pharma GmbH and Co. KG
B.5.2	Functional name of contact point	CT Disclosure & Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Binder 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	49800243 0127
B.5.5	Fax number	49800821 7119
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.3.1	Product name	BI 655064
D.3.2	Product code	BI 655064 120 mg (180 mg/ml)
D.3.4	Pharmaceutical form	Solution for infusion in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.2	Current sponsor code	BI 655064
D.3.9.3	Other descriptive name	BI 655064
D.3.9.4	EV Substance Code	SUB180326
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	120
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	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	Yes
D.3.11.13.1	Other medicinal product type	humanized non-depleting antagonistic therapeutic antibody
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	BI 655064
D.3.2	Product code	BI 655064 180 mg (180 mg/ml)
D.3.4	Pharmaceutical form	Solution for infusion in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.2	Current sponsor code	BI 655064
D.3.9.3	Other descriptive name	BI 655064
D.3.9.4	EV Substance Code	SUB180326
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	180
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	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	Yes
D.3.11.13.1	Other medicinal product type	humanized non-depleting antagonistic therapeutic antibody

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 injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

lupus nephritis

E.1.1.1

Medical condition in easily understood language

inflammation of the kidneys

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10025140
E.1.2	Term	Lupus nephritis
E.1.2	System Organ Class	10038359 - Renal and urinary disorders

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 main objectives of this trial are to evaluate the long term efficacy and safety of different
doses of BI 655064 versus placebo as add-on therapy to SOC during maintenance therapy for
lupus nephritis.
Since patients are randomized at the start of 1293.10 and on the same
treatment in 1293-0013, the baseline of trial 1293.10 will be used as
baseline for all assessments of change from baseline if not specified otherwise.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female patients.
- Women of childbearing potential* and men able to father a child must be ready and able
to use two reliable methods of birth control simultaneously, one of which must be highly
effective. Highly effective birth control per ICH M3(R2) is a method that result in a low
failure rate of less than 1% per year when used consistently and correctly. The reliable
methods of birth control must be used before starting MMF/AZA and the trial drug; then
continue during the trial period; and for at least 50 days after the last dose of MMF/AZA
and trial medication. A list of contraception methods meeting these criteria is provided in
the patient information.
- Sexually active men must be ready to use condoms ** during treatment with MMF and
for at least 90 days after cessation of MMF.
* A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming
postmenopausal unless permanently sterile.
- Permanent sterilisation methods include hysterectomy, bilateral oophorectomy and bilateral
salpingectomy.
- Tubal ligation is NOT a method of permanent sterilisation.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
** Condoms are applied for both reproductively competent and vasectomised men, because the risks
associated with the transfer of seminal fluid also apply to men who have had a vasectomy. In addition,
female partners of male patients treated with MMF are recommended to use highly effective
contraception during treatment and for a total of 90 days after the last dose of MMF.

Definition of highly effective contraceptives:
• The use of hormonal methods of contraception associated with inhibition of ovulation (either combined oestrogen and progestogen containing hormonal contraception, or progestogen-only hormonal contraception)
• Placement of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomised sexual partner
• Complete sexual abstinence
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

For Group 1 patients only:
- Achieved either a CRR or a PRR or proteinuria ≤ 1g/d (or UP/UC ≤ 1) at the end of 1293.10.

For Group 2 patients :
Group 2 was cancelled, therefore all inclusion criteria were cancelled.

E.4

Principal exclusion criteria

Evidence of current or previous clinically significant diseases or medical conditions
other than lupus, or findings of the medical examination (including vital signs and ECG)
that, in the opinion of the investigator, would compromise the safety of the patient or the
quality of the data. This criterion provides an opportunity for the investigator to exclude
patients based on clinical judgment, even if other eligibility criteria are satisfied.
- Significant central nervous system symptoms related to SLE based on investigators
assessment.
- Clinically important acute or chronic infections including but not limited to HIV,
hepatitis B or C.
- Impaired hepatic function defined as serum AST/ALT, bilirubin or alkaline phosphatase
> 2 x ULN.
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening (using
CKD-EPI formula).
- Known hypersensitivity to any constituents of the trial medication; and/or
contraindications to MMF or AZA or glucocorticoids.
- The use of any restricted medications (see section 4.2.3.1) or any drug considered likely
to interfere with the safe conduct of the trial.
- Unable to comply with the protocol in the investigator’s opinion.
- Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes
them an unreliable trial patient or unlikely to complete the trial.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

For Group 2 patients only:
Group 2 was cancelled, therefore all exclusion criteria were cancelled.

E.5 End points

E.5.1

Primary end point(s)

1) proportion of patients with complete renal reponse (CRR) and without any renal flares

E.5.1.1

Timepoint(s) of evaluation of this end point

1) week 52

E.5.2

Secondary end point(s)

1) Proportion of patients with CRR at week 52
2) Proportion of patients with proteinuria <0.8g/d and without any renal flares at week 52.
3) Proportion of patients with CRR at week 52 and sustained steroid reduction to ≤5 mg/d from week 26 to week 52.
4) Proportion of patients experiencing at least one renal flare during 52 weeks.
5) Time to first renal flare over the course of 52 weeks.
6) Proportion of patients with confirmed CRR (defined as CRR at both week 42 and week 52 using UP/UC from spot urine)
7) Change from baseline in SLEDAI at weeks 12, 26, 42 and 52.

E.5.2.1

Timepoint(s) of evaluation of this end point

1) week 52
2) week 52
3) at week 52 and from week 26 to week 52.
4) week 52
5) throughout the trial until week 52.
6) week 42 and week 52
7) at weeks 12, 26, 42 and 52.

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

Australia

Canada

Hong Kong

Japan

Korea, Republic of

Malaysia

Mexico

Philippines

Thailand

United States

Germany

Greece

Poland

Portugal

United Kingdom

Czechia

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

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

150

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

2018-04-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-02-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-07-27

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