Clinical Trials Register

Summary
EudraCT Number:	2018-000768-27
Sponsor's Protocol Code Number:	IFX-1-P2.5
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:	2018-12-19
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

2018-000768-27

A.3

Full title of the trial

A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA)

Randomizované, dvojitě zaslepené, dvojitě maskované, aktivně kontrolované, multicentrické klinické hodnocení fáze II o dvou částech za účelem náhrady steroidů přípravkem IFX-1 u aktivní granulomatózy s polyangiitidou (GPA) a mikroskopickou polyangiitidou (MPA).

A.3.1

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

Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.

A.4.1

Sponsor's protocol code number

IFX-1-P2.5

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	InflaRx GmbH
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	InflaRx GmbH
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	InflaRx GmbH
B.5.2	Functional name of contact point	InflaRx GmbH
B.5.3	Address:
B.5.3.1	Street Address	Winzerlaer Str. 2
B.5.3.2	Town/ city	Jena
B.5.3.3	Post code	07745
B.5.3.4	Country	Germany
B.5.4	Telephone number	+493641508180
B.5.5	Fax number	+493641508181
B.5.6	E-mail	info@inflarx.de

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	IFX-1
D.3.4	Pharmaceutical form	Concentrate for 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	Vilobelimab
D.3.9.2	Current sponsor code	IFX-1 (former code: CaCP29)
D.3.9.3	Other descriptive name	chimeric monoclonal antibody, IgG4 subtype
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	10
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	PredniSONE Tablets, USP
D.2.1.1.2	Name of the Marketing Authorisation holder	Par Pharmaceutical
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Glucocorticoids (GC)
D.3.4	Pharmaceutical form	Capsule, hard
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	PREDNISONE
D.3.9.1	CAS number	53-03-2
D.3.9.4	EV Substance Code	SUB10020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 10
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	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)

E.1.1.1

Medical condition in easily understood language

GPA and MPA are severe rare diseases causing pain and swelling of blood vessels and other tissues.

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	10063344
E.1.2	Term	Microscopic polyangiitis
E.1.2	System Organ Class	10047065 - Vascular disorders

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	10072579
E.1.2	Term	Granulomatosis with polyangiitis
E.1.2	System Organ Class	10047065 - Vascular disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.

E.2.2

Secondary objectives of the trial

•To assess safety and tolerability of IFX-1
•To compare GC-induced toxicity of standard-dose GC and reduced dose GC with IFX-1 treatment
•To generate data for PK and PD modelling of IFX-1 treatment.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, ≥ 18 years of age.
2. Written informed consent obtained from subject.
3. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference (CHCC).
4.History of positive antigen-specific ANCA testing since the time of diagnosis or at screening, or documented evidence of either anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) (for newly diagnosed subjects a recent positive antigen-specific ANCA testing is mandatory for inclusion)
5. Have ≥ 1 “major” item, or ≥ 3 other items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).
6. Newly diagnosed or relapsed GPA or MPA that requires treatment with CYC or RTX plus GCs.
7. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m².

E.4

Principal exclusion criteria

Subjects who fulfil any of the following criteria at screening are not
eligible to participate in the study:
1.Any other multi-system autoimmune disease as listed in Appendix
18.4.
2.Require mechanical ventilation because of alveolar hemorrhage at
screening.
3.Known hypersensitivity to any investigational medicinal product (IMP)
(i.e. GC, IFX-1) and/or any excipients.
4.Subject with rare hereditary problems of galactose intolerance, total
lactase deficiency or glucose-galactose malabsorption.
5.Have required management of infections, as follows:
a.Chronic infection requiring anti-infective therapy (such as latent
tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes
simplex virus, herpes zoster and atypical mycobacteria) within 3 months
before screening.
b.Use of intravenous antibacterials, antivirals, anti-fungals, or anti
parasitic agents within 30 days of screening.
6.Current and/or history (within the previous 5 years) of drug and/or
alcohol abuse and/or dependence.
7.Evidence of Hep B, C and/ or HIV infection. Only subjects with
documented negative historical results (within 4 weeks before
screening) for Hep B, C Virus and HIV or a negative test by Screening
can be included into the study.
8.Any of the following abnormal laboratory findings at screening:
a.White blood cells < 3,500/mm3
b.Platelet count < 100,000/mm3
c.Transaminase values (AST and/or ALT) ≥ 2.5 times the upper limit of
normal range (ULN)
d.Total bilirubin ≥ 1.5 times ULN
e.Alkaline Phosphatase (ALP) > 3 times ULN
9.Current or history of malignancy, lymphoproliferative, or
myeloproliferative disorder except squamous cell or basal cell
carcinomas of the skin and cervical carcinoma in situ with curative
surgical treatment.
10.Received CYC or RTX within 12 weeks before screening or within 12
weeks before CYC or RTX is started for remission induction within 2
weeks before screening.; If subject is on AZA, MMF or MPS or MTX, these
drugs must be discontinued prior to receiving the first dose of CYC or
RTX.
11.Received > 3 g cumulative intravenous GCs within 4 weeks before
screening (RTX intravenous GC premedication is separate and does not
count to the 3 g).
12.a.Received an oral daily dose of a GC of > 10 mg prednisoneequivalent
for more than 6 weeks continuously prior to screening.
b.Received an oral daily dose of a GC of > 80 mg prednisone equivalent
within 2 weeks before screening.
13.Received a CD20 inhibitor, anti-tumor necrosis factor treatment,
abatacept, alemtuzumab, any other experimental or biological therapy,
intravenous immunoglobulin or plasma exchange, antithymocyte
globulin, or required renal dialysis within 12 weeks before screening.
14.Received a live vaccination within 4 weeks before screening or
planned between screening and Week 2774.
15.Either active or latent tuberculosis treatment is ongoing.
16.Pregnant or lactating.
17.Clinically significant abnormal electrocardiogram (ECG) during
screening.
18.Female subjects of childbearing potential unwilling or unable to use a
highly effective method of contraception (pearl index < 1) during
treatment and for at least 3 months after last administration of IFX-
1/Placebo-IFX-1 (or up to 12 months, the timeframes for Standard of
Care agents have to be considered as described in the respective
Prescribing Information/SPCstimeframes). Contraception methods
regarded as highly effective methods and the duration of contraception
are further described in Section 7.7.
19.Evidence or suspicion that the subject might not comply with the
requirements of the study protocol.
20.The subject is an employee or direct relative of an employee of the
sponsor (InflaRx GmbH).
21.The subject is imprisoned or lawfully kept in an institution.
22.The subject has participated in an investigational clinical study during
the 12 weeks (or 5 times the half-life of the previous IMP, whichever is
longer) before screening, or plans to participate in another
investigational clinical study during their participation in this study.
23.Male subjects with female partners of childbearing potential unwilling
to use contraception (condoms) during treatment and for at least 3
months after last administration of IFX-1/Placebo-IFX-1.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the proportion of subjects achieving
clinical response defined as reduction in BVASv3 ≥ 50% at Week 16
compared to Baseline (= screening assessment) and no worsening in
any body system. Subjects who receive rescue therapy until Week 16
will be considered as not having achieved clinical response.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

E.5.2

Secondary end point(s)

1.Proportion of subjects with clinical response, defined as reduction in
BVASv3 ≥ 50% and no worsening in any body system at each
measurement time point except Week 16. Subjects who receive rescue
therapy will be considered as not having achieved clinical response at
each time point later than the first administration of rescue therapy
2.Proportion of subjects with a clinical remission defined as having a
BVASv3 = 0 at Week 16
3.Change from baseline (=screening assessment) in BVASv3 total score
at Week 16
4.Absolute values and absolute and relative change from Day 1 in the
VDI at Week 16
5.Absolute values and absolute and relative change from Day 1 in the
PGA at Week 16
6.Absolute values and absolute and relative change from Day 1 in eGFR
in mL/min/1.73 m² at Week 16.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. At weeks 0 (Day 1), 1, 2, 4, 8, 12, 20, 24
2. Week 16
3. 4. and 5. From Day 1 to week 16

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

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

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

Yes

E.8.1.7.1

Other trial design description

Double dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

Russian Federation

Belgium

Czechia

France

Germany

Italy

Netherlands

Spain

Sweden

United Kingdom

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)

Patients will return to standard of care

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

2019-01-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-06-08

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