Clinical Trials Register

Summary
EudraCT Number:	2022-002140-51
Sponsor's Protocol Code Number:	INV-CL-106
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-09-30
Trial 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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2022-002140-51

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients with Diabetic Kidney Disease

2. fázisú, randomizált, kettős-vak, placebo-kontrollos vizsgálat a diabéteszes vesebetegségben szenvedő betegeken két dózisban alkalmazott INV-202 hatásosságának, biztonságosságának és farmakokinetikájának értékelésére

A.3.1

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

Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease

2. fázisú vizsgálata diabéteszes vesebetegségben szenvedő betegeken

A.3.2

Name or abbreviated title of the trial where available

Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease

A.4.1

Sponsor's protocol code number

INV-CL-106

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05514548

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	Inversago Pharma Inc.
B.1.3.4	Country	Canada
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	Inversago Pharma Inc.
B.4.2	Country	Canada
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Inversago Pharma Inc.
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	1100 Rene-Levesque West Boulevard Suite 1110
B.5.3.2	Town/ city	Montreal
B.5.3.3	Post code	H3B 4N4
B.5.3.4	Country	Canada
B.5.4	Telephone number	+1 438-300-2534
B.5.5	Fax number	N/A
B.5.6	E-mail	info@inversago.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	INV-202
D.3.2	Product code	INV-202
D.3.4	Pharmaceutical form	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	Not yet available
D.3.9.1	CAS number	2712480-46-9
D.3.9.2	Current sponsor code	INV-202
D.3.9.4	EV Substance Code	SUB268905
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	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.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	INV-202
D.3.2	Product code	INV-202
D.3.4	Pharmaceutical form	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	Not yet available
D.3.9.1	CAS number	2712480-46-9
D.3.9.2	Current sponsor code	INV-202
D.3.9.4	EV Substance Code	SUB268905
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.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	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

Diabetic Kidney Disease

diabéteszes vesebetegségben szenvedő

E.1.1.1

Medical condition in easily understood language

Diabetic Kidney Disease

diabéteszes vesebetegségben szenvedő

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	24.0
E.1.2	Level	LLT
E.1.2	Classification code	10084917
E.1.2	Term	Diabetic kidney disease
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 effect of INV-202 on albuminuria, UACR in participants with DKD

Az INV-202 által az albuminuriára, a vizelet albumin/kreatinin arányra (UACR) gyakorolt hatás értékelése diabéteszes vesebetegségben (diabetic kidney disease, DKD) szenvedő résztvevőknél

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of INV-202
To evaluate the PK of INV-202 and its metabolite (desacetyl-INV-202)
To evaluate the effects of INV-202 on eGFR

Az INV-202 biztonságosságának és tolerálhatóságának értékelése
Az INV-202 és metabolitja (dezacetil-INV-202) farmakokinetikájának (PK) értékelése
Az INV-202 által a becsült glomeruláris filtrációs rátára (eGFR) gyakorolt hatás értékelése

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Male and female participants ≥18 years of age.
2.Able and willing to give informed consent and to comply with scheduled visits and trial procedures.
3.A diagnosis of DKD due to T1DM or T2DM (diagnosed for ≥1 year).
4.On a stable anti-diabetic medication regimen for ≥4 months prior to randomization with a HbA1c <9.5%
a. Participants with T1DM may not be on any glucose-lowering medications beyond insulin.
b. Participants with T2DM may be on more than 1 anti-diabetic medication regimen (eg, a sodium-glucose transport protein 2 (SGLT2) inhibitor, insulin, or other anti-diabetic medication regimen).
c. HbA1c should have been performed within the last 4 months prior to randomization.
5.Participants must be on a stable dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for ≥4 months prior to randomization and expected to remain stable for the 4-month treatment period.
6.Participants taking finerenone (not required), on a stable dose for ≥4 months prior to randomization.
7.Presence of albuminuria with a UACR >100 mg/g and <3000 mg/g at screening.

1.≥ 18 éves férfi vagy nő résztvevők.
2.Képes és kész tájékozott beleegyezést adni és együttműködni a tervezett vizitek és vizsgálati eljárások során.
3.DKD diagnózisa (≥1 éve) T1DM vagy T2 DM miatt
4.A randomizálás előtt ≥4 hónapja változatlan antidiabetikus gyógyszeres kezelést kap, és hemoglobin A1c (HbA1c) értéke <9,5%.
a.A T1DM-ben szenvedő résztvevők az inzulinon kívül nem feltétlenül kapnak vércukorcsökkentő gyógyszereket.
b.A T2DM-ben szenvedő résztvevők kaphatnak 1-nél több antidiabetikus gyógyszeres kezelést (pl. SGLT2 gátlót, inzulint vagy más antidiabetikus gyógyszeres kezelést).
c.A HbA1c szintet a randomizálást megelőző, utolsó 4 hétben kell mérni.
5.A résztvevőnek változatlan adagban ACEi-t vagy ARB-t kell kapnia a randomizálást megelőző ≥4 hónapban, és várhatóan változatlan adagot fog kapni a 4 hónapos kezelési szakaszban.
6.Finerenont (nem szükséges) szedő résztvevők, akik a randomizálást megelőző ≥4 hónapban változatlan adagot kapnak.
7.Albuminuria fennállása, ahol az UACR >100 mg/g és <3000 mg/g a szűréskor.

E.4

Principal exclusion criteria

1. Significant medical condition, that in the opinion of the Investigator will place the participant at risk during the study or that will confound the study endpoints.
2. Participants not fully vaccinated for COVID-19.
3. Other causes of kidney disease that are not DKD (eg, lupus nephritis). Of note, hypertension is not an exclusion criterion.
4. Participants with an eGFR <30 ml/min/1.73 m².
5. Participants who have had acute kidney injury (AKI) within the past 3 months, or have ever received dialysis.
6. Participants with a history of epilepsy or intracranial surgery.
7. Uncontrolled hypertension with measurements of systolic pressures >160mmHg or diastolic measurements >100mmHg at the Screening Visit.
8. Active substance abuse including inhaled or injection drugs in the year prior to screening.
9. Use of cannabis or cannabinoid containing compounds within 90 days prior to screening.
10. Pregnancy, planned pregnancy, potential for pregnancy or unwillingness to use effective birth control during the trial, as well as breast feeding
11. Evidence of moderate to severe hepatic impairment as defined by Child’s Pugh score B or C.
12. Subjects with a history of significant psychiatric disorder.
13. Score of the PHQ-9 ≥15 at baseline.
14. Current or active malignancy within the past 5 years, except for cancer in situ, or non-melanoma skin cancer such as basal cell or squamous cell carcinoma that has been completely resected.
15. QTc >500 msec at baseline.
16. Any chronic medications started or changed within the past 3 months or at risk of needing to be changed during the study.
17. Participants with a history of hyperthyroidism or other thyroid diseases.
18. Participants taking a strong inducer or inhibitor of cytochrome P450, 3A4, 2D6 or 2C19 by screening. These medications are prohibited during the entire study duration.
19. Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the Screening Visit.

1. Jelentős egészségi állapot, amely a vizsgáló véleménye szerint kockázatnak teszi ki a résztvevőt a vizsgálat alatt, vagy amely befolyásolja a vizsgálat végpontjait.
2. A koronavírus betegség 2019 (COVID-19) ellen nem teljeskörűen oltott résztvevők.
3. A vesebetegségnek más oka van, nem a DKD (pl. lupus nephritis). Megjegyzendő, hogy a hypertensio nem kizárási kritérium.
4. A résztvevő eGFR értéke <30 ml/perc/1,73 m².
5. A résztvevőnek akut vesekárosodása (acute kidney injury, AKI) volt az elmúlt 3 hónapban, vagy valaha dializálták.
6. A résztvevő anamnézisében epilepsia vagy intracranialis műtét szerepel.
7. Nem kontrollált hypertensio, ahol a szisztolés vérnyomás >160 Hgmm vagy a diasztolés vérnyomás >100 Hgmm a szűrési viziten.
8. Aktív szerabúzus, beleértve az inhalációs és injekciós drogokat a szűrést megelőző évben.
9. Kannabisz vagy kannabinoid tartalmú vegyület használata a szűrést megelőző 90 napban.
10. Terhesség, tervezett terhesség, terhesség lehetősége, vagy a résztvevő nem akar hatékony fogamzásgátlást alkalmazni a vizsgálat alatt, valamint szoptatás.
11. Igazolt középsúlyos vagy súlyos májkárosodás, ami a meghatározás szerint Child’s-Pugh B vagy C stádiumú.
12. Olyan betegek, akiknek kórtörténetében jelentős pszichiátriai kórkép, többek között az alábbiak valamelyike szerepel.
13. A kilenc kérdéses Betegegészségügyi kérdőívvel (PHQ-9) kapott pontszám ≥15 a kiinduláskor.
14. Aktuális vagy aktív malignitás az előző 5 évben, az in situ rák és a nem melanómás bőrrák, így a basalis sejtes vagy laphámsejtes karcinóma kivételével, amelyet teljesen eltávolítottak.
15. QTc >500 msec a kiinduláskor.
16. Tartós gyógyszerszedés, amely az elmúlt 3 hónapban kezdődött vagy módosult, vagy fennáll a lehetőség, hogy a vizsgálat alatt módosítani kell.
17. A résztvevő anamnézisében hipertireózis vagy más pajzsmirigybetegség szerepel.
18. A résztvevő erős citokróm P450 3A4 2D6 vagy 2C19 induktort vagy inhibitort szedett a szűrésig. Ilyen gyógyszerek alkalmazása a vizsgálat teljes időtartama alatt tilos.
19. Vizsgálati készítmény alkalmazása a szűrési vizitet megelőző 30 napban vagy a gyógyszer felezési idejének 5-szörös időtartamán belül, a hosszabbat figyelembe véve.

E.5 End points

E.5.1

Primary end point(s)

Change in UACR from baseline to W16

Az UACR változása a kiindulástól a 16. hétig

E.5.1.1

Timepoint(s) of evaluation of this end point

W16

16. hétig

E.5.2

Secondary end point(s)

Change in urine protein to creatinine ratio (UPCR) from baseline to W16
Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16
Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16

A vizelet fehérje/kreatinin arány (urine protein to creatinine ratio, UPCR) változása a kiindulástól a 16. hétig
A szérum kreatinin és a Krónikus Vesebetegség Epidemiológiai Együttműködés (Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI) képletével számolt eGFR változása a kiindulástól a 16. hétig
A cisztatin C és a CKD-EPI képlettel számolt eGFR változása a kiindulástól a 16. hétig

E.5.2.1

Timepoint(s) of evaluation of this end point

W16

16. hétig

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

Yes

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

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

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

Canada

Israel

Mexico

United States

Georgia

Hungary

Serbia

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 (last visit of the last subject)

Az utolsó vizsgálati alany utolsó vizitje

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:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

120

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

240

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)

Standard of care

Az ellátás színvonala

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

2022-12-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-10-28

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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