Clinical Trials Register

Summary
EudraCT Number:	2021-006820-41
Sponsor's Protocol Code Number:	LYT-100-2022-204
National Competent Authority:	Romania - National Agency for Medicines and Medical Devices
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2024-10-17
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

Romania - National Agency for Medicines and Medical Devices

A.2

EudraCT number

2021-006820-41

A.3

Full title of the trial

A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF).

A.3.1

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

A Randomized Double-blind Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis

A.4.1

Sponsor's protocol code number

LYT-100-2022-204

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05321420

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	PureTech LYT 100, Inc.
B.1.3.4	Country	United States
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	PureTech LYT 100, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	PureTech LYT 100, Inc.
B.5.2	Functional name of contact point	Sarah Santipadri
B.5.3	Address:
B.5.3.1	Street Address	6 Tide Street, Suite 400
B.5.3.2	Town/ city	Boston
B.5.3.3	Post code	MA 02210
B.5.3.4	Country	United States
B.5.6	E-mail	clinicaltrials@puretechhealth.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	Yes
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	deupirfenidone
D.3.2	Product code	LYT-100
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	deupirfenidone
D.3.9.2	Current sponsor code	LYT-100
D.3.9.3	Other descriptive name	Pirfenidone, deuterated
D.3.9.4	EV Substance Code	SUB217017
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	275
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	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.2.5	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	pirfenidone
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	Pirfenidone
D.3.9.3	Other descriptive name	Pirfenidone
D.3.9.4	EV Substance Code	SUB09907MIG
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	267
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: 3
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	deupirfenidone
D.3.2	Product code	LYT-100
D.3.4	Pharmaceutical form	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	deupirfenidone
D.3.9.2	Current sponsor code	LYT-100
D.3.9.3	Other descriptive name	Pirfenidone, deuterated
D.3.9.4	EV Substance Code	SUB217017
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	275
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	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

Idiopathic Pulmonary Fibrosis (IPF)

E.1.1.1

Medical condition in easily understood language

Lung scarring of the unknown cause

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

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	10021240
E.1.2	Term	Idiopathic pulmonary fibrosis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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

• To obtain clinical data establishing the efficacy, tolerability, safety, and dosing regimen of LYT-100 in patients with IPF.

E.2.2

Secondary objectives of the trial

Part B Objectives:
• Assess the safety and tolerability of long-term treatment with LYT-100 in the IPF population
• Compare the rate of change in FVC through the end of Part B Period 1 to that observed during Part A, by Part A treatment group assignment and by Part B LYT-100 target dose

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

Intensive PK Sub-study:
An optional, intensive PK sub-study will be conducted at a subset of sites in approximately 8 completed patients per treatment arm in which each patient will provide up to 16 blood samples for PK over a 24-hour period at Study Visits 3, 5 and 8.

E.3

Principal inclusion criteria

1.Written or electronic informed consent from the patient prior to any study procedures in a manner approved by an IRB or Ethics Committee (EC)
2.Male or female, age of ≥40 years at the time of informed consent
3.Able to perform and willing to comply with all study procedures and requirements
4.Treatment-naïve patients or patients <6 months of previous
exposure to nintedanib with physician-diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
5.Idiopathic Pulmonary Fibrosis on high-resolution computed
tomography (HRCT), performed within 12 months of Visit 1 as confirmed by central readers
6.The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan as determined by the investigator and the central reader
7.Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin (Hb) [Visit 1] ≥30% and <90% of predicted normal where available at the study site
8.FVC ≥45% of predicted normal
9.Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must be abstinent from heterosexual intercourse throughout the study and for 30 days following last dose of study medication or agree to use one of the acceptable, highly effective methods of double contraception which is defined as male use of a condom AND one form of the following:
a. oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation
b. oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
c. intrauterine device (IUD)
10. Male participants must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or, if engaged in heterosexual relations, any female partner must be postmenopausal, surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period and for no less than 90 days after the last dose of study medication along with the use of male condom
11. Males will not donate sperm for at least 90 days after the last dose of study medication
12. Female partners of male participants and female participants will report pregnancy occurring within 90 days from cessation of study medication
Part B:
1.Signed informed consent for Part B prior to any study-mandated
procedures
2.Participant must have completed Part A of the study, through Day 183 of treatment
3.In the opinion of the investigator, the participant is a good candidate for continued treatment

E.4

Principal exclusion criteria

1.Participants who, in the judgement of the investigator, are unlikely to be able to fulfill study participation requirements
2.Significant clinical worsening (as per i4nvestigator’s discretion) of IPF between Screening and Baseline Visits
3.AST or ALT >1.5 × ULN at Visit 1
4.Total bilirubin >1.5 × ULN at Visit 1. Exceptions may be made on a case-by-case basis for participants with Gilbert's syndrome in consultation with the medical monitor
5. Creatinine clearance <30 mL/min calculated by Cockcroft–Gault formula at Visit 1
6. Participants with underlying chronic liver disease (Child- Pugh B, or C hepatic impairment)
7.Current or prior treatment with pirfenidone
8.Other investigational therapy received within 1 month prior to randomization visit (Visit 2)
9.Significant pulmonary arterial hypertension (PH) defined by any of the following:
a.Previous clinical or echocardiographic evidence of significant right heart failure
b.History of right heart catheterization showing a cardiac index ≤2 L/min/m²
c.PH inhaled requiring subcutaneous or intravenous therapy with epoprostenol/treprostinil
d.In the principal investigator's opinion, the study participant's
symptoms are more related to their PH than to their IPF
10.Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC <0.7 at Visit 1)
11.Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
12.Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, Sjogren's disease, mixed connective tissue diseases, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
13.In the opinion of the investigator, other clinically significant pulmonary abnormalities, including prior or current lung cancer (treated within the past 5 years)
14.Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)
15.Cardiovascular diseases, any of the following:
a.Uncontrolled hypertension within 3 months of Visit 1
b.Myocardial infarction within 6 months of Visit 1
c.Unstable cardiac angina within 6 months of Visit 1
16.Prior hospitalization within 3 months prior to Visit 1 for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection
17.Known symptoms of dysphagia or known difficulty in swallowing capsules or tablets and/or total gastrectomy
18.Use of any of the following drugs within 2 weeks prior to Visit 2/baseline, or planned during the duration of the study
a.Strong and moderate CYP1A2 inhibitors (i.e., ciprofloxacin, fluvoxamine, enoxacin, methoxsalen, mexiletine, vemurafenib) and
phenytoin, rifampin, and teriflunomide (inducers of CYP1A2)
b.Medications associated with substantial risk for prolongation of the QTc interval (including but not limited to moxifloxacin, quinidine, procainamide, amiodarone, sotalol)
c.Immunosuppressant medications such as azathioprine, cyclophosphamide, cyclosporin A, methotrexate, prednisone at a steady dose >10mg/day or equivalent
d.Medications used to treat PH such as endothelin receptor antagonists (eg. ambrisentan, bosentan, and macitentan), phosphodiesterase-5 inhibitors (sildenafil and tadalafil used to treat erectile dysfunction are allowed) guanylate cyclase stimulators (eg, riociguat), prostacyclin analogs (eg, epoprostenol, treprostnil, iloprost), or prostacyclin receptor agonists (eg, selexipag)
e.Warfarin, as it may worsen IPF
f. Vaccination with a live vaccine is not permitted during the period from 4 weeks prior to Screening to 4 weeks after the last dose.
19.A current immunosuppressive condition (e.g., HIV)
20.Major surgical procedures during screening or study periods, with the exception of pre-planned procedures that will not interfere with study participation
21. Active alcohol or drug abuse
22. Use of smoked (burnt) tobacco products or vaping/e-cigarettes
23. Other disease (including malignancy) that may interfere with testing procedures or in the judgement of the investigator may interfere with study participation or may put the participant at risk when participating in this study
24. Participants with a documented hypersensitivity to LYT-100
25. Participants with a documented lactose or galactose intolerance
Part B:
1.Participants must not meet any exclusion criteria listed for Part A
2.Participants who discontinued study medication and started receiving
commercially available antifibrotic medication during Part A will not be eligible for Part B
3.Participants whose treatment assignment is unblinded during Part A will not be eligible for Part B
4.AST, ALT, or total bilirubin >3 × ULN
5.Any known factor or disease that interferes with treatment
compliance, study conduct, or interpretation of the results, as judged by the investigator

E.5 End points

E.5.1

Primary end point(s)

• Rate of decline in FVC (in mL) over Part A (26 weeks)

E.5.1.1

Timepoint(s) of evaluation of this end point

at week 26

E.5.2

Secondary end point(s)

Key Secondary Efficacy Endpoints:
• Change in FVC % predicted (FVCpp) from baseline to the end of Part A (Week 26)
Secondary Efficacy Endpoints:
• Time to IPF progression through 26 weeks (the end of Part A), as defined by a decline from baseline in FVCpp of 5% or greater, or death
• Time to hospitalization due to respiratory cause (as determined by the investigator) or all-cause mortality through 26 weeks
Secondary Tolerability Endpoints:
• Incidence of dose modifications (dose reductions and interruptions)
• Time to first dose modification (reduction or interruption)
• Duration of dose modifications (reductions and interruptions)
•Number of days on full assigned dose
• Incidence and duration of AESIs
• Time to treatment discontinuation due to an AE
• Change from baseline to Week 26 in PGI-C cough
Exploratory Endpoints:
• Time to hospitalization due to respiratory cause (as determined by the investigator) through 26 weeks
• Time to all-cause mortality through 26 weeks
• Change from baseline to Week 26 in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) total score
• Change from baseline to Week 26 in St. George’s Respiratory Questionnaire – IPF Version (SGRQ-I)
• Change from baseline to Week 26 in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D)
• Change in serum biomarkers from baseline through Week 26
• Number and duration of respiratory hospitalizations or pulmonary
exacerbations (as determined by the investigator) through 26 weeks
•Rate of hospitalization due to respiratory cause (as determined by the investigator) through 26 weeks
Part B
Key Secondary Efficacy Endpoints
• Change in FVCpp from the end of Part A (Week 26) to the end of Part B Period 1 (Week 52)
• Rate of decline in FVC (in mL) from the end of Part A (Week 26) to the end of Part B Period 1 (Week 52) using the values obtained from spirometry assessments
Secondary Efficacy Endpoints
• Time to IPF progression in Part B, as defined by a decline from the end of Part A (Week 26) to the end of Part B Period 1 (Week 52) in FVCpp of 5% or greater, or death
Secondary Tolerability Endpoints
• Incidence of dose modifications (dose reductions and interruptions)
• Time to first dose modification (reduction or interruption)
• Duration of dose modifications (reductions and interruptions)
• Number of days on full assigned dose
• Incidence and duration of AESIs
• Time to treatment discontinuation due to an AE
Exploratory Endpoints
• Time to hospitalization due to respiratory cause (as determined by the investigator) from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
• Time to all-cause mortality from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
• Time to hospitalization due to respiratory cause (as determined by the investigator) or all-cause mortality from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
• Total duration on assigned dose from the start of Part B through the
end of Part B Period 1 (Week 52)
• Change in EQ-5D from the end of Part A (Week 26) through the end of Part B Period 1 (Week 52)
• Change in serum and plasma biomarkers from the end of Part A (Week 26) through the end of Part B Period 1 (Week 52)
• Number and duration of respiratory hospitalizations or pulmonary
exacerbations (as determined by the investigator) from the start of Part B (Week 26) through the end of PartB Period 1 (Week 52)
• Rate of hospitalization due to respiratory cause (as determined by the investigator) from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
Pharmacokinetic Endpoints
A sparse PK sampling strategy will be employed in which all participants will provide pre-dose blood samples for determination of plasma
concentrations of LYT-100/pirfenidone and its metabolite(s). In
addition, an optional, intensive PK substudy will be conducted at a
subset of sites in approximately 8 completed participants per treatment arm in which each participant will provide up to 16 blood samples for PK over a 24-hour period at Study Visits 3, 5 and 8.

E.5.2.1

Timepoint(s) of evaluation of this end point

at week 26 (Part A)
at week 52 (Part B)

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

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

Yes

E.8.1.7.1

Other trial design description

Double-blind Part A is followed by Part B long-term open-label extension

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

Argentina

Chile

Colombia

Malaysia

Georgia

India

Korea, Republic of

Mexico

Serbia

South Africa

Thailand

United States

Greece

Poland

Romania

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:

150

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)

All participants will return for a follow-up visit 28 days following their
last dose of study medication if they do not enter Part B, in which case
this visit will be performed 4 weeks after the end of treatment in Part
B.

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

2022-08-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-10-19

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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Select Trial Status:	Select Trial Phase:
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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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