Clinical Trials Register

Summary
EudraCT Number:	2017-003191-30
Sponsor's Protocol Code Number:	CLYS006X2201
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:	2020-01-02
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

Czechia - SUKL

A.2

EudraCT number

2017-003191-30

A.3

Full title of the trial

A randomized, subject and investigator blinded, placebo-controlled, multi-center study in parallel groups to assess the efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne

Randomizované, placebem kontrolované, multicentrické klinické hodnocení, uspořádané v paralelních skupinách a zaslepené vůči pacientům a zkoušejícímu, ke stanovení účinnosti a bezpečnosti přípravku LYS006 u pacientů se středně těžkým až těžkým zánětlivým akné

A.3.1

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

Acne

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

CLYS006X2201

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03497897

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	Novartis Pharma AG
B.1.3.4	Country	Switzerland
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	Novartis Pharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis s.r.o.
B.5.2	Functional name of contact point	Informační služba – klin. hodnocení
B.5.3	Address:
B.5.3.1	Street Address	Na Pankráci 1724/129
B.5.3.2	Town/ city	Praha 4
B.5.3.3	Post code	140 00
B.5.3.4	Country	Czechia
B.5.4	Telephone number	+420 2 25775 111
B.5.5	Fax number	+420 2 25775 205
B.5.6	E-mail	dotazy.klinickehodnoceni@novartis.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	LYS006 5 mg
D.3.2	Product code	LYS006
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	not yet defined
D.3.9.2	Current sponsor code	LYS006
D.3.9.3	Other descriptive name	LYS006
D.3.9.4	EV Substance Code	SUB182365
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	5
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	LYS006 1 mg
D.3.2	Product code	LYS006
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	not yet defined
D.3.9.2	Current sponsor code	LYS006
D.3.9.3	Other descriptive name	LYS006
D.3.9.4	EV Substance Code	SUB182365
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	1
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

Inflammatory Acne

E.1.1.1

Medical condition in easily understood language

Acne

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10000496
E.1.2	Term	Acne
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue 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

To assess efficacy of LYS006 versus placebo on facial inflammatory lesion counts in patients with moderate to severe inflammatory acne

E.2.2

Secondary objectives of the trial

To assess safety and tolerability of LYS006 in patients with moderate to severe inflammatory
acne

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The patients eligible for inclusion in this study must fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female subjects aged 18 to 45 years of age inclusive, and otherwise in good health as determined by medical history, physical examination, and vital signs.
3. Body weight between 50 and 120 kg, both inclusive, at screening.
4. Patients with papulo-pustular acne vulgaris (inflammatory acne):
- presenting at baseline with :
• 20 to 100 facial inflammatory lesions (papules, pustules and nodules),
• presenting at baseline and screening with
• no more than 2 facial inflammatory nodules or cysts,
• and a minimum number of 10 non-inflammatory facial lesions (open and closed comedones)
- who are candidates for systemic treatment and for whom in the opinion of the investigator, an appropriate previous treatment with topical anti-acne medication :
• failed,
• or was not well tolerated,
• or is not indicated (e.g., due to large body surface area affected, e.g., on the back)
5. Patients with Grade 3 (moderate) or Grade 4 (severe) IGA score assessed by the investigator at screening and baseline.
6. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

E.4

Principal exclusion criteria

The patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Previous treatment with investigational drugs at the time of screening, or within 4 weeks or 5 half-lives of baseline, whichever is longer; or more as required by local regulations.
2. Previous treatment with any topical anti-acne therapy:
• prescription treatment within 2 weeks prior to baseline
• OTC within 1 week prior to baseline
The use of medicated anti-acne creams, medicated cleansers or medicated soaps is prohibited.
3. Previous treatment with any oral/systemic anti-acne therapy:
• oral antibiotics, dapsone, oral zinc within 4 weeks prior to baseline,
•retinoids, within 3 months prior to baseline and
• hormonal therapy (within 1 month prior to baseline.
If women of child bearing potential are using oral contraception, this contraception can be used under certain conditions.
4. Previous treatment with systemic corticosteroids or immunomodulators (e.g. cyclosporine, methotrexate, azathioprine) within 4 weeks prior to baseline.
5. Previous treatment with biologics (e.g anti-TNFα agents, anti-IL-1, or anti-IL-17) within 3 months or 5 half-lives (whichever is longer) prior to baseline.
6. Previous treatment with anti-IL-12/23 blocking agents (e.g. briakinumab and ustekinumab or p19 antibodies) within 6 months prior to baseline.
7. Previous surgical, physical (such as ThermaClear™), light (including blue or UV light, photodynamic therapy) or laser therapy within 4 weeks prior to baseline.
8. Previous facial treatment with medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
9. Concomitant medication(s) known to inhibit OAT3 or BCRP and that cannot be discontinued or replaced by safe alternative medication within 5 half-lives or 1 week (whichever is longer) to baseline and for the duration of the study.
10. Any other forms of acne.
11. Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
12. Active systemic infections (other than common cold) within 2 weeks prior to baseline.
13. Subjects with eGFR <60 mL/min/1.73m2 at screening.
14. History of kidney stones and /or repeated presence of crystals in urine before drug administration.
15. History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
16. Chronic infection with Hepatitis B or C.
17. History of auto-immune or immunodeficiency diseases, or a positive HIV test result at screening.(for example, Chemiluminescence and Polymerase Chain Reaction)
18. Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
19. Women of child-bearing potential, unless they are using basic methods of contraception during dosing of study treatment.
20. History of drug abuse or unhealthy alcohol use.
21. Donation or loss of 400 ml or more of blood within 8 weeks prior to baseline, or longer if required by local regulation.
22. Inability or unwillingness to undergo repeated venipunctures.
23. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.

Other protocol-defined exclusion criteria may apply.

E.5 End points

E.5.1

Primary end point(s)

Baseline-adjusted total inflammatory facial lesion count at Week 12

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12 of treatment (Day 85)

E.5.2

Secondary end point(s)

Number and severity of adverse events

E.5.2.1

Timepoint(s) of evaluation of this end point

From Baseline visit till End of trial visit (Day 115)

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

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

tolerability and impact on patient’s quality of life

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

United States

France

Germany

Hungary

Netherlands

Czechia

E.8.7

Trial has a data monitoring committee

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)

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

2019-12-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-03-09

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