Clinical Trials Register

Summary
EudraCT Number:	2016-001531-12
Sponsor's Protocol Code Number:	LRP/LNP1955/2016/003
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-06-15
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2016-001531-12

A.3

Full title of the trial

A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, and Safety of LNP1955 in Patients with Moderate-to-Severe Plaque Psoriasis

II. fázisú, dózistartomány-kereső, feltáró klinikai vizsgálat az LNP1955 hatásosságának, farmakodinámiájának és biztonságosságának értékelésére mérsékelten súlyos és súlyos, plakkos pikkelysömörben szenvedő betegek esetében

A.3.1

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

Phase II study to assess the safety and efficacy of LNPP1955 in patients with psoriasis

A.4.1

Sponsor's protocol code number

LRP/LNP1955/2016/003

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	Lupin Limited
B.1.3.4	Country	India
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	Lupin Limited
B.4.2	Country	India
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Lupin Limited
B.5.2	Functional name of contact point	Project Director
B.5.3	Address:
B.5.3.1	Street Address	Research park, Survey No 46A/47A,
B.5.3.2	Town/ city	Nande Village, Mulshi Taluka, District Pune
B.5.3.3	Post code	412115
B.5.3.4	Country	India
B.5.4	Telephone number	009166749029
B.5.5	Fax number	009166749563
B.5.6	E-mail	rajeshkumawat@lupin.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.3.2	Product code	LNP1955
D.3.4	Pharmaceutical form	Capsule, soft
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.3.9.2	Current sponsor code	LND400111
D.3.9.3	Other descriptive name	LND400111
D.3.9.4	EV Substance Code	SUB177091
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.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, soft
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

Moderate to severe plaque psoriasis

E.1.1.1

Medical condition in easily understood language

Psoriasis

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	LLT
E.1.2	Classification code	10071117
E.1.2	Term	Plaque psoriasis
E.1.2	System Organ Class	100000018190

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 primary objectives of the study are as follows:
• To assess the POE of LNP1955 and find an optimum dose in patients
with moderate-to-severe plaque psoriasis

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are as follows:
• To assess the PD and safety of LNP1955 in comparison to placebo;
• To explore the pharmacokinetics (PK) of LNP1955 and synergy with
MTX in patients with moderate-to-severe plaque psoriasis in an open label study arm.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients will be enrolled in the Main part and MTX Add-on part of the
study only if they meet all of the following criteria:
1. Male or female ambulatory patients aged 18 to 75 years (both
inclusive) diagnosed with moderate-to-severe chronic stable plaque
psoriasis with active disease, PASI score of ≥ 10 and affected BSA ≥
10% and willing to provide informed consent;
2. Plaque psoriasis for at least 6 months prior to first dose of IP;
3. Are a candidate for phototherapy, photochemotherapy, or systemic
therapy of plaque psoriasis (either naive or history of previous
treatment);
4. Have not taken biologics within 6 months prior to administration of IP
in this study;
5. Have not received systemic non-biologic psoriasis therapy (including,
but not limited to, retinoids or vitamin D analogs, cyclophosphamide,
cyclosporine, fumaric acid esters, pimecrolimus, or psoralen plus
ultraviolet A light [PUVA]) or phototherapy within 4 weeks before the
first dose of IP;
6. Have not received topical psoriasis treatment within 2 weeks before
the first dose of IP;
7. Sexually active women of childbearing potential and men must be
willing to use a reliable means of contraception (e.g. combined or
progestogen only hormonal contraception, intrauterine devices [IUDs],
surgical sterilization, double barrier, or vasectomized partner) during
participation in this study and at least 2 months after the last dose of the
IP OR postmenopausal women (aged greater than 45 years) with a
history of amenorrhea for at least 1 year from the time of last menstrual
cycle and have follicle-stimulating hormone (FSH) value indicating
menopause with high reliability. Additional Inclusion Criteria for Main
part: 1. Have not received MTX within 6 weeks prior to first dose of IP.
Additional Inclusion Criteria for MTX Add-on part:
1. MTX naive and eligible to receive 7.5 mg MTX per week after having
tolerated at least one dose (OR);
2. Patients receiving stable dose of 7.5 mg MTX per week.

E.4

Principal exclusion criteria

Patients who meet any of the following criteria will not be eligible for the
study:
1. Current diagnosis of non-plaque forms of psoriasis, e.g.,
erythrodermic, guttate, or pustular psoriasis;
2. Known allergies or hypersensitivities that can have potential impact
on patient's participation as determined by the Investigator;
3. Receiving drugs that are known to exacerbate psoriasis such as beta
blockers, calcium channel blockers, antimalarial drugs or lithium;
4. Receiving oral or injectable (e.g., intraarticular, intramuscular, or
intravenous) corticosteroids for any other condition;
5. Women who are pregnant, lactating, or planning pregnancy while
enrolled in the study and at least 2 months after last dose of the IP; 6.
History of infection requiring hospitalization, parenteral antimicrobial
therapy, or
otherwise judged clinically significant by the Investigator within 1
month prior to first dose of IP;
7. History of infection requiring oral antimicrobial therapy within 2
weeks prior to first dose of IP;
8. Patients with active tuberculosis, prior history of unsuccessfully
treated tuberculosis (TB), latent TB (patients who are positive for test
for latent TB e.g. QuantiFERON®-TB Gold test or appropriate test), or
those who are at risk of developing TB;
9. History of any lymphoproliferative disorder (such as Epstein Barr
Virus [EBV] - related lymphoproliferative disorder), history of
lymphoma, leukemia, or signs and symptoms suggestive of current
lymphatic disease;
10. Patients suffering from significant acute or chronic, localized or
disseminated infections (bacterial/fungal/viral) or sepsis, or patients
with a history of recurring infections except Herpes simplex within 3
months prior to screening, or those who are at an increased risk of
developing infections or sepsis as determined by the Investigator;
11. History or presence of any immunological disease or use of
immunosuppressive or any therapy within a period that can have a 12. Recent live vaccine administration within 4 weeks prior to screening
and during the study;
13. Have any known condition affecting oral absorption of drug e.g.,
(malabsorption syndrome), or not able to swallow IP for any reason;
14. History of abuse of alcohol, recreational, or illegal drugs within 1
year prior to screening;
15. Tested seropositive for Hepatitis B [Hepatitis B surface antigen
(HBsAg)], and Hepatitis C virus (HCV), or human immunodeficiency virus
(HIV);
16. History of malignancy in the last five years prior to screening, except
curatively treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin;
17. Severe anemia (hemoglobin < 8 g/dL), leukopenia or thrombocytopenia (white blood cell [WBC] < 3,500/μL; platelet count < 100,000/μL), biochemistry (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3x upper limit of normal [ULN]; serum creatinine > 1.5 mg/dL (133 μmol/L) up to age 65 years and > ULN if age > 65 years) and serum bilirubin > 2 x ULN;
18. Significant abnormalities in the ECG;
19. Current or recent history of a severe, progressive, or uncontrolled
disease or any clinically significant laboratory abnormality, which in the
opinion of investigator makes the patient inappropriate for inclusion in
this study.
Additional Exclusion Criteria for MTX Add-on part:
1. Intolerance to MTX;
2. Contraindication to MTX (e.g., hypersensitivity to MTX or its
excipients, blood
dyscrasias etc.);
3. Receiving medicines with antifolate activity (e.g., co-trimoxazole).

E.5 End points

E.5.1

Primary end point(s)

The proportion of patients achieving at least 75% reduction (PASI 75) from baseline in Psoriasis Area and Severity Index (PASI) after 12 weeks of treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks from baseline

E.5.2

Secondary end point(s)

The proportion of patients achieving at least 75% reduction (PASI 75)
from baseline in PASI after 4 and 8 weeks of treatment;
• The proportion of patients achieving at least 50% reduction (PASI 50)
from baseline in PASI after 4, 8, and 12 weeks of treatment;
• The proportion of patients achieving at least 90% reduction (PASI 90)
from baseline in PASI after 4, 8, and 12 weeks of treatment;
• Improvement in Physician's Global Assessment (PGA) in psoriasis
severity scores from baseline at 4, 8, and 12 weeks of treatment.

E.5.2.1

Timepoint(s) of evaluation of this end point

4 and 8 weeks from baseline for PASI 75
4,8 and 12 weeks from baseline for PASI 50, PASI 90 and PGA

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

The study has 2 parts. Main part is randomised and MTX add on part is openlabel

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

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.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

2016-08-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-08-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-10-11

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