Clinical Trials Register

Summary
EudraCT Number:	2019-003168-37
Sponsor's Protocol Code Number:	CAIN457ADE15
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-10-24
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

Germany - PEI

A.2

EudraCT number

2019-003168-37

A.3

Full title of the trial

A randomized, double-blind, multicenter, 24-week study of subcutaneous secukinumab to assess anti-interleukin-17A treatment in plaque psoriasis patients with coexisting non-alcoholic fatty liver disease (pINPOINt)

A.3.1

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

Study in patients with plaque psoriasis with coexisting non-alcoholic fatty liver disease

A.3.2

Name or abbreviated title of the trial where available

pINPOINt

A.4.1

Sponsor's protocol code number

CAIN457ADE15

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 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	Novartis Pharma 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	Novartis Pharma GmbH
B.5.2	Functional name of contact point	Medizinischer Infoservice
B.5.3	Address:
B.5.3.1	Street Address	Roonstr. 25
B.5.3.2	Town/ city	Nürnberg
B.5.3.3	Post code	90419
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4991127312100
B.5.5	Fax number	+4991127312160
B.5.6	E-mail	infoservice.novartis@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	Yes
D.2.1.1.1	Trade name	Cosentyx
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Secukinumab
D.3.2	Product code	AIN457
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	secukinumab
D.3.9.1	CAS number	1229022-83-6
D.3.9.2	Current sponsor code	AIN457
D.3.9.3	Other descriptive name	SECUKINUMAB
D.3.9.4	EV Substance Code	SUB33242
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	150
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.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	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

plaque psoriasis with coexisting non-alcoholic fatty liver disease

E.1.1.1

Medical condition in easily understood language

plaque psoriasis with coexisting non-alcoholic fatty liver disease

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

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	100000004858

E.1.2 Medical condition or disease under investigation

E.1.2	Version	22.0
E.1.2	Level	LLT
E.1.2	Classification code	10029530
E.1.2	Term	Non-alcoholic fatty liver
E.1.2	System Organ Class	100000004871

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 demonstrate superiority of secukinumab compared to placebo in patients with moderate to severe chronic plaque-type psoriasis and NAFLD with respect to PASI90 response at Week 12.

E.2.2

Secondary objectives of the trial

• To evaluate the effect of secukinumab compared to placebo on hepatic inflammation in patients with moderate to severe psoriasis and NAFLD with respect to serum ALT levels at Week 12.
• To evaluate the effect of secukinumab in patients with moderate to severe psoriasis and NAFLD compared to placebo on quality of life with respect to DLQI at Week 12.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study, and must provide written, signed and dated informed consent before any study assessment is performed.
2. Men and women ≥ 18 years of age at the time of consent.
3. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months prior to Screening with a PASI of >10 at baseline.
4. Candidate for systemic therapy, defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:
• topical treatment and/or,
• Phototherapy and/or,
• Previous systemic therapy.
5. Diagnosis of NAFLD by either ultrasound at Screening or liver histology within 6 months before Baseline.
6. Obesity with BMI > 25 kg/m2 at Screening.
7. Elevation of ALT 1.2 to 3.0 × ULN.
8. Liver fat ≥ 8% at Screening as determined by the reading of the central MRI vendor of locally produced images. Note: the MRI assessment should only be performed after eligibility has been confirmed for all other Screening assessments.

E.4

Principal exclusion criteria

1. Forms of psoriasis other than chronic plaque-type psoriasis at Screening.
2. Drug-induced psoriasis at Screening and baseline.
3. Ongoing use of prohibited treatments. Respective washout periods detailed in this section have to be adhered to.
4. History of hypersensitivity to any of the study drug constituents.
5. Pregnant or nursing (lactating) women.
6. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the study or longer if required by locally approved prescribing information.
7. Previous treatment with biological drug targeting IL-17 or the IL-17 receptor.
8. Past medical history record of infection with HIV, hepatitis B or hepatitis C prior to screening.
9. Active systemic infections during the last two weeks (exception: common cold) prior to randomization or any infection that reoccurs on a regular basis.
10. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold Plus (QFT) test at screening. Subjects with a positive or indeterminate QFT test may participate in the study if full tuberculosis work up (according to local practice/guidelines) was completed within 12 weeks prior to randomization and establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment according to local guidelines must have been completed prior to screening. During treatment of latent tuberculosis, ALT had to remain below 2x compared to pre-treatment ALT value.
11. Significant medical problems, including but not limited to:
• Congestive heart failure [New York Heart Association status of class III or IV].
• Severely reduced kidney function (eGFR ≤ 29 mL/min/1.73 m2).
12. Unstable weight (± 5%) over the last 6 months prior to Screening.
13. Type I diabetes, or uncontrolled Type II diabetes defined as HbAlc ≥ 10% at Screening.
14. Total white blood cell (WBC) count < 2500/μL, or neutrophils < 1500/μL or hemoglobin < 8.5 g/dL at Screening.
15. Evidence of hepatic decompensation or severe liver impairment or cirrhosis, as defined by the presence of any of the following abnormalities:
• Serum albumin < 3.2 mg/dL
• INR > 1.3
• Total bilirubin > 1.3 mg/dL
• AST > 5 × ULN
• Alkaline phosphatase > 300 IU/L
• Platelets outside of normal reference range (± 5%)
• History of esophageal varices, ascites, or hepatic encephalopathy
• Splenomegaly
16. History of liver transplantation or planned liver transplant.
17. History of biliary diversion.
18. Presence or history of other liver disease (including but not limited to autoimmune hepatitis, hereditary hemochromatosis, alpha 1-antitrypsin deficiency, Wilson’s disease, drug-induced liver disease).
19. Current, or history of, significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females or more than 30 g/day in males, on average) or a score on the modified AUDIT questionnaire ≥ 8.
20. History of bariatric surgery or intention to have bariatric surgery during study conduct.

Other protocol-defined exclusion criteria may apply.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients achieving PASI90 response at Week 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

E.5.2

Secondary end point(s)

• Serum ALT level at Week 12.
• Proportion of patients achieving DLQI 0/1 at Week 12.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 12

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

E.6.7

Pharmacodynamic

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

Yes

E.6.13.1

Other scope of the trial description

The aim of this study is to assess the therapeutic efficacy of secukinumab on the psoriatic skin and to explore the anti-inflammatory (reduction of hepatic inflammation and cell damage), anti-steatotic (reduction of hepatic triglyceride content) and anti-fibrotic (reduction of hepatic fibrosis) effects of secukinumab in patients with psoriasis and coexisting NAFLD.

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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

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)

None (subjects who have ended the participation in the Trial will be treated according to the physicians discretion)

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

2019-11-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-04

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-07-23

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