Clinical Trials Register

Summary
EudraCT Number:	2015-000762-65
Sponsor's Protocol Code Number:	CAIN457ADE01T
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-06-25
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

2015-000762-65

A.3

Full title of the trial

Single-arm study to assess a potential effect of anti-IL-17 (Secukinumab) in the treatment of pyoderma gangrenosum

A.3.1

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

Single-arm study to assess a potential effect of anti-IL-17 (Secukinumab) in the treatment of pyoderma gangrenosu

A.4.1

Sponsor's protocol code number

CAIN457ADE01T

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	Technische Universität München, School of Medicine, represented by Dean
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Pharmaceuticals 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	Department of Dermatology and Allergy Technische Universität München
B.5.2	Functional name of contact point	Studienzentrum Dermatologie
B.5.3	Address:
B.5.3.1	Street Address	Biedersteinerstr. 29
B.5.3.2	Town/ city	Munich
B.5.3.3	Post code	80802
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49894140 3579
B.5.5	Fax number	+49894140 3452
B.5.6	E-mail	kilian.eyerich@tum.de

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 GmbH
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	Cosentyx
D.3.2	Product code	EU/1/14/980/002; EU/1/14/980/003
D.3.4	Pharmaceutical form	Solution and suspension for suspension 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.3.11 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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pyoderma gangrenosum is an autoinflammatory disease, characterized by relapsing, painful ulcers of the skin. Treatment of PG is difficult. Patients suffer from long hospitalization, pain and reduced life quality. New therapeutic strategies are needed. Immunohistological staining show a high amount of IL-17 in PG. IL-17+ immune cells were located in proximity to cellular damage, indicating an involvement in the pathogenesis. Targeting IL-17 with neutralizing IL-17 antibodies seems promising.

E.1.1.1

Medical condition in easily understood language

Pyoderma gangrenosum is an autoinflammatory disease. It is difficut to treat. Treatment with a new drug against IL17 seems promising.

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	10037635
E.1.2	Term	Pyoderma gangrenosum
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue 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 evaluate efficacy and tolerability of secukinumab in patients with pyoderma gangrenosum after 16 week treatment with 300 mg s.c. secukinumab.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Confirmed diagnosis of pyoderma gangrenosum, biopsy-proven, non-healing ulcer with primarily neutrophil infiltration, regardless of size and location, characterization of target lesion (size, PGA, duration, age 18-75 years of age, body weight ≥ 40 kg and ≤ 160 kg, signed informed consent from patient, the first two patients of the trial must have received one other treatment for pyoderma gangrenosum before being included.

E.4

Principal exclusion criteria

Permanent severe diseases, especially those affecting the immune system, pregnancy or breast feeding, history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia, myocardial infarction or cardiac arrhythmia which requires drug therapy, evidence of severe renal dysfunction or significant hepatic disease, history of irritable bowel disease, history of lymphoproliferative disorders, simultaneous participation in another clinical trial or participation in another clinical trial during the last 6 months.

E.5 End points

E.5.1

Primary end point(s)

Change of the Physician's global assessment (Grade 0-4) of the target lesion

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

E.5.2

Secondary end point(s)

a) Change in surface area of lesions of pyoderma gangrenosum
b) Laboratory measurements
c) Patient's quality of life (measured by "dermatology life quality index, DLQI")
d) Immunohistochemical analysis of IL-17+ immune cells
e) Change of the Physician's global assessment (Grade 0-4) of the target lesion

E.5.2.1

Timepoint(s) of evaluation of this end point

a) Week 2, 4, 8, 16, 28, 32, 40
b) Week 2, 4, 8, 16, 28, 32, 40
c) Week 2, 4, 8, 16, 28, 32, 40
d) Week 16 as compared to week 0
e) Week 32

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

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

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

Yes

E.8.4

The trial involves multiple sites in the 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

Last patient, last visit.

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)

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.4.2.2

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)

Further treatment is offered by the Clinic of dermatology and allergy of the Technische Universität München independently of participation, study results or adverse events. According to the disease activity control visits every 2 – 4 months are recommended in the specialized outpatient clinic for inflammatory and autoimmune diseases. Attendance or non-attendance is free decision by the patients.

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

2015-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-01

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-09-19

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