Clinical Trials Register

Summary
EudraCT Number:	2018-000097-30
Sponsor's Protocol Code Number:	2018-PSO-IL17R
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-02-28
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

Denmark - DHMA

A.2

EudraCT number

2018-000097-30

A.3

Full title of the trial

Efficacy of brodalumab in patients with psoriasis with failure of other anti-IL-17 treatments

Effekt af brodalumab hos patienter, som har haft svigt af anti-IL-17A-behandling

A.3.1

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

Efficacy of brodalumab in patients with psoriasis with failure of other anti-IL-17 treatments

Effekt af brodalumab hos patienter, som har haft svigt af anti-IL-17A-behandling

A.4.1

Sponsor's protocol code number

2018-PSO-IL17R

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	Herlev and Gentofte Hospital
B.1.3.4	Country	Denmark
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	LEO Pharma A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Herlev and Gentofte Hospital
B.5.2	Functional name of contact point	Dept of Dermatology and Allergy
B.5.3	Address:
B.5.3.1	Street Address	Kildegaardsvej 28
B.5.3.2	Town/ city	Hellerup
B.5.3.3	Post code	2900
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004538673204
B.5.5	Fax number	004538677615
B.5.6	E-mail	lone.skov.02@regionh.dk

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	Kyntheum
D.2.1.1.2	Name of the Marketing Authorisation holder	LEO Pharma A/S
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	brodalumab
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	BRODALUMAB
D.3.9.1	CAS number	1174395-19-7
D.3.9.3	Other descriptive name	Kyntheum
D.3.9.4	EV Substance Code	SUB180076
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	140
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)	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

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	10050576
E.1.2	Term	Psoriasis vulgaris
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

This study will evaluate brodalumab treatment in patients with moderate-to-severe psoriasis previously treated with anti-IL-17A with primary or secondary failure of treatment.

1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 3 months.
2. Percentage of patients achieving PASI90 after 3 months.

Formålet med studiet er at undersøge om patienter med moderat-til-svær psoriasis med tidligere svigt af anti-IL-17A har effekt af behandling med brodalumab.

• Undersøge andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 3 måneders behandling med brodalumab.
• Undersøge andelen af patienter der opnår PASI90 efter 3 måneders behandling med brodalumab.

E.2.2

Secondary objectives of the trial

1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 6 and 12 months respectively.
2. Percentage of patients achieving PASI90 after 6 and 12 month respectively.
3. Percentage of patients achieving PASI100 after 3, 6, and 12 months respectively.
4. Changes in DLQI score after 3, 6, and 12 months treatment with brodalumab compared to DLQI score before treatment with brodlaumab.
5. Changes in inflammatory cytokines in blood after treatment and at each evaluation point compared to before treatment.
6. Changes in oxidative stress level after treatment and at each evaluation point compared to before treatment.

• Undersøge andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 6 og 12 måneders behandling med brodalumab.
• Undersøge andelen af patienter der opnår PASI90 efter 6 og 12 måneders behandling med brodalumab.
• Undersøge andelen af patienter der opnår PASI100 efter 3, 6 og 12 måneders behandling med brodalumab.
• Ændring i DLQI score efter 3, 6 og 12 måneders behandling med brodalumab i forhold til DLQI score inden behandling med brodalumab.
• Ændring i inflammatoriske cytokiner i blodet efter behandling med brodalumab efter 4, 12, 26 og 52 uger i forhold til før behandlingen.
• Ændring i oxidativt stress niveau efter behandling med brodalumab efter 4, 12, 26 og 52 uger i forhold til før behandlingen.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients must be > 18
• Have had moderate-to-severe plaque psoriasis (PASI>10) and a PASI≥6 at screening.
• Be eligible to receive biological treatment
• Have been treated with anti-IL-17A (ixekizumab and/or secukinumab) with treatment failure, defined as either:
o Primary failure: <PASI50 after 3 months, or
o Secondary failure: Initial response, but with subsequent loss of efficacy
• Patients must have given their informed consent to the protocol and the clinical procedures
• Be able to speak and understand Danish
• No systemic or biological treatment for psoriasis in the last 4 weeks.
• No concomitant methotrexate treatment

1. Kvinder og mænd, som er mindst 18 år på screeningstidspunktet
2. Have haft moderat-til-svær psoriasis (PASI >10) og på screeningstidspunktet have PASI≥6
3. Være kandidater til biologisk behandling af deres psoriasis jf. medicinerrådets retningslinjer
4. Være behandlet med anti-IL-17A (secukinumab og/eller ixekizumab) for deres psoriasis og have fejlet på denne behandling, defineret som:
- Primær failure: <PASI50 efter 3 måneder, eller
- Sekundær failure: initial respons, men efterfølgende tab af effekt
5. Patienten skal være i stand til at kommunikere med forsøgslægen og opfylde de betingelser forsøget stiller samt afgive skriftligt samtykke, før forsøgsrelaterede procedurer kan påbegyndes.
6. Ikke have modtaget systemisk og/eller biologisk behandling for psoriasis de sidste 4 uger.
7. Der må ikke gives samtidig methotrexat

E.4

Principal exclusion criteria

• Patients with clinically significant disorders
• Patients with active TB/serious infections
• Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol. Patients with previous endogene depression.
• Pregnancy
• Nursing
• Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring or sterilization. Occlusive cap or condom with spermicidal cream is not considered safe contraception. Post-menopausal women (>12 months of amenorrhea) are allowed not to use contraception.
• Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study
• Allergy to brodalumab or any of the other ingredients in Kyntheum®
• Active Crohn’s disease
• Suicidal ideation and/or behavior

1. Patienter med alvorlige kendte sygdomme som cancer (undtagen almindelig hudkræft og celleforandringer på livmoderhalsen)
2. Patienter med kendt aktiv tuberkulose eller alvorlige infektiøse sygdomme
3. Planlagt levende vaccine under forsøget eller 6 uger før baseline
4. Gravide eller ammende kvinder
5. Fertile kvinder skal anvende sikker prævention i hele forsøgsperioden og op til 16 uger efter behandlingsstop med brodalumab. Sikker prævention er p-piller, spiral, depotindsprøjtning af gestagen, hormonstav indsat under huden, hormonal vaginalring, depotplaster. Pessar eller kondom med sæddræbende creme anses ikke som sikker prævention. Sterilitet eller overgangsalder (> 12 måneder med amenoré) fritages for krav om prævention
6. Patienter med aktiv Crohns sygdom
7. Allergi over for brodalumab eller andre af de aktive stoffer i Kyntheum®
8. Selvmordstanker og/eller -handlinger
9. Enhver psykiatrisk lidelse som i investigatorernes vurdering vil udelukke patienten fra at vedholde protokollen eller udføre studiet efter protokollen
10. Patienter med tidligere endogen depression

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 3 months.
2. Percentage of patients achieving PASI90 after 3 months.

• Andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 3 måneders behandling med brodalumab.
• Andelen af patienter der opnår PASI90 efter 3 måneders behandling med brodalumab.

E.5.1.1

Timepoint(s) of evaluation of this end point

1/7-20

E.5.2

Secondary end point(s)

Please see section E2

Se venligst sektion E2

E.5.2.1

Timepoint(s) of evaluation of this end point

1/7-20

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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)

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

Ingen

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

2018-03-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-04-20

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