Clinical Trials Register

Summary
EudraCT Number:	2014-004467-20
Sponsor's Protocol Code Number:	AVXCLIN002
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:	2014-12-10
Trial 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

2014-004467-20

A.3

Full title of the trial

A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Dose-escalation, Single Centre Study to Assess the Safety and Efficacy of AVX001 when Administered Topically Once Daily in Patients with mild to moderate plaque psoriasis vulgaris in doses of 3% and 5% ointment

A.3.1

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

Et forsøg der er: randomiseret, dobbelt-blind, placebo-kontrolleret, sekventiel parallel gruppe, dosis-eskalering, enkelt center, for at vurdere sikkerhed og effekten af AVX001, når det påføres huden en gang daglig til patienter med mild til moderat plaque psoriasis vulgaris i doser på 3% og 5% salve

A.3.2

Name or abbreviated title of the trial where available

Avexxin (AVX001) 3% and 5% in plaque psoriasis - safety and efficacy study

A.4.1

Sponsor's protocol code number

AVXCLIN002

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	Avexxin AS
B.1.3.4	Country	Norway
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	Avexxin AS
B.4.2	Country	Norway
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	KLIFO A/S
B.5.2	Functional name of contact point	Joris Wilms
B.5.3	Address:
B.5.3.1	Street Address	Fruebjergvej 3
B.5.3.2	Town/ city	Copenhagen Ø
B.5.3.3	Post code	2100
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4539 17 99 41
B.5.5	Fax number	+4539 20 90 45
B.5.6	E-mail	jow@klifo.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	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	AVX001 ointment
D.3.2	Product code	AVX001
D.3.4	Pharmaceutical form	Ointment
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not assigned
D.3.9.2	Current sponsor code	AVX001
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2 to 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.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	Ointment
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Psoriasis vulgaris

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	18.0
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

To evaluate cutaneous tolerability of a newly formulated ointment containing AVX001 in the doses of 3% and 5% with a fall-back dose of 2% comparing to placebo, topically applied at symmetrically affected areas in patients with mild to moderate plaque psoriasis, in a four-week period, with two weeks follow up

E.2.2

Secondary objectives of the trial

• Evaluation of safety profile by recording of adverse events (AEs), clinical laboratory values, and vital signs;
• To assess efficacy as the impact on the modified Psoriasis Area and Severity Index – modified PASI
• Assessing the change in the severity of the disease using Physicians Global Assessment (PGA) score
• To assess the efficacy dose responses of AVX001
• To assess a possible systemic accumulation of the drug
• To assess Patient Reported Psoriasis-related Pruritus

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Stable plaque psoriasis vulgaris
2. Caucasian male patients aged 18 years or more
3. Plaque psoriasis present relatively symmetrically on arms and/or trunk, with disease severity of at least 1 of each of the signs erythema, infiltration and scaliness.
4. Furthermore, a test area within the area present with an index plaque minimum of 3 cm in diameter and with at least 2 of the signs erythema, infiltration and scaliness, in each side.
5. Following the receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out.

E.4

Principal exclusion criteria

1. Use of systemic anti-psoriatic agents (including Methotrexate and biological treatments, whether marketed or not) or drugs with a potential effect on plaque psoriasis within 1 month prior to randomisation.
2. Topical therapy with grade I-III glucocorticoids and/or calcipotriol on the targeted plaques within 1 month prior to randomisation
3. PUVA therapy within 28 days and UVB within 14 days prior to randomisation
4. Planned initiation of or changes in dose of concomitant medication that could affect plaque psoriasis during the study (e.g. beta-blockers, antimalarial drugs, lithium)
5. Known or suspected hypersensitivity to components in the investigational drug.
6. Previous exposure to AVX001
7. Current participation in another interventional clinical trial.
8. Significant concurrent, uncontrolled medical condition including, but not limited to, cardiac, infectious, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease as assessed by the investigator
9. Known or suspected hepatitis B or hepatitis C
10. Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening)
11. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency, psychological disorder or other conditions)

E.5 End points

E.5.1

Primary end point(s)

At end of follow-up period, the rate of patients having experienced local skin reaction adverse events (LSRAE) grade 3 and 4 throughout the study will be calculated at the individual doses and across all doses.

E.5.1.1

Timepoint(s) of evaluation of this end point

End of follow-up period

E.5.2

Secondary end point(s)

1. Ratio of patients experiencing at least 50% improvement of the modified PASI score at end of treatment.
2. Ratio of patients experiencing local skin reaction adverse events (LSRAE) grade 1 and 2
3. Change in PGA score

E.5.2.1

Timepoint(s) of evaluation of this end point

End of treatment or end of follow up

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

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

Systemic appearance/accumulation

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

Sequential parallel groups and parallel treatment in single subject

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

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

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

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

2014-12-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-11-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-06-04

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