Clinical Trials Register

Summary
EudraCT Number:	2016-001204-39
Sponsor's Protocol Code Number:	MOB015B-III
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-03-01
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

UK - MHRA

A.2

EudraCT number

2016-001204-39

A.3

Full title of the trial

A multi-centre, randomized, two-armed, parallel group and evaluator-blinded study of efficacy and safety of topical MOB015B in the treatment of mild to moderate distal subungual onychomycosis (DSO)

A.3.1

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

A multi-centre, randomized, two-armed, parallel group and evaluator-blinded study of efficacy and safety of topical MOB015B in the treatment of mild to moderate distal subungual onychomycosis (DSO )

A.3.2

Name or abbreviated title of the trial where available

MOB015B-III

A.4.1

Sponsor's protocol code number

MOB015B-III

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	Moberg Pharma AB (publ)
B.1.3.4	Country	Sweden
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	Moberg Pharma AB (publ)
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Moberg Pharma AB (publ)
B.5.2	Functional name of contact point	Project Leader
B.5.3	Address:
B.5.3.1	Street Address	Gustavslundsvägen 42, 5tr
B.5.3.2	Town/ city	Bromma
B.5.3.3	Post code	16751
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+46852230711
B.5.5	Fax number	+4687352029
B.5.6	E-mail	christin.strid@mobergpharma.se

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	MOB015B
D.3.2	Product code	MOB015B
D.3.4	Pharmaceutical form	Cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Terbinafine-Hydrochloride
D.3.9.1	CAS number	78628-80-5
D.3.9.2	Current sponsor code	MOB015B
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	MICLAST®
D.2.1.1.2	Name of the Marketing Authorisation holder	Pierre Fabre Dermo-Kosmetik GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	MICLAST®
D.3.4	Pharmaceutical form	Medicated nail lacquer
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CICLOPIROX
D.3.9.1	CAS number	29342-05-0
D.3.9.4	EV Substance Code	SUB06245MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Distal Subungual Onychomycosis

E.1.1.1

Medical condition in easily understood language

Subungual Onychomycosis is a nail fungus

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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	10030338
E.1.2	Term	Onychomycosis
E.1.2	System Organ Class	10021881 - Infections and infestations

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 objective of this phase III study is to evaluate the efficacy of topical MOB015B in patients with mild to moderate DSO.

E.2.2

Secondary objectives of the trial

The secondary objective of this phase III study is to evaluate the safety of topical MOB015B in patients with mild to moderate DSO.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males or females 18 – 75 years of age (inclusive) at the time of Informed Consent
2. Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail
3. Positive culture for dermatophytes
4. Signed written informed consent (ICF) prior to any study-related activity

E.4

Principal exclusion criteria

1. Proximal subungual onychomycosis
2. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm)
3. Target toenail thickness more than 3 mm
4. ”Spike” of onychomycosis extending to eponychium of the target toenail
5. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
6. Other conditions than DSO known to cause abnormal nail appearance
7. Presence of toenail infection other than dermatophytes
8. Previous target toenail surgery with any residual disfigurement
9. Topical treatment of the nails with other antifungal medication or medical device within 6 weeks before Screening/Visit 1
10. Systemic use of antifungal treatment within 6 months before Screening / Visit 1
11. Severe moccasin tinea pedis
12. Signs of severe peripheral circulatory insufficiency
13. Uncontrolled diabetes mellitus (blood glucose not adjusted to stable levels despite antidiabetic therapy and / or careful medical monitoring by the family physician / specialist is not ensured)
14. Known immunodeficiency, i.e. congenital immunodeficiency, acquired immunodeficiency (e.g. HIV, some bone marrow diseases, extreme diets), iatrogenic by immunosuppressive drugs like cytostatics or by radiation therapy or immunomodulatory medications (e.g. TNF inhibitors)
15. Participation in another clinical trial with an investigational drug or device during the previous 3 months before Baseline/ Visit 2
16. Known allergy to any of the tested treatment products
17. A positive pregnancy test indicating pregnancy in a woman of childbearing potential* at Baseline/ Visit 2
18. Females who are pregnant or breastfeeding
19. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who:
• are of childbearing potential* and are not practicing an acceptable method of birth control**, or do not plan to continue practicing an acceptable method of birth control throughout the trial
20. Patients previously randomized in this study
21. History of, or current drug or alcohol abuse
22. Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the patient’s ability to completely understand the consequences of consent is missing
23. Close affiliation with the investigator (e.g. a close relative) or persons working at a study site, or patient who is an employee of the sponsor’s company
24. Patients who are institutionalized because of legal or regulatory order
25. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator

E.5 End points

E.5.1

Primary end point(s)

• Patients with complete cure at Week 52
Complete cure is defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical involvement of the target nail.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 52 of Treatment

E.5.2

Secondary end point(s)

• Complete cure (negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical disease involvement) of target nail at other time points than the primary endpoint (i.e., Visit 3, 4, 5, and 6)
• Mycological cure of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7)
• Negative fungal culture of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7)
• Negative direct KOH microscopy of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7)
• “Completely clear” or “almost clear” target nail (i.e., 0-10% clinical disease involvement of the target nail) during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7)
• Treatment success (defined as “completely clear” or “almost clear” and negative mycology) of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7)
• Patient´s subjective score of all treated nails except the little toenail(s) during the treatment period of the study (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7)
• Patient´s assessment of IMP handling (Visit 3)

E.5.2.1

Timepoint(s) of evaluation of this end point

• Complete Cure at other visits than Week 52 (i.e. Visits 3, 4, 5 and 6
• Mycological cure of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7)
• Negative fungal culture of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7)
• Negative direct KOH microscopy of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7)
•“Completely clear” or “almost clear” target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7)
• Treatment success (defined as “completely clear” or “almost clear” and negative mycology) of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7)
• Patient´s subjective score of all treated nails except the little toenail(s) at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7)
• Patient´s assessment of IMP handling (Visit 3)

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

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

Yes

E.8.1.4

Double blind

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)

Yes

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

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

End of Study will be determined as Last Visit Last Subject (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

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:

366

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

406

F.4.2.2

In the whole clinical trial

406

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)

Once a subject has completed their participation in the Study they will be treated as per Standard medical practice for this Patient Population.

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

2018-04-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-31

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-03-20

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