Clinical Trials Register

Summary
EudraCT Number:	2018-001970-66
Sponsor's Protocol Code Number:	MC2-01-C7
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-11-23
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

Czechia - SUKL

A.2

EudraCT number

2018-001970-66

A.3

Full title of the trial

A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects with Mild-to-Moderate Psoriasis Vulgaris

Randomizované, multicentrické, s paralelními skupinami, pro zkoušejícího zaslepené klinické hodnocení k zhodnocení účinnosti a bezpečnosti krému MC2-01 v porovnání s vehikulem a aktivním srovnávacím léčivým přípravkem u pacientů s mírnou až středně závažnou lupénkou

A.3.1

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

Evaluation of the efficacy and safety of a new formulation (Cream) for the treatment of psoriasis vulgaris in adults as compared to a product already availible on the market and placebo.

A.4.1

Sponsor's protocol code number

MC2-01-C7

A.5.4

Other Identifiers

Name:

IND number

Number:

127152

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	MC2 Therapeutics Ltd.
B.1.3.4	Country	United Kingdom
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	MC2 Therapeutics Ltd.
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	proinnovera GmbH
B.5.2	Functional name of contact point	Cathrin Baum
B.5.3	Address:
B.5.3.1	Street Address	Wienburgstrasse 207
B.5.3.2	Town/ city	Muenster
B.5.3.3	Post code	48159
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49251270778148
B.5.5	Fax number	+492512707786148
B.5.6	E-mail	cathrin.baum@proinnovera.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	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	MC2-01 cream
D.3.4	Pharmaceutical form	Cream
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	Calcipotriol
D.3.9.1	CAS number	112965-21-6
D.3.9.3	Other descriptive name	CALCIPOTRIOL, ANHYDROUS
D.3.9.4	EV Substance Code	SUB22029
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	0.05
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Betamethasone dipropionate
D.3.9.1	CAS number	5593-20-4
D.3.9.3	Other descriptive name	BETAMETHASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00783MIG
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	0.64
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	Dovobet® Gel
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	United Kingdom
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	Dovobet 50 Mikrogramm/g + 0,5 mg/g Gel
D.3.4	Pharmaceutical form	Gel
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	Calcipotriol monohydrate
D.3.9.3	Other descriptive name	CALCIPOTRIOL MONOHYDRATE
D.3.9.4	EV Substance Code	SUB26081
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	0.052
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Betamethasone diproprionate
D.3.9.3	Other descriptive name	BETAMETHASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00783MIG
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	0.64
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	Cream
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

mild-to-moderate psoriasis vulgaris

E.1.1.1

Medical condition in easily understood language

Psoriasis is a long-lasting, non-infectious, autoimmune disease characterized by patches of abnormal skin, skaling, often itching, mostly with alternating episodes of disease activity and remission.

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

The primary objective is to evaluate the efficacy of MC2-01 cream compared to active comparator in subjects with psoriasis vulgaris.

E.2.2

Secondary objectives of the trial

The secondary objective is to characterise the safety profile of MC2-01 cream in subjects with psoriasis vulgaris.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have provided written informed consent.
2. Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening;
3. Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 15 g of trial medication per day.
4. Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs);
5. Have an mPASI score of at least 3;
6. Have a treatment area involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%;
7. Female subjects must be of either:
• Non-childbearing potential, i.e., post-menopausal for at least 1 year or have a confirmed clinical history of sterility (e.g., hysterectomy or tubal ligation) or,
• Childbearing potential with a negative urine pregnancy test prior to initiation of trial treatment, to rule out pregnancy.
8. Female subjects of childbearing potential must have a negative urine pregnancy test result at Screening, and if sexually active they must agree to use a highly effective method of contraception (i.e. a method with a failure rate of less than 1% per year when used consistently and correctly) for one month prior to Visit 1 and until the follow-up visit has been performed. Highly effective contraception is defined as follows:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
o oral
o intravaginal
o transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation:
o oral
o injectable
o implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system (IUS)
• bilateral tubal occlusion
• vasectomised partner (provided that is the sole sexual partner of the subject and that the vasectomised partner has received medical assessment of the surgical success.)
• sexual abstinence (if in line with the preferred and usual lifestyle of the subject and defined as refraining from heterosexual intercourse during the entire period of the trial. Periodic methods of abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not accepted methods of contraception.)

E.4

Principal exclusion criteria

1. Current diagnosis of unstable forms of psoriasis, including guttate, erythrodermic or pustular psoriasis;
2. Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis);
3. Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters;
4. Planned excessive or prolonged exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc;
5. History of hypersensitivity to any component of the test product or reference product;
6. Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders;
7. Females who are pregnant, breast feeding, or planning a pregnancy;
8. Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1/Baseline and during the trial:
• Etanercept – within 4 weeks prior to Visit 1/Baseline,
• Adalimumab, Alefacept, Infliximab – within 8 weeks prior to Visit 1/Baseline,
• Ustekinumab – within 16 weeks prior to Visit 1/Baseline,
• Other products – within 4 weeks/5 half-lives prior to Visit 1/Baseline (whichever was longer).

In general, patients who are candidates for biological or other systemic therapy are excluded from the trial.

9. Use of systemic treatments that suppress the immune system (fumaric acid, methotrexate, retinoids, PDE4 inhibitors, corticosteroids (excluding inhaled, nasal, auricular or ocular corticosteroids), ciclosporin (cyclosporine), and other systemic chemotherapeutic antineoplastic therapy) within 4 weeks prior to Visit 1/Baseline and during the trial;
10. Use of phototherapy (psoralen + ultraviolet A radiation [PUVA] and ultraviolet B radiation [UVB]) within 4 weeks prior to Visit 1/Baseline and during the trial;
11. Use of topical treatments (e.g., corticosteroids (Class 1, 2 and 3), vitamin D analogs, retinoids, PDE4 inhibitors, salicylic acid, pimecrolimus, tacrolimus, anthralin, tar), except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline. Glucocorticoids Class 4 (e.g. clobetasol propionate) are prohibited within 4 weeks prior to Visit 1/baseline. Subjects using glucocorticoids Class 4 may have their treatment switched to glucocorticoids Class 1-3. However, the treatment must be stopped at least 2 weeks prior to Visit 1/Baseline (refer to Appendix 3 Classification of Topical Corticosteroids).
12. Presence of infections in the treatment area (e.g. skin infection with bacteria (including tuberculosis), viruses, parasites or fungi) or skin manifestations of atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wound in the treatment area
13. Known Human Immunodeficiency Virus (HIV) infection
14. Have any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial;
15. Require the use of any concomitant medication that, in the investigator’s opinion, has the potential to cause an adverse effect when given with the investigational product (IP) or will interfere with the interpretation of the trial results;
16. Initiation of, or expected changes to, concomitant medication that may affect psoriasis (e.g., beta-blockers, chloroquines, lithium, and angiotensin converting enzyme [ACE] inhibitors);
17. Participation in another clinical trial or received an investigational product or non-marketed drug substances within 30 days prior to screening.
18. In the opinion of the investigator, the subject is unlikely to comply with the clinical trial protocol.

E.5 End points

E.5.1

Primary end point(s)

- Percentage change from Baseline in mPASI on the body (trunk and/or limbs) at Week 8

E.5.1.1

Timepoint(s) of evaluation of this end point

Screening (up to day -30)
day 0
weeks 1, 4, 6, 8

E.5.2

Secondary end point(s)

- PGA success
- Subject assessment of treatment convenience
- adverse events

E.5.2.1

Timepoint(s) of evaluation of this end point

- PGA success: week 8
- treatment convenience: week 8
- AEs: after treatment has finished

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

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)

Yes

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

Last visit last subject

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:

416

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

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

476

F.4.2.2

In the whole clinical trial

476

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 subjects have completed the trial, 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

2018-11-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-10-02

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