Clinical Trials Register

Summary
EudraCT Number:	2015-002637-21
Sponsor's Protocol Code Number:	CB-03-01/27
National Competent Authority:	Bulgarian Drug Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-04-18
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

Bulgarian Drug Agency

A.2

EudraCT number

2015-002637-21

A.3

Full title of the trial

An Open-Label, Long-Term Extension Study to Evaluate the Safety of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice-Daily in Subjects with Acne Vulgaris

Отворено, дългосрочно разширено проучване за оценка на безопасността на Cortexolone 17α-Propionate (CB-03-01) 1% крем, прилаган два пъти дневно при пациенти с акне вулгарис

A.3.1

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

Extension study to evaluate the Safety of CB-03-01 1% cream applied twice daily in subjects with Acne Vulgaris

A.3.2

Name or abbreviated title of the trial where available

not available

A.4.1

Sponsor's protocol code number

CB-03-01/27

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	CASSIOPEA SpA
B.1.3.4	Country	Italy
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	CASSIOPEA SpA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CASSIOPEA SpA
B.5.2	Functional name of contact point	Cassiopea Research & Development
B.5.3	Address:
B.5.3.1	Street Address	Via C. Colombo 1
B.5.3.2	Town/ city	Lainate
B.5.3.3	Post code	20020
B.5.3.4	Country	Italy
B.5.4	Telephone number	+3902868 91 124
B.5.5	Fax number	+3902933 37 663
B.5.6	E-mail	R&D@cassiopea.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	cortexolone 17alpha-propionate
D.3.2	Product code	CB-03-01
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	17α‐propionate 21‐dihydroxypregn‐4‐ene‐3, 20‐dione
D.3.9.1	CAS number	19608‐29‐8
D.3.9.2	Current sponsor code	CB-03-01
D.3.9.3	Other descriptive name	cortexolone 17α‐propionate
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

Facial and truncal acne vulgaris

E.1.1.1

Medical condition in easily understood language

Facial and truncal acne vulgaris

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	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10000519
E.1.2	Term	Acne 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 of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in subjects with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.

Основната цел на това проучване е да се определи дългосрочната безопасност на крем CB-03-01, 1%, прилаган два пъти дневно за допълнителни девет месеца при пациенти с акне вулгарис, които са участвали в основните проучвания от фаза 3 за общ период на лечение до 12 месеца.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject must have been enrolled in one of the Phase 3 pivotal studies (CB-03-01/25 and CB-03-01/26), completed the assigned
treatment regimen without any material non-compliance with study requirements or test article dosing (compliance ≥80%), and
completed the final study visit (Visit 4-Pivotal).
2. Subject agrees to treat his/her facial acne and truncal acne (if designated by investigator AND desired by subject) during the
nine month study period per protocol. Note: Subjects who are clear (IGA=0) at Visit 4-Pivotal are also eligible for this study.
3. Females must be post-menopausal1, surgically sterile2, or using highly effective birth control methods.3,4 Women of
childbearing potential (WOCBP)5 must have a negative urine pregnancy test (UPT) at Visit 4-LTF (or Visit 4-Pivotal, if the visits
occur on the same day).
4. Subject has provided written informed consent/assent. A subject under 18 years of age must provide written informed assent
and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must
provide informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written
informed consent at that time to continue study participation.
5. Subject is willing to comply with study instructions and return to the clinic for required visits.
during the study, the subject must provide written informed consent at
that time to continue study participation.
3. Subject has an Investigator’s Global Assessment (IGA) score of 3 or 4 [0
(clear) to 4 (severe) scale].
4. Subject has facial acne vulgaris, which can include the nose, with at least
30 to a maximum of 75 inflammatory lesions (papules, pustules, and
nodules) and 30 to a maximum of 100 non-inflammatory lesions (open
and closed comedones).
5. Subject and parent/guardian (if applicable) are willing to comply with
study instructions and return to the clinic for required visits.
6. Subject has used the same type and brand of make-up, other facial
products (exclusive of RX/OTC acne cleansers) and hair products (e.g.,
shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to
the Baseline Visit and agrees to continue his/her other general skin and
hair care products and regimen for the entire study.

Пациентите трябва да са били включени за участие в едно от основните проучвания от фаза 3 (CB-03-01/25 и CB-03-01/26), да са завършили назначения режим на лечение без никакви съществени нарушения на изискванията на проучването или дозирането на изпитвания продукт (спазване на правилата ≥80%) и да са направили последното посещение по проучването (Посещение 4-основно проучване).
2. Пациентът се съгласява да лекува своето акне по лицето и акне по тялото (ако е определено от изследователя и желано от пациента) по време на деветмесечния период на проучването съгласно протокола. Забележка: Пациентите, при които се наблюдава изчистване (ООИ=0) при Посещение 4-основно проучване, също отговарят на критериите за участие в това проучване.
3. Жените трябва да бъдат след менопауза1, да бъдат хирургически стерилни2 или да използват високоефективни методи за контрол на раждаемостта.3,4 Жените с детероден потенциал (ЖДП)5 трябва да имат отрицателен резултат на уринен тест за бременност при Посещение 4-LTF (или Посещение 4-основно проучване, ако посещенията се извършват в един и същ ден).
4. Пациентът е дал писмено информирано съгласие/одобрение. Пациентите под 18-годишна възраст трябва да представят писмено информирано съгласие и да бъдат придружени от родител или настойник по време на подписването на формуляра за одобрението/съгласието. Родителят или настойникът на пациента също трябва да даде своето информирано съгласие. Ако пациентът навършва 18 години по време на проучването, той трябва да подпише декларация за информирано съгласие към този момент, за да продължи участието си в проучването.
5. Пациентът е склонен да спазва инструкциите по проучването и да посещава клиниката за задължителните посещения.

E.4

Principal exclusion criteria

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. Subject has any skin pathology or condition that could interfere with the safety evaluation of the test products or requires the
use of interfering topical or systemic therapy (see Section 8.1: Prohibited Medications and Therapies).
3. Subject has any condition which, in the investigator’s opinion, would make it unsafe or unsuitable for the subject to participate
in this research study.
4. Subject plans to use any other investigational drug or device during participation in this study.
5. Subject, and parent/guardian if required, is unable to communicate or cooperate with the investigator due to language
problems, poor mental development, or impaired cerebral function.
6. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subject who
is unable to return for scheduled follow-up visits.
7. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test article.
8. Subject is or plans to use any topical anti-acne preparations (excluding CB-03-01 cream) or procedures on the face (or trunk, if
applicable) or any systemic anti-acne medications (as detailed in Section 8.1: Prohibited Medications and Therapies) during the
study.

Пациентът е жена, която е бременна, кърми или планира да забременее по време на проучването.
2. Пациентът има кожна патология или състояние, което може да повлияе на оценката на безопасността на изпитваните продукти или изисква използването на локална или системна терапия (вижте раздел 8.1: Забранени лекарства и терапии).
3. Състоянието на пациента е такова, че по мнението на изследователя, за него няма да е безопасно или подходящо да участва в това изследване.
4. Пациентът планира да използва някакво друго изпитвано лекарство или устройство по време на участието си в това проучване.
5. Пациентът, и родителят/настойникът ако се изисква, не е в състояние да общува или сътрудничи на изследователя поради езикови проблеми, слабо психическо развитие или нарушена мозъчна функция.
6. Пациентът може да е ненадежден за целите на проучването, включително лица, употребяващи прекомерни количества алкохол или злоупотребяващи с наркотици, или пациенти, които не могат да се върнат за планираните посещения за проследяване.
7. Пациентът има известна свръхчувствителност или предишни алергични реакции към някой от активните или неактивните компоненти на изпитвания продукт.
8. Пациентът използва или планира да използва някакви локални препарати против акне (с изключение на крем CB-03-01) или процедури върху лицето (или тялото, ако е приложимо) или някакви системни лекарства против акне (както е описано в раздел 8.1: Забранени лекарства и терапии) по време на проучването.

E.5 End points

E.5.1

Primary end point(s)

•Incidence of any local and systemic treatment emergent AEs (TEAEs).
•Number of subjects with presence (and severity) of each individual LSR (Local Skin Reaction) (telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus) for each treatment area, as applicable, at each time point collected (Baseline, and LTF-Months 1, 3, 6, and 9, and any Unscheduled Visits).
•UPT results in all WOCBP at Baseline, LTF-Month 6, and EOS.

- Честота на поява на някакви НР, породени от локално и системно лечение (НРПЛ).
 - Брой на пациентите с наличие (и тежка форма) на всяка индивидуална ЛКР (телеангиектазии, атрофия на кожата, червени стрии, зачервяване, оток, лющене/сухота, щипене/парене и сърбеж) за всяка третирана област, когато е приложимо, при всяка записана времева точка (изходно ниво и LTF-месеци 1, 3, 6 и 9 и всички непланирани посещения).
- Резултати от УТБ за всички ЖДП при изходното ниво, LTF-месец 6 и КП.

E.5.1.1

Timepoint(s) of evaluation of this end point

during the study

E.5.2

Secondary end point(s)

• Number of subjects with each IGA (Investigator’s Global Assessment, IGA) severity score for each treatment area, as applicable, at each time point collected

- Брой на пациентите с резултата за тежестта на симптомите за всяка ООИ за всяка третирана област, когато е приложимо, във всяка записана времева точка

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline and LTF-Months 1, 3, 6, and 9

изходно ниво и LTF-месеци 1, 3, 6 и 9

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

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Serbia

United States

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

ПППУ

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

Yes

F.1.1

Number of subjects for this age range:

359

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

309

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

240

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

300

F.4.2.2

In the whole clinical trial

600

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

2016-06-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-08-03

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IMP with orphan designation in the indication
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