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    Summary
    EudraCT Number:2023-000463-32
    Sponsor's Protocol Code Number:CB-03-01/25
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2023-04-19
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2023-000463-32
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects with Facial Acne Vulgaris
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects with Facial Acne Vulgaris
    A.3.2Name or abbreviated title of the trial where available
    Not Available
    A.4.1Sponsor's protocol code numberCB-03-01/25
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02608450
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/076/2023
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCASSIOPEA SpA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCASSIOPEA SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCOSMO SpA
    B.5.2Functional name of contact pointCassiopea SpA
    B.5.3 Address:
    B.5.3.1Street AddressVia C. Colombo 1
    B.5.3.2Town/ cityLainate
    B.5.3.3Post code20045
    B.5.3.4CountryItaly
    B.5.4Telephone number+3902868 91124
    B.5.6E-maildermatology@cosmopharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecortexolone 17alpha-propionate
    D.3.2Product code CB-03-01
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClascoterone
    D.3.9.1CAS number 19068-29-8
    D.3.9.2Current sponsor codeCB-03-01
    D.3.9.3Other descriptive namecortexolone 17α-propionate
    D.3.9.4EV Substance CodeSUB201826
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Facial Acne Vulgaris
    E.1.1.1Medical condition in easily understood language
    Facial Acne
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000519
    E.1.2Term Acne vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal , surgically sterile, or using highly effective birth control methods. WOCBP must have a negative urine pregnancy test at the Screening/Baseline Visit.
    2. Subject has provided written and verbal 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.
    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.
    E.4Principal 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 evaluation of the test products or requires the use of interfering topical or systemic therapy.
    3. Subject has greater than two (2) facial nodules.
    4. Subject has nodulocystic acne.
    5. Subject has any condition which, in the investigator’s opinion, would make it unsafe for the subject to participate in this research study.
    6. Subject is currently enrolled in an investigational drug or device study.
    7. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
    8. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
    9. Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
    10. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
    11. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles (see Protocol Section 6.1).
    12. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
    13. Subject has used any of the following topical anti-acne preparations or procedures on the face:
    • Topical anti-acne treatments including, but not limited to, over-the-counter (OTC) acne cleansers or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two (2) weeks of the initiation of treatment.
    • Retinoids, including tazarotene, adapalene, tretinoin, within four (4) weeks of the initiation of treatment.
    • Light treatments, microdermabrasion, or chemical peels within eight (8) weeks of the initiation of treatment.
    14. Subject has used the following systemic anti-acne medications:
    • Corticosteroids (including intramuscular and intralesional injections) within four (4) weeks of the initiation of treatment. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four (4) weeks prior to the initiation of treatment).
    • Antibiotics within four (4) weeks of the initiation of treatment with the exception of five (5) days or less of antibiotic therapy during this period, BUT with no antibiotics use permitted within one (1) week prior to the initiation of treatment.
    • Spironolactone within eight (8) weeks of the initiation of treatment with the exception of five (5) days or less of spironolactone therapy during this period, BUT with no spironolactone use permitted within one (1) week prior to the initiation of treatment.
    • Retinoid therapy within six (6) months of the initiation of treatment.
    • Other systemic therapy which may materially affect the subject’s acne in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    • P1: Proportion of subjects in each treatment group achieving “success” at Week 12, with “success” defined as an IGA score of “clear (score=0)” or “almost clear (score=1)” AND at least a twopoint reduction in IGA compared to Baseline.
    • P2: Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
    • P3: Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • S1: Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
    • S2: Percent change from Baseline in total lesions counts in each treatment group at Week 12.
    • S3: Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
    • S4: Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    Georgia
    Ukraine
    E.8.7Trial has a data monitoring committee No
    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.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 316
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 16
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 300
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 392
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 708
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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