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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2023-000462-33
    Sponsor's Protocol Code Number:171-7151-202
    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 number2023-000462-33
    A.3Full title of the trial
    An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects with Acne Vulgaris
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
    A.3.2Name or abbreviated title of the trial where available
    Not Available
    A.4.1Sponsor's protocol code number171-7151-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01831960
    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 SponsorIntrepid Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportCosmo 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
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to determine a) the adrenal suppression potential and b) the pharmacokinetic (PK) properties of CB-03-01 Cream, 1% in subjects with 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 female 12 years of age or older at the time of consent.
    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 the next study visit to continue study participation.
    3. Females must be post-menopausal, surgically sterile or using highly effective birth control methods with a negative urine pregnancy test at the Screening and Baseline Visits.
    4. Subject has moderate to severe facial acne vulgaris (Grade 3 to 4) as determined by the Investigator’s Global Assessment (IGA) [0 (clear) to 4 (severe) scale] and obvious acne on the chest and/or back at the Screening Visit.
    5. Subject has facial acne vulgaris (including the nose) with a minimum of 20 inflammatory lesions (papules, pustules, and nodules/cysts) and a minimum of 20 non-inflammatory lesions (open and closed comedones) at the Screening Visit.
    6. Subject must be in general good health in the opinion of the investigator, with normal renal function as defined per protocol, based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, and clinical laboratory values (hematology, serum chemistry and urinalysis).
    7. Subject has normal response to cosyntropin stimulation defined as a Screening CST with a 30-minute post-stimulation cortisol level of > 18 μg/dL.
    8. Subject is able to communicate with the staff and is willing to comply with study instructions, reside at and/or return to the clinic for required visits.
    E.4Principal exclusion criteria
    1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
    2. Subject is 12- to < 18 years of age and has a Body Mass Index (BMI) for age percentile > 95%.
    3. Subject is > 18 years of age and has a BMI > 32.0 kg/m2.
    4. Subject reported use of tobacco, smoking cessation products, or products containing nicotine within three (3) months prior to Screening.
    5. Except for the use of contraceptives, subject reported use of any prescription drug or herbal product within 14 days prior to dosing, any non- prescription drug or vitamin or mineral supplements within 7 days prior to dosing; any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme inducers such as paint solvents or pesticides within 30 days of Baseline.
    6. Subject has used topical anti-acne medications containing retinoids such as tazarotene, adapalene, tretinoin, within four (4) weeks of Baseline.
    7. Subject has used the following systemic anti-acne medications: antibiotics within two (2) weeks of Baseline, spironolactone within four (4) weeks of Baseline, or retinoid therapy within three (3) months of Baseline.
    8. Subject has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.
    9. Subject has any condition which, in the investigator’s opinion, would make it unsafe for the subject to participate in this research study.
    10. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
    11. Subject has used light treatments, microdermabrasion or chemical peels to the face, chest and back within eight (8) weeks of Visit 2 (Baseline).
    12. Subject cannot avoid any type of strenuous exercise (swimming, running, team sports, etc.,) or the use of hot tubs/saunas from Visit 2 (Baseline) to the end of the study (Visit 5).
    13. Subject has any clinically significant medical abnormality or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. This includes conditions (e.g., gastrointestinal surgery) that may interfere with metabolism, or excretion.
    14. Subject has a history of alcohol and/or drug abuse in the investigator's judgment or has a positive urine drug screen result at the Screening Visit.
    15. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
    16. Subject is known to be hypersensitive to the test article or any components in the test article.
    17. Subject has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline).
    18. Subject is currently enrolled in an investigational drug or device study.
    19. Subject has used topical corticosteroids (including inhaled and intranasal corticosteroids) within two weeks of the Cosyntropin Stimulation Test (CST) at the Screening Visit and/or between the Screening CST and Baseline.
    20. Subject has used systemic corticosteroids (including intramuscular and intralesional injections) within four (4) weeks of the CST at the Screening Visit and/or between the Screening CST and Baseline.
    21. Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit physiological diurnal variation).
    22. Subject has experienced significant blood loss within 60 days or has donated plasma within 72 hours prior to Visit 2 (Baseline).
    23. Subject tests positive at screening for human immunodeficiency virus (HIV) or is known to be seropositive for HIV.
    24. Subject tests positive at Screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.
    25. Subject had major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study.
    26. Subject has participated in a previous CB-03-01 study.
    E.5 End points
    E.5.1Primary end point(s)
    • HPA Axis Response to Cosyntropin - Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with Cosyntropin (CST) at Screening, and Day 14 (or EOS). HPA axis suppression is defined as a post-stimulation serum cortisol level < 18 μg/dL at Day 14 (or EOS).
    • Concentration-time profiles of cortexolone 17α-propionate and cortexolone in plasma after a) first dose and b) after the last dose on Day 14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    • Clinical laboratory testing (hematology, clinical chemistry, and urinalysis) at Screening and Day 14 (or EOS).
    • Local and systemic adverse events – every visit (Baseline, Days 5, 10 and 14).
    • The presence (and severity) of the following local skin reactions: telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning and pruritus will be documented at Baseline, Days 5, 10 and 14.
    • Physical examination/vital signs at Screening and Day 14 (or EOS).
    • Urine pregnancy testing in all women who are not post-menopausal or surgically sterile at Screening, Baseline, and Day 14.
    • ECG at Screening and end of study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    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 months6
    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: 22
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 42
    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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