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    Summary
    EudraCT Number:2021-005382-40
    Sponsor's Protocol Code Number:DFD-29-CD-005
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-03-23
    Trial 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2021-005382-40
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of
    Rosacea Over 16 Weeks
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A new medication (capsules) for treatment of Rosacea (a type of skin inflammation)
    A.3.2Name or abbreviated title of the trial where available
    MVOR-2
    A.4.1Sponsor's protocol code numberDFD-29-CD-005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDr. Reddy's Laboratories Ltd.
    B.1.3.4CountryIndia
    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 supportDr. Reddy's Laboratories Ltd.
    B.4.2CountryIndia
    B.4.1Name of organisation providing supportJourney Medical Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Reddy's Laboratories Ltd
    B.5.2Functional name of contact pointMallikarjuna Rao
    B.5.3 Address:
    B.5.3.1Street AddressRoad No. 3, Banjara Hills, Hyderabad
    B.5.3.2Town/ cityTelangana
    B.5.3.3Post code500034
    B.5.3.4CountryIndia
    B.5.4Telephone number+914049002900
    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 nameDFD-29
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMINOCYCLINE HYDROCHLORIDE
    D.3.9.1CAS number 13614-98-7
    D.3.9.2Current sponsor codeDFD-29
    D.3.9.4EV Substance CodeSUB03304MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rosacea
    E.1.1.1Medical condition in easily understood language
    Rosacea is a common skin condition that causes blushing or flushing and visible blood vessels in the face. It may also produce small, pus-filled bumps.
    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 PT
    E.1.2Classification code 10039218
    E.1.2Term Rosacea
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the safety, efficacy, and tolerability of oral DFD-29 (Minocycline HCl), 40 mg compared to placebo in
    the treatment of papulopustular rosacea for 16 weeks
    E.2.2Secondary objectives of the trial
    Evaluation of the safety, efficacy, and tolerability of DFD-29 compared to
    Doxycycline capsules 40 mg (an authorized generic of Oracea® in the United States) in the treatment of papulopustular rosacea for 16 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
    2. Male and female subjects aged 18 years and above.
    3. Subjects must be in good general health as determined by the investigator and supported by the medical history.
    4. Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline.
    5. Subjects must have 15 to 60 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face at Baseline.
    6. Subjects must have not more than 2 nodules or cysts at Baseline.
    7. Subjects must agree to only use the study medication and to not use any other treatment for rosacea (prescription or over-the-counter [OTC]) during the course of the study.
    8. Subjects must be willing to minimize or not significantly change external factors that might trigger rosacea flare-ups (such as spicy food, thermally hot foods, soups and drinks, hot environments, prolonged sun exposure, strong winds, alcoholic beverages, etc.) throughout the study.
    9. Subjects must be free of any systemic or dermatologic disorder that, in the opinion of the investigator, will interfere with the study results, and especially free of any skin diseasesthat may confound the evaluation of rosacea.
    10. Females of childbearing potential must have a negative urine pregnancy test at the Screening and Baseline Visits. Sensitivity of such a test should at least be 25 mIU/mL or lower for human chorionic gonadotropin (hCG).
    11. Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of <1% up to 1 month after last dose.
    E.4Principal exclusion criteria
    1. Female subjects who are pregnant or nursing or planning to become pregnant during the study.
    2. Male subjects whose female partner is planning to conceive a child.
    3. Clinically significant abnormal laboratory test results that, in the opinion of the investigator, would compromise the subject's safety or ability to participate in the trial.
    4. History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
    5. History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
    6. Use of any firbidden treatment more recently than the indicated washout period prior to Baseline (Visit 2/Day 1).
    7. Need or intent to use any treatment listed in the protocol as prohibited during the current study.
    8. History of allergy or known sensitivity to minocycline, doxycycline, other tetracyclines, or any component of the study medication.
    9. Consumption of excessive alcohol, abuse of drugs, or a condition that could compromise and/or have drug or alcohol-addiction requiring treatment in the past 12 months.
    10. Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
    11. Use of any investigational drugs within 90 days prior to Baseline
    12. Participation in any other clinical study within 90 days prior to Baseline.
    13. Previous participation in this study.
    14. Subjects institutionalized due to legal or regulatory disorder
    15. Employees of the research center or Investigator.
    16. Family members of employees of the research center of Investigator
    E.5 End points
    E.5.1Primary end point(s)
    Safety/Tolerability.
    - Change from Baseline to each scheduled time point up to End of Study (EOS) for vital signs, physical examination and clinical laboratory tests.
    - Treatment-emergent AEs up to EOS.
    - Treatment-emergent AEs leading to premature discontinuation of study drug
    - Treatment-emergent SAEs up to EOS
    Primary Efficacy:
    Co-Primary Efficacy Endpoints
    1. Proportion of Subjects with IGA 'treatment success' grade 0 or 1 at week 16 with at least 2 grade reduction from Baseline to Week 16 compared to Placebo
    2. Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    Efficacy:
    1. Percentage Change in Total inflammatory lesion count (sum of papules, pustules, and nodules) from Baseline to Week 16 in the DFD-29 group compared to Placebo
    2. Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
    3. Total inflammatory lesion count reduction from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
    4. Proportion of subjects with at least 2-grade reduction in CEA score from Baseline to Week 16 in the DFD-29 group compared to Placebo.
    5. Change in DLQI score from Baseline to Week 16 in the DFD-29 group compared to
    Placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions 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.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    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.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 320
    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)
    Patients will receive standard of care after having finished the clinical trial
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-15
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