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    Summary
    EudraCT Number:2015-002052-27
    Sponsor's Protocol Code Number:DRM04-HH04
    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:2015-08-14
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2015-002052-27
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED EFFICACY AND SAFETY STUDY OF DRM04 IN SUBJECTS WITH AXILLARY HYPERHIDROSIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate if DRM04 is safe and effective in patients with axillary hyperhidrosis.
    A.4.1Sponsor's protocol code numberDRM04-HH04
    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 SponsorDermira, 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 supportDermira, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDermira, Inc.
    B.5.2Functional name of contact pointSenior Director, Clinical Operation
    B.5.3 Address:
    B.5.3.1Street Address275 Middlefield Road
    B.5.3.2Town/ cityMenlo Park, Suite 150
    B.5.3.3Post code CA 94025
    B.5.3.4CountryUnited States
    B.5.4Telephone number001650421-7484
    B.5.5Fax number001650365-3410
    B.5.6E-maillynne.deans@dermira.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 nameDRM04 Topical Wipes
    D.3.2Product code DRM04
    D.3.4Pharmaceutical form Cutaneous solution
    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 INNGLYCOPYRRONIUM
    D.3.9.1CAS number 1449568-31-3
    D.3.9.2Current sponsor codeDRM04
    D.3.9.3Other descriptive nameGlycopyrronium tosylate monohydrate; Glycopyrronium tosylate hydrate; Glycopyrronium tosylate
    D.3.9.4EV Substance CodeSUB02381MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    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 placeboCutaneous solution
    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
    Primary axillary hyperhidrosis
    E.1.1.1Medical condition in easily understood language
    Extreme underarm sweating without an obvious cause.
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10020642
    E.1.2Term Hyperhidrosis
    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
    The objective of this study will be to assess the efficacy and safety of DRM04 Topical Wipes, 3.75% compared to vehicle when applied once daily for 28 days in subjects with primary axillary hyperhidrosis.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent.
    2. Age ≥18 years.
    3. Willing to comply with the protocol.
    4. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.
    5. Primary, axillary hyperhidrosis of at least 6 months duration.
    6. HDSS of 3 or 4 at Baseline.
    7. Average ASDD item #2 score of ≥4 at Baseline. Subjects must at a minimum complete 4-7 days of the ASDD within 7 days of randomization.
    8. Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically. Subjects with a measurement of <50 mg/each axilla/5 minutes who, in the opinion of the Investigator, have a diagnosis of hyperhidrosis, may have gravimetric measurements performed up to a total of 3 times within the 35 days prior to randomization.
    9. If female and of childbearing potential, subject must be willing to use an accepted method of birth control during study participation and for 30 days after the last study drug application. Females are considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), have been diagnosed as infertile, have same gender sex partner, or are postmenopausal for at least 1 year.
    Acceptable methods of birth control include: abstinence, oral contraceptives, contraceptive patches/implants; injectable contaceptives. Birth control method must have been stable/unchanged for 12 weeks prior to Baseline and must remain unchanged during study participation.
    10. If male, is vasectomized or agrees to use an accepted method of birth control with female partner during study participation and for 30 days after the last study drug application. Male subjects must agree not to donate sperm.
    E.4Principal exclusion criteria
    1. Current pregnancy or lactation.
    2. Prior surgical procedure for hyperhidrosis.
    3. Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational), such as miraDry®.
    4. Prior treatment with axillary iontophoresis within 4 weeks of Baseline.
    5. Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
    6. Subject who are actively participating in an experimental therapy study or who received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline Visit.
    7. Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.
    8. Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.
    9. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
    10. Abnormal findings on screening ECG deemed clinically significant by the Investigator.
    11. Treatment with psychotherapeutic medications (including benzodiazepines or selective serotonin reuptake inhibitors [SSRIs]). Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.
    12. Treatment with medications having systemic anticholinergic activity, centrally acting alpha-2 adrenergic agonists (e.g. clonidine, guanabenz, methyl dopa), or beta-blockers within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months prior to Baseline and is not expected to change over the course of the study (inhaled anti-cholinergic drugs or beta agonists are allowed).
    13. Intravenous (IV), oral glycopyrrolate treatment or any treatment with atropine, belladonna, scopolamine, clindinium or hyoscyamine within 4 weeks prior to Baseline.
    14. Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
    15. Known history of Sjögren’s syndrome or Sicca syndrome.
    16. History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.
    17. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
    18. History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia with a ventricular rate greater than 100 (other than sinus tachycardia).
    19. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.
    20. Close affiliation with the investigator (e.g. a close relative) or persons working at the trial sites or subject who is an employee of the Sponsor’s company.
    21. Subjects who are institutionalized because of legal or regulatory order.
    E.5 End points
    E.5.1Primary end point(s)
    - Mean absolute change from baseline in gravimetrically-measured sweat production at Week 4.
    - Proportion of subjects who have a ≥4-point improvement in the weekly mean score of ASDD item #2 from
    baseline at Week 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will both be measured at week 4 in comparisation to baseline.
    E.5.2Secondary end point(s)
    - Proportion of subjects who have a ≥2 grade improvement in HDSS from baseline at Week 4
    - Proportion of subjects who have at least a 50% reduction in gravimetrically measured sweat production from baseline at Week 4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Will both be measured at week 4 in comparisation to baseline.
    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 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 No
    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 years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 330
    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)
    After treatment periode for this trial the patients can roll over in an open label long term safety study. If patient is not willing to roll over he will receive standart approved treatment of that condition from his doctor.
    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 Decision2015-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-24
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