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    Summary
    EudraCT Number:2022-000922-46
    Sponsor's Protocol Code Number:GPBK-08/2018
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2023-01-23
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-000922-46
    A.3Full title of the trial
    An Open-Label, Uncontrolled, Multicenter Study to Evaluate the Safety, Local Tolerability, Systemic Exposure, and Efficacy of 1% GPB Cream in Adolescents With Severe Primary Axillary Hyperhidrosis
    PIP decision number updates: P/0565/2021; P/0467/2022
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label study to evaluate the safety, local tolerability, systemic exposure, and efficacy of 1% GPB cream in adolescents with severe primary axillary hyperhidrosis
    A.4.1Sponsor's protocol code numberGPBK-08/2018
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/420/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDr. August Wolff GmbH & Co. KG Arzneimittel
    B.1.3.4CountryGermany
    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. August Wolff GmbH & Co. KG Arzneimittel
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. August Wolff GmbH & Co. KG Arzneimittel
    B.5.2Functional name of contact pointHead of Clinical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressSudbrackstraße 56
    B.5.3.2Town/ cityBielefeld
    B.5.3.3Post code33611
    B.5.3.4CountryGermany
    B.5.4Telephone number+495218808319
    B.5.5Fax number+495218808474
    B.5.6E-mailclarissa.masur@drwolffgroup.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 Yes
    D.2.1.1.1Trade name Axhidrox 2.2 mg/pump actuation cream
    D.2.1.1.2Name of the Marketing Authorisation holderDr. August Wolff GmbH & Co. KG Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 name1% GPB cream
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlycopyrronium Bromide
    D.3.9.1CAS number 51186-83-5
    D.3.9.4EV Substance CodeSUB07951MIG
    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
    Severe primary axillary hyperhidrosis
    E.1.1.1Medical condition in easily understood language
    Primary axillary hyperhidrosis is a dysregulation of the autonomous nerve system resulting in excessive sweating as a result of overstimulation of the eccrine sweat glands.
    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 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 evaluation of the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.
    E.2.2Secondary objectives of the trial
    Key secondary objective:
    The evaluation of the efficacy of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Medical diagnosis of severe primary axillary hyperhidrosis with symptoms for at least 3 months before Screening and with a PRHS score of ≥5 at Screening 2 and Day 1
    2. At least 50 mg of sweat production in each axilla measured gravimetrically over a period of 5 minutes at room temperature along with a humidity consistent with the normal climate in that area (patients have to acclimatize to that room for at least 30 minutes before the measurement) at Screening 2
    3. Adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile ≥10 and ≤90
    4. Local tolerability assessment (skin reaction) score = 0
    5. Patient and legal guardians are willing and able to comply with protocol requirements, including blood sample collection
    6. Patient and legal guardians are capable of understanding the nature, significance, and implications of the clinical study and to form a rational intention in the light of the facts, voluntarily agree to participation and the study’s provisions, and legal guardians have duly signed the informed consent form
    E.4Principal exclusion criteria
    Hyperhidrosis-related exclusion criteria:
    1. Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases (such as but not limited to hyperthyroidism, lymphoma, and malaria) or secondary to the use of medication (such as but not limited to antidepressants or sympathomimetics)
    2. Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment
    3. Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months

    Medical history and concomitant disease exclusion criteria:
    4. Hypersensitivity to glycopyrronium and its salts (such as glycopyrronium bromide), or to any of the excipients of the investigational medicinal product (IMP)
    5. Corrected QT (QTc) >450 msec, or QTc ≥480 msec in patients with bundle branch block
    6. Aspartate aminotransferase and alanine aminotransferase ≥2 x upper limit of normal (ULN), alkaline phosphatase and bilirubin >1.5 x ULN at Screening (free bilirubin >1.5 × ULN is acceptable if bilirubin fraction test result of direct bilirubin <35% is available)
    7. Hashimoto’s disease
    8. Active or past neuromuscular disease
    9. Glaucoma
    10. Active or past acute bleeding with unstable heart and blood circulation status
    11. Active chronic inflammatory disease of the large bowel (severe ulcerative colitis)
    12. Active or past chronic inflammation of the large bowel complicated by severe extension of the colon (toxic megacolon complicating ulcerative colitis)
    13. Active or past blockage of the bowel as a result of paralysis of the bowel muscles (paralytic ileus)
    14. Myasthenia gravis
    15. Sjögren syndrome
    16. Dermal disorders (ie, infections, irritations, or inflammation) in one or both axilla(e)
    17. Significant cardiovascular disease
    18. Thyrotoxicosis
    19. Active or past difficulty in passing urine (successfully treated phimosis is acceptable for study participation)
    20. Significant cardiac arrhythmia, such as tachycardiac atrial fibrillation and very frequent extrasystoles
    21. Uncontrolled type 1 or type 2 diabetes mellitus
    22. Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis
    23. Gilbert’s syndrome
    24. Under medical treatment for asthma or severe asthma exacerbation (ie, hospitalization and/or at least 3-day treatment with systemic steroids) within 1 year of Screening
    25. Acute or chronic bronchitis
    26. Active epilepsy in treatment or past epileptic attack (within 1 year of Screening)
    27. Active or past anxiety
    28. Active depression (with a Patient Health Questionnaire-9 score >10) or past depression
    29. Active hepatitis B or C virus, or HIV-1 or -2 infection (serology test)
    30. Active or past alcohol or drug abuse (including abuse of steroids such as, eg, testosterone, methyltestosterone, danazol, or oxandrolone)
    31. Any score >1 in the neurological assessment of anticholinergic effects at Screening or Day 1
    32. Current treatment with potassium chloride
    33. Known disturbed blood-brain barrier (such as patients with recent [within 1 year of Screening] craniocerebral trauma, chemotherapy, radiation therapy, surgery to the skull and brain, or recent intravenous drug users)
    34. Psoriasis inversa or psoriasis pustulosa generalisata
    35. Any condition or situation that, in the investigator’s opinion, may interfere with the patient’s participation

    General exclusion criteria
    36. Pregnant, breastfeeding, or intending to become pregnant during the study
    37. Female patient who is sexually active and not willing to use acceptable contraceptive methods until study completion
    38. Use of prohibited medications or therapies (see ‘Previous and concomitant medications and therapies’)
    39. Use of other IMPs within 30 days or 5 half-lives (whichever is longer), or participation in this or another clinical study within 30 days before the planned first dosing
    40. Detained officially or legally to an official institute or having been committed to an institution by an order issued either by the judicial or the administrative authorities
    41. Patient or legal guardian is employee of the sponsor or sponsor’s representative or patient or legal guardian is employee or a relative of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints:
    1. Number of patients with ADRs during treatment
    2. Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment
    3. Absolute change in glycopyrronium (GP) plasma concentration from Baseline to Day 15
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline to Day 57 until SFU
    2. Baseline, Day 29, Day 57
    3. Baseline, Day 8, Day 15
    E.5.2Secondary end point(s)
    Key secondary endpoint:
    4. Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29

    Secondary endpoints:
    5. Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57
    6. Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57
    7. Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57
    8. Relative change in total sweat production assessed by GM from Day 29 to Day 57
    9. Proportion of responders assessed by GM at Day 29 and Day 57 (defined by sweat reduction of ≥50%, ≥75%, ≥90% from Baseline)
    10. Absolute change in PRHS from Baseline to Day 29 and Day 57
    11. Absolute change in PRHS from Day 29 to Day 57
    12. Absolute change in the CDLQI score from Baseline to Day 29 and Day 57
    13. Absolute change in the CDLQI score from Day 29 to Day 57
    14. Absolute change in GP plasma concentration from Baseline to Day 8
    15. Absolute change in GP plasma concentration from Day 8 to Day 15
    16. Frequency, severity, and relationship to the IMP of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs
    17. Local tolerability based on the skin reaction score
    18. Neurological assessment of anticholinergic effects
    19. Safety laboratory
    20. 12-lead ECG
    21. Vital signs (heart rate, blood pressure, and body temperature)
    22. Product use per 4 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key secondary Endpoints:
    4. Baseline, Day 29

    Secondary Endpoints:
    5. Baseline, Day 29, Day 57
    6. Day 29, Day 57
    7. Baseline, Day 29, Day 57
    8. Day 29 to Day 57
    9. Baseline, Day 29, Day 57
    10. Baseline, Day 29, Day 57
    11. Day 29, Day 57
    12. Baseline, Day 29, Day 57
    13. Day 29, Day 57
    14. Baseline, Day 8
    15. Day 8, Day 15
    16. Baseline to Day 57 until SFU
    17. Baseline, Day 29, Day 57
    18. Baseline, Day 15, Day 29, Day 43, Day 57
    19. Baseline, Day 29, Day 57 (SFU)
    20. Baseline, Day 57
    21. Baseline, Day 57
    22. Baseline to Day 57
    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 Yes
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Glycopyrronium (GP) plasma concentration
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 40
    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: 40
    F.1.2Adults (18-64 years) No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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. After withdrawal patients will receive standard medical care according to individual needs.
    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 Decision2023-02-21
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-03-06
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