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    The EU Clinical Trials Register currently displays   37215   clinical trials with a EudraCT protocol, of which   6122   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2008-004587-38
    Sponsor's Protocol Code Number:M10-467
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-31
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2008-004587-38
    A.3Full title of the trial
    A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Hidradenitis Suppurativa
    A.4.1Sponsor's protocol code numberM10-467
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbott GmbH & Co. KG
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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. name Humira 40 mg solution for injection in pre-filled syringe
    D. of the Marketing Authorisation holderAbbott Laboratories Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdalimumab
    D.3.9.1CAS number 331731-18-1
    D.3.9.3Other descriptive nameABT-Humira
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hidradenitis Suppurativa (HS) is a painful, chronic, skin disease characterized by recurrent inflamed nodules, abscesses, and fistulas, which may heal with scarring. The most commonly involved anatomic locations are the inguino-crural and axillary folds, with sub-mammary folds (in women) and the perineal area less commonly involved.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    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 clinical efficacy and safety of adalimumab in subjects with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine maintenance of efficacy and continued safety of adalimumab 40 mg for an additional 36 weeks. The pharmacokinetics and immunogenicity of adalimumab following subcutaneous (SC) injection will also be assessed.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A mechanism of action substudy will be conducted. The objective of the substudy is to determine the in vivo mechanism of adalimumab in the resolution of HS lesions. Skin biopsy samples will be obtained from approximately 15 subjects participating in M10-467 at several prospectively selected sites at Baseline and Week 16.

    Each subject will have biopsies taken of lesional skin. Analysis of skin biopsies may include, but is not limited to, evaluation of cytokine expression, effector cells, transcription factors, and immunological markers of inflammation. Please refer to Appendix R on page 114 of the protocol.
    E.3Principal inclusion criteria
    1. Male and female subjects at least 18 years of age;
    2. Subjects must have a diagnosis of HS for at least 6 months (180 days) prior to
    Baseline that involves at least two distinct anatomic areas (e.g., left and right
    axilla; or left axilla and left inguinal-crural fold);
    3. Subjects must be unresponsive or intolerant, as determined by the investigator, to oral antibiotics for treatment for their HS;
    4. Subject must have stable hidradenitis suppurativa for at least 2 months (60 days)
    before Screening and also at the Baseline visit as determined by subject interview
    of his/her medical history;
    5. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. The results of the serum pregnancy test performed during the Screening Period and urine pregnancy test performed at the Baseline Visit must be negative.
    Examples of approved methods of birth control include the following:
    ● Barrier methods (condoms or intrauterine device)
    ● Contraceptives (oral, parenteral, transdermal or implantable) for three months
    (90 days) prior to study drug administration
    ● Vasectomized partner
    6. Subject has a negative PPD test (or equivalent) and CXR (PA and lateral view) at
    Screening (See Section of the study protocol). If the subject had a positive PPD test (or equivalent), has had a past ulcerative reaction to PPD placement and/or a CXR consistent with prior TB exposure, the subject must initiate, or have documented completion of a course of anti-TB therapy; (See Section of the protocol).
    7. Subject has a PGA of at least moderate disease (score of ≥ 3) at the Baseline visit;
    8. Subject is judged to be in good general health, as determined by investigator based upon the results of a medical history, laboratory evaluations, chest x-ray (CXR), 12-lead ECG, and the physical examination performed during the Screening period and confirmed at Baseline;
    9. Ability and willingness to self-administer SC injections or have available qualified
    person(s) who can reliably administer SC injections;
    10. Ability and willingness to give written informed consent and to comply with the
    requirements of the study protocol.
    E.4Principal exclusion criteria
    1. Prior treatment with adalimumab or other anti-TNF therapy (e.g., infliximab or etanercept), or participation in an adalimumab trial;
    2. Any other active skin disease or condition (e.g., bacterial, fungal or viral infection)
    that may interfere with assessment of hidradenitis suppurativa;
    3. Subjects on allowable oral and/or topical antibiotic treatment for HS who have
    not been on a stable dose for at least 4 weeks prior to the Baseline visit.
    (See Section 5.2.3 of the study protocol for medications).
    4. Subject received systemic non-biologic therapies with potential therapeutic impact
    for hidradenitis suppurativa < 4 weeks prior to Baseline visit (other than oral and/or topical antibiotics);
    5. Received any investigational agent within 30 days or 5 half lives prior to Baseline
    (whichever is longer), or within a duration of its known pharmacological activity;
    6. Subject received UVB phototherapy within 2 weeks of Baseline;
    7. Subject received PUVA phototherapy within 4 weeks of Baseline;
    8. Prior exposure to Tysabri® (natalizumab);
    9. Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or
    IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals,
    or oral antifungals within 14 days prior to Baseline; except as required as part of an anti-TB regimen;
    10. History of moderate to severe congestive heart failure (NYHA class III or IV),
    recent cerebrovascular accident and any other condition which, in the opinion of
    the investigator, would put the subject at risk by participation in the protocol;
    11. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS
    demyelinating disease;
    12. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,
    human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
    chronic recurring infections or active TB;
    13. Known hypersensitivity to the excipients of adalimumab as stated in the label;
    14. Positive pregnancy test at Screening or Baseline;
    15. Female subjects who are breast-feeding or considering becoming pregnant during the study;
    16. Evidence of dysplasia or history of malignancy (including lymphoma and
    leukemia) other than a successfully treated non-metastatic cutaneous squamous
    cell, basal cell carcinoma or localized carcinoma in situ of the cervix;
    17. History of clinically significant drug or alcohol abuse in the last 12 months;
    18. Clinically significant abnormal screening laboratory results as evaluated by the Investigator;
    19. Subject is considered by the Investigator, for any reason, to be an unsuitable
    candidate for the study and not able to comply with the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the proportion of subjects achieving clinical response, defined as achieving a PGA of clear, minimal, or mild, with a minimum of 2 grades improvement (reduction) from Baseline on the PGA at 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 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. 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 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 Yes
    E. description
    Different dose of the same IMP
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study is defined as the date of the last subject's last visit or the actual date of follow-up contact, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 150
    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)
    Following discontinuation of the study drug, the subject will be treated in accordance with the Investigator's best clinical judgement.
    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 Decision2009-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-19
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