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    EudraCT Number:2013-001370-20
    Sponsor's Protocol Code Number:OPV116910
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-25
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001370-20
    A.3Full title of the trial
    OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris
    A.4.1Sponsor's protocol code numberOPV116910
    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 SponsorGlaxo Group Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxo Group Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44 208 990 4466
    B.5.5Fax number44 208 990 1234
    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 nameofatumumab
    D.3.2Product code GSK1841157
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNOFATUMUMAB
    D.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeGSK1841157
    D.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Pemphigus Vulgaris
    E.1.1.1Medical condition in easily understood language
    Pemphigus Vulgaris
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10052802
    E.1.2Term Pemphigus vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy, based on disease remission, of ofatumumab SC at a dose of 20 mg administered every 4 weeks (with an additional 20-mg loading dose [ie, 40 mg total] at both Week 0 and Week 4) in subjects with PV.
    E.2.2Secondary objectives of the trial
    -To evaluate the safety and tolerability of ofatumumab SC.
    -To evaluate disease flare/relapse during treatment with ofatumumab SC.
    -To evaluate reductions in steroid dose while maintaining disease control.
    -To determine the extent of B-cell depletion and repletion following ofatumumab SC.
    -To evaluate the immunogenicity of ofatumumab SC.
    -To assess the population pharmacokinetics of ofatumumab SC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for enrollment in the study, subjects must meet all of the following criteria:

    All Subjects
    1. Adults (18 through 70 years of age) with clinically-documented diagnosis of PV for >2 months and <10 years.
    2. History of biopsy consistent with PV (H and E staining and direct
    immunofluorescence). If no history, a biopsy may be performed during the Screening Period.
    3. At least 1 previous episode of a failed steroid taper (ie, disease flare/relapse at a prednisone/prednisolone dose >10 mg/day).
    Additional Criteria Prior to Randomization
    4. Screening anti-Dsg antibodies consistent with a diagnosis of PV (ie, elevated anti-Dsg3 antibodies).
    5. Has initiated and received a stable dose of prednisone/prednisolone from a minimum of 20 mg/day (eg, 0.25 mg/kg/day for an 80-kg person) up to a maximum of 120 mg/day or 1.5 mg/kg/day (whichever is higher) for >= 2 weeks prior to
    randomization. (Note: subjects who are on every-other-day dosing regimens need to change to a daily dosing regimen for >= 2 weeks during the Screening Period in order to qualify.)
    6. Has exhibited PV disease control, defined as no new lesions for >= 2 weeks.

    Additional Criteria for Female Subjects

    7. A female subject is eligible to enter the study if she:
    a. Is of nonchildbearing potential, who is documented as either surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or post-hysterectomy) or is postmenopausal without menses for >2 years. Women who are <2 years postmenopausal are required to have menopausal status confirmed by folliclestimulating hormone (FSH) and estradiol levels at the screening evaluation. If FSH and estradiol levels do not provide confirmation of menopause, subject will be considered to be of childbearing potential.
    b. Is of childbearing potential, defined as a woman who has functional ovaries, ducts, and a uterus with no documented impairment that would cause sterility. This includes women with oligomenorrhea (even severe), women who are perimenopausal, and women who have just begun to menstruate. Subject must:
    - Have a negative serum pregnancy test at screening
    - Agree to the consistent and correct use of acceptable methods of contraception during heterosexual intercourse, beginning when the subject provides informed consent and lasting until 6 months after last dose of investigational product. Acceptable methods of contraception are limited to the following:
    -Oral contraceptives (either combined or progesterone only)
    -Injectable progesterone
    -Levonorgestrel implants
    -Estrogenic vaginal ring
    -Percutaneous contraceptive patches
    -Intrauterine device or intrauterine system with a documented failure rate of <1% per year
    -Male partner sterilization (vasectomy with documentation of
    azoospermia) prior to the female subject’s entry into the study; this male must be the subject’s sole partner
    -Double-barrier method: condom and an occlusive cap (diaphragm or
    cervical/vault caps) with a vaginal spermicidal agent
    -Complete abstinence from heterosexual intercourse

    French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated with, or beneficary of, a social security category.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will not be enrolled:

    1. Diagnosis of pemphigus foliaceus, paraneoplastic pemphigus, or other autoimmune blistering disease (other than pemphigus vulgaris).
    2. Past or current history of hypersensitivity to components of the investigational product or medically significant adverse effects (including allergic reactions) from cetirizine (or antihistamine equivalent) or paracetamol/acetaminophen.
    3. Prior treatment with rituximab without achieving disease control within 6 months of initiating rituximab dosing.
    4. Prior treatment with any of the following within the specified periods (refer toprotocol, table page 32)
    5. Confirmed PML, or neurological findings potentially consistent with PML.
    6. Evidence or history of clinically significant infection including:
    -Chronic or ongoing active infectious disease requiring long-term systemic treatment, including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, or active hepatitis C.
    -Positive test for HBsAg. For HBsAg negative, but anti-HBc positive (regardless of HBsAb status), an HBV DNA test will be performed and the subject will be excluded if results are positive. Consult with a physician experienced in the care and management of subjects with hepatitis B to manage/treat subjects who are
    anti-HBc positive.
    -History of positive serology for human immunodeficiency virus.
    -Previous serious opportunistic or atypical infections.
    -Prior history, or suspicion, of tuberculosis.
    7. Past or current malignancy, except for:
    -Cervical carcinoma Stage 1B or less.
    -Noninvasive basal cell and squamous cell skin carcinoma.
    -Cancer diagnoses with a duration of complete response (remission) >5 years.
    Note: A history of hematologic malignancy excludes a subject from
    participation, regardless of response.
    8. Significant concurrent, uncontrolled medical condition that could affect the subject’s safety, impair the subject’s reliable participation in the study, impair the evaluation of endpoints, or necessitate the use of medication not allowed by the protocol.
    9. Any of the following screening laboratory values:
    -White blood cells (WBC) <3.8 GI/L (<3800/mm3).
    -Neutrophils <2 GI/L (<2000/mm3).
    -Platelets <130 GI/L (<130,000/mm3).
    -Circulating IgG, IgA, or IgM levels <10% of the LLN and requiring treatment in the opinion of the investigator.
    -Alanine aminotransferase (ALT) >2.0 times the upper limit of normal (ULN).
    -Aspartate aminotransferase (AST) >2.0 x ULN.
    -Alkaline phosphatase (ALP) >1.5 x ULN.
    -Bilirubin >1.5 x ULN (except in cases of isolated predominantly indirect hyperbilirubinemia due to Gilbert’s syndrome).
    10. Use of an investigational drug or other experimental therapy within 4 weeks, 5 pharmacokinetic half-lives, or the duration of biological effect (whichever is longer) prior to Screening.
    11. Electrocardiogram (ECG) showing a clinically significant abnormality or showing a QTc interval ≥450 msec (≥480 msec for subjects with a bundle branch block) (ECG to be obtained during Screening/prior to receiving the first dose of study drug).
    12. Woman who is breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Two co-primary efficacy endpoints will be evaluated:
    -Time to SR on minimal steroid therapy (defined as time from randomization to the time the subject initially tapered his/her oral prednisone/prednisolone dose to ≤10 mg/day and maintained ≤10 mg/day of oral prednisone/prednisolone with no new or nonhealing lesions for ≥8 weeks AND maintained that status until Week 60).
    -Duration of remission on minimal steroid therapy (defined as total time [sum] of all periods of remission while on minimal steroid therapy [oral prednisone/prednisolone dose of ≤10 mg/day] up to Week 60).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 60
    E.5.2Secondary end point(s)
    Proportion of subjects achieving remission on minimal steroid therapy (defined as subjects who had an absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of ≤10 mg/day for≥8 weeks) at Week 60.
    -Time to remission while on minimal steroid therapy (defined as time from randomization to the time the subject initially tapered his/her oral prednisone/prednisolone dose to ≤10 mg/day and maintained ≤10 mg/day of oral prednisone/prednisolone with no new or nonhealing lesions for ≥8 weeks) by
    Week 60.
    -Time to initial flare/relapse (defined as the time from randomization to the time that ≥3 new lesions within 1 month appear and do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the randomization visit) by Week 60.
    -Proportion of subjects who did not flare/relapse (defined as subjects who achieved remission on minimal steroid therapy and did not subsequently have a flare of disease) by Week 60. A flare/relapse is defined as new lesions that do not heal spontaneously within 1 week, or when there is an extension of lesions that were present at the randomization visit.
    -Time to remission off steroid therapy by Week 60 (defined as the time from randomization to the time the subject initially tapered off all steroids for ≥8 weeks with an absence of new or nonhealing lesions).
    -Proportion of subjects achieving remission while off steroid therapy by Week 60.
    -Number of days a subject maintained minimal steroid therapy (an oral prednisone/prednisolone dose of ≤10 mg/day in the absence of new or nonhealing lesions) by Week 60.
    -Cumulative dose of corticosteroids.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 60
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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) 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 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 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 No
    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 EEA17
    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
    Korea, Republic of
    Russian Federation
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 121
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 136
    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)
    Subjects completing the study and meeting entry criteria will be offered the option to participate in an extension study (OPV117059), which will start after completion of the Week 60 visit. Subjects who do not participate in the planned extension study will not receive any additional treatment after completion of this study.
    The investigator is responsible for ensuring that consideration has been given to the post study care of the subject’s medical condition. (see Protocol section 5.7)
    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 Decision2014-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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