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    Summary
    EudraCT Number:2015-001780-40
    Sponsor's Protocol Code Number:11069
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-001780-40
    A.3Full title of the trial
    A multi-centre, double blind, randomised, placebo-controlled, parallel group, phase II trial to determine the efficacy of intra-nodular injection of anti-TNF to control disease progression in early Dupuytren’s disease, with a dose response.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Repurposing anti-TNF for treating Dupuytren’s disease.
    A.3.2Name or abbreviated title of the trial where available
    Repurposing anti-TNF for treating Dupuytren's disease
    A.4.1Sponsor's protocol code number11069
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN27786905
    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 SponsorUniversity of Oxford, Clinical Trials and Research Governance
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHealth Innovation Challenge Fund, Wellcome Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing support180 Therapeutics LP
    B.4.2CountryUnited States
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie 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.3.1Product nameAdalimumab
    D.3.4Pharmaceutical form 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 INNAdalimumab
    D.3.9.4EV Substance CodeAS1
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdalimumab
    D.3.9.4EV Substance CodeAS2
    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.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 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
    Dupuytren's disease
    E.1.1.1Medical condition in easily understood language
    Nodule and cord thickening in the palm of the hand.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013872
    E.1.2Term Dupuytren's contracture
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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
    Part 1: To establish an effective dose of adalimumab for downregulating the myofibroblast phenotype in participants with Dupuytren’s disease.

    Part 2: To determine if injection with adalimumab is superior to placebo injection of normal saline in controlling disease progression in participants with early Dupuytren’s disease.
    E.2.2Secondary objectives of the trial
    Part 1. To determine the safety and effectiveness of the drug being investigated in patients with Dupuytren’s disease using laboratory analysis of tissue, clinical assessment and questionnaires.

    Part 2. To compare the development of early Dupuytren’s disease, flexion deformities of the fingers and impairment of hand function for patients on each treatment using clinical assessments and questionnaires. To assess the acceptability of injections to patients and to monitor for adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participant is willing and able to give informed consent for participation in the study.
    • Male or Female, aged 18 years or above.
    • Part 1: Diagnosed with DD affecting the fingers resulting in flexion deformities of ≥30° at the metacarpophalangeal joint and or the proximal interphalangeal joint with impaired hand function and awaiting surgery.
    or
    Part 2: Patients with early disease nodules who also show progression of the disease in the previous 6 months with flexion deformities of their fingers of ≤30° at the metacarpophalangeal and/or at the proximal interphalangeal joint, i.e. total flexion deformity of up to 60°.
    • The DD nodule to be treated must be distinct and identifiable.
    • Female participants of child bearing potential, and male participants whose partner is of child bearing potential, must be willing to ensure that they or their partner use effective contraception throughout the treatment period and for 5 months following the last research injection. Acceptable methods of contraception include: a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods), injectables, the combined oral contraceptive pill (at a stable dose for at least 3 months before entering the study), an intrauterine device, vasectomised partner, or true sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant).
    • Participant results from safety screening tests within normal ranges within 12 weeks of enrolment, with the exception that an earlier clear CXR result may be used where this is in accordance with the time frames of local standard procedures for anti-TNF screening.
    • Able (in the Investigators opinion) and willing to comply with all study requirements.
    • Willing to allow his or her general practitioner to be notified of participation in the study.
    • Sufficient language fluency to ensure informed consent is obtained and to complete the questionnaires pertaining to hand function.
    E.4Principal exclusion criteria
    • Part 1: Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid injection or radiotherapy to treat Dupuytren’s disease in the digit concerned.
    or
    • Part 2: Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid injection to the digit to be treated or radiotherapy to treat Dupuytren’s disease in the hand concerned.
    • Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for 5 months following last injection.
    • Male participant who is planning a pregnancy during the course of the study and for 5 months following last injection.
    • Significant renal or hepatic impairment.
    • Part 1. Scheduled elective surgery or other procedures requiring general anaesthesia during the study other than the scheduled Dupuytren’s surgery

    • Participant who has ever been diagnosed with cancer, is terminally ill or is inappropriate for placebo medication
    • Systemic inflammatory disorder such as RA or inflammatory bowel disease.
    • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
    • Participated in another research study involving an investigational medicinal product in the past 12 weeks.
    • Known allergy to any anti-TNF agent.
    • Have HIV or hepatitis B or C.
    • Known to have an infection or history of repeated infections.
    • History of Tuberculosis (TB).
    • Have Multiple Sclerosis (MS) or other demyelinating disease.
    • History of local injection site reactions.
    • Needle phobia.
    • Have moderate or severe heart failure.
    • Part 1: Being treated with anticoagulants, including warfarin.
    • Have known lung fibrosis (thickening of lung tissue).
    • Being treated with concomitant biologic DMARDS.
    • Have received a live vaccine within the previous 4 weeks. Patients may receive concurrent vaccinations but must avoid the use of live vaccines for 12 weeks after their last injection.
    • Part 2. Patients at risk of Hepatitis B infection.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1. Laboratory analysis of tissue: Expression of mRNA for α-SMA from patients on each treatment (IMP or placebo).

    Part 2. Change in hardness of selected nodule for participants on each treatment baseline and 12 months after first treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1. Dupuytren’s tissue excised during surgery at 12-18 days post-injection will be examined.


    Part 2. 12 months after first treatment.
    E.5.2Secondary end point(s)
    Part 1:
    1. Expression of mRNA for COL-1A1, COL-3A1 and cadherin 11
    2. Levels of α-SMA and collagen proteins.
    3. Hardness of selected nodule
    4. Ultrasound imaging of nodule size.
    5. Adverse event assessment comparing active and placebo groups using visual inspection of injection site, surgery site and laboratory reports.
    6. Visual assessment of surgical wounds using hand photographs of all participants on each treatment.

    Part 2:
    1. Change in hardness of selected nodule for participants on each treatment at baseline, 3, 6, 9, 12 & 18 months after first treatment.
    2. Ultrasound imaging of nodule size.
    3. Range of motion of the affected digit.
    4. Grip strength.
    5. Participant Reported Outcomes: Michigan Hand Outcomes Questionnaire (MHQ)
    6. Participant identified activity most restricted by DD scored on a scale of 1-10.
    7. Injection experience
    8. Adverse event monitoring comparing active and placebo groups using visual inspection of injection site
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1:
    1 and 2. Analysis of tissue removed during surgery at 12-18 days post-treatment.
    3 and 4. Measured before treatment and at 2 weeks post-treatment.
    5. Observation at each research visit. Injection site assessment immediately after injection and 2 weeks later. Health check phone call 1 week post treatment. Surgery site assessment at 2 weeks post-surgery.
    6. 2 and 4 weeks post surgery.

    Part 2:
    1. At 3,6, 9 & 18 months after first treatment.
    2, 3, 4 and 5. Before, and at 3, 6, 9, 12 and 18 months after first treatment.
    6. During the 18 month post first treatment.
    7. After each injection at baseline, 3, 6 and 9 months.
    9. Observation at week 0 and 3, 6, 9 and 12 months.
    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 Yes
    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) 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years5
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state193
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 228
    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 in Part 1 will proceed to scheduled surgery and continue normal care. Continuing with the injection treatment will then be unnecessary. In Part 2 patients will receive a total of 4 injections (at baseline, 3, 6 and 9 months)in the nodule then will be monitored for a further 9 months. Continued injection treatment would be inappropriate until the efficacy and safety of the treatment is established.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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