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    Summary
    EudraCT Number:2017-004772-65
    Sponsor's Protocol Code Number:PROCTO
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-04
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-004772-65
    A.3Full title of the trial
    Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO)
    A.3.2Name or abbreviated title of the trial where available
    PROCTO
    A.4.1Sponsor's protocol code numberPROCTO
    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 SponsorParaTech A/S
    B.1.3.4CountryDenmark
    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 supportParaTech A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationParaTech A/S
    B.5.2Functional name of contact pointCEO, Professor, PhD
    B.5.3 Address:
    B.5.3.1Street AddressDr. Neergaards Vej 3
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.6E-mailinfo@para-tech.dk
    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.3.2Product code TSO
    D.3.4Pharmaceutical form Suspension for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTSO
    D.3.9.3Other descriptive nameSUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML
    D.3.9.4EV Substance CodeSUB31749
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number450 to 550
    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 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 Yes
    D.3.11.13.1Other medicinal product typeThe product TSO is consisting of living embryonated eggs (ova) of the intestinal pig whipworm Trichuris suis.
    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 placeboSuspension for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis (UC) is a long-term condition that results in inflammation and ulcers of the colon and rectum. The primary symptom of active disease is abdominal pain and diarrhea mixed with blood
    Colitis ulcerosa - blødende tyktarmsbetændelse
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of the present “PROCTO” trial is to demonstrate that administration of 7500 TSO every second week over 24 weeks will reduce the intestinal inflammation in moderate UC by achieving clinical remission by full Mayo disease score (primary endpoint).
    E.2.2Secondary objectives of the trial
    The patients should achieve a clinically meaningful response defined as reduction in full Mayo disease score, complete steroid free clinical remission, endoscopic remission, symptomatic remission, time to achieve disease remission (as defined by pMayo score), time to achieve disease response (as defined by pMayo score) and decrease in disease severity over time assessed by pMayo scores (secondary endpoints). Further, the PROCTO trial aims to evaluate steroid use, patient withdrawals due to worsening of disease, mucosal healing, and a reduction in the inflammatory biomarker calprotectin and to explore 1) a local and systemic immune therapeutic effect through antibody stimulation and cytokine regulation, and 2) a shift in the gut microbiota profile to down regulate pro-inflammatory bacteria in UC patients and 3) the patient-reported outcome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who meet all of the following criteria can be enrolled into the trial:
    1. Signed informed consent
    2. Between 18 and 75 years of age
    3. Established diagnosis of UC confirmed by endoscopic (sigmoidoscopy) and histological criteria, within 3 months prior to screening
    4. Disease extension corresponding to E2 (left side colitis) or E3 (extensive colitis) according to the Montreal Classification, i.e. at least 15 cm from anal verge, confirmed by an index sigmoidoscopy
    5. Mayo-score between 6 and 10 and including 6 and 10 corresponding to moderately active disease
    6. Calprotectin ≥ 250 µg/g and an endoscopic Mayo score ≥ 2
    7. Negative pregnancy test in females of childbearing potential and the use of birth control
    8. No treatment or if treated with 5-Aminosalicyl acid (5-ASA): 5-ASA ≥ 8 weeks with a stable dose for at least 4 weeks both oral and rectal use
    9. Tapered down from last oral steroid ≥ 4 weeks ago
    E.4Principal exclusion criteria
    Patients who meet one of the following criteria, are not allowed to be enrolled into the trial:
    1. Disease extension corresponding only to E1 (proctitis), i.e. less than 15 cm from the anal verge
    2. Bowel surgery, except appendectomy and removal of polyps
    3. Septic complications
    4. Evidence of infectious diarrhea (e.g. pathogenic bacteria or Clostridium difficile toxin in stool)
    5. Abscess, perforation, active fistula or perianal lesions
    6. Abnormal hepatic function (ALAT or ALP > 2.5 x ULN at screening), liver cirrhosis, or portal hypertension
    7. Abnormal renal function (Creatinine > ULN) at screening
    8. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient’s compliance or the interpretation of the results
    9. Any condition associated with significant immunosuppression
    10. Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the last 3 months prior to baseline
    11. Treatment with systemic broad-spectrum antibiotics (e.g., metronidazole or ciprofloxacin), anti-parasitic medications, or probiotic (e.g. facal transplantation) medication within the last 4 weeks prior to baseline, except for probiotic lactobacillus or bifidobacteria within 2 weeks prior to baseline (and minimum 1 week before screening visit (sampling and biopsies))
    12. Treatment with systemic glucocorticosteroid within the last 4 weeks or treatment with topical steroid within the last 2 weeks prior to baseline
    13. Application of systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤ 350 mg/d which is allowed
    14. Immunization with live vaccines within 12 weeks prior to baseline or during the trial (the Corona vaccines are not per se live vaccine)
    15. Travelling to rural districts in countries outside of Europe, USA, Australia or Canada within the last 12 weeks prior to baseline or during trial participation. If patients travel outside of Europe, USA, Australia or Canada they must be tested negative in the standard stool tests (parasites, bacteria and virus) when they return, as at the screening visit.
    16. Well-founded doubt about the patient’s cooperation, (e.g., addiction to alcohol or drugs).
    17. Existing or intended pregnancy or breast-feeding
    18. Participation in another clinical trial within the last 60 days, simultaneous participation in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    • To achieve clinical remission defined as full Mayo score ≤ 2 at 24 weeks (long-term efficacy) (ITT, PP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Full Mayo: Measurements at week -2 to -1 at the screenings visit and at 24 week as sigmoidoscopy will be performed to be able to calculate full Mayo score
    E.5.2Secondary end point(s)
    Secondary endpoints
    • To achieve reduction of full Mayo score of 4 or more steps at 24 weeks (ITT, PP, complete steroid-free)
    • To achieve complete steroid free clinical remission defined as full Mayo score ≤ 2 at 24 weeks (long-term efficacy) (complete steroid-free)
    • To achieve endoscopic remission defined as mucosal appearance Mayo sub-score of 0 or 1 at 24 weeks (long-term efficacy) (ITT, PP, complete steroid-free)
    • To achieve symptomatic remission defined as stool frequency Mayo sub-score of 0 or 1 and rectal bleeding Mayo sub-score of 0 at 12 weeks (short-term efficacy) and at 24 weeks (long-term efficacy) (ITT, PP, complete steroid-free)
    • To reduce time to achieve remission defined as time to achieve a pMayo score ≤ 1 and time to achieve symptomatic remission defined as stool frequency Mayo sub-score of 0 or 1 and rectal bleeding Mayo sub-score of 0 (0-24 weeks) (ITT, PP, complete steroid-free)
    • To reduce time to achieve response defined as time to achieve reduction in pMayo score of 3 or more steps (0-24 weeks) (ITT, PP, complete steroid-free)
    • To decrease disease severity assessed by pMayo scores at visit 7 to 13.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Full Mayo: Measurements at week -2 to -1 at the screenings visit and at 24 week as sigmoidoscopy will be performed to be able to calculate full Mayo score
    pMayo: Measurements at week -2 to -1, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 and at the follow visit week 30
    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) 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of Treatment (EOT) Visit (Visit 13 or withdrawal visit) at week 24
    Follow-up visit (visit 14, week 30)
    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 months8
    E.8.9.1In the Member State concerned days7
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state120
    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)
    Treatment after study end (after FU visit) is left to the investigator’s discretion. Patients being in remission at the EOT/withdrawal visit should not receive additional concomitant treatment for UC until completion of their follow-up visit (visit 14, week 30). In cases, where a patient is not in remission at the EOT/withdrawal visit, the patient could receive symptomatic treatment according to accepted standards in the discretion of the investigator.
    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 Decision2018-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-10
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