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    Summary
    EudraCT Number:2015-001678-17
    Sponsor's Protocol Code Number:FFP104-002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-001678-17
    A.3Full title of the trial
    A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects with Moderate to Severely Active Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Pilot Study of FFP104 in Subjects with Crohn’s Disease
    A.4.1Sponsor's protocol code numberFFP104-002
    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 SponsorFast Forward Pharmaceuticals, B.V.
    B.1.3.4CountryNetherlands
    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 supportFast Forward Pharmaceuticals, B.V
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFast Forward Pharmaceuticals, B.V
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressYalelaan 46
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031302534321
    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 FFP104
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severely Active Crohn’s disease
    E.1.1.1Medical condition in easily understood language
    Crohn's disease is a type of inflammatory bowel disease (IBD) that may affect any part of the gastrointestinal tract from mouth to anus.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and tolerability of intravenously administered FFP104 in subjects with active Crohn’s disease following repeat doses of FFP104.
    E.2.2Secondary objectives of the trial
    Assess the clinical response (reduction of CDAI from baseline by 100 points and by 70 points) and clinical remission (CDAI < 150) at 6 weeks (Day 42) and at other time points in the trial
    Assess effects of intravenously administered FFP104 in subjects with active Crohn’s disease on the mucosa:
    Endoscopy using the Crohn’s Disease Endoscopy Index of Severity (CDEIS) (Day 42)
    Histology (including immune cell infiltration assessments) (Day 42)
    Faecal calprotectin (Day 28, 42, 84)
    C-reactive protein (CRP) (all visits)
    Characterize the pharmacokinetics (systemic exposure after i.v. dosing) of FFP104 in subjects with active Crohn’s disease.
    Assess the pharmacodynamics of intravenously administered FFP104 in subjects with active Crohn’s disease
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Willing and able to provide written informed consent.
    Willing and able to comply with all study procedures and visits.
    Male or female aged between 18 and 75 years, inclusive.
    Body Mass Index (BMI) between 18-35 kg/m2.
    Clinical diagnosis of Crohn’s disease involving the colon and/or ileum for at least 3 months from Screening confirmed by radiological, endoscopic or histological evidence.
    Active Crohn’s disease defined as a Crohn’s Disease Activity Index (CDAI) score between 220 and 450, inclusive, at Screening.
    Active inflammatory disease as defined by CDEIS ≥ 8 or a CDEIS ≥ 4 in cases of isolated ileitis or post-ileocecal resection (as determined by a Central Blinded Reader).
    TNF-naïve or previously exposed to anti-TNF therapy at a registered dose (such as infliximab, adalimumab or certolizumab pegol) with treatment discontinued at least 8 weeks prior to Baseline due to inadequate response, loss of response or intolerance as judged by the Investigator.
    Previous exposure to one induction regimen of vedolizumab (maximum 5 infusions at a registered dose) is allowed if treatment has been discontinued for at least 75 days prior to Baseline (Day 0) due to inadequate response or intolerance.
    Must have adequate renal and hepatic function as adjudged by the Investigator.
    In good health (other than Crohn’s disease) as evidenced by medical history and physical examination.
    E.4Principal exclusion criteria
    Subjects who are pregnant, breastfeeding, or of child-bearing potential and not using a medically accepted form of contraception. Male participants, with their partners, unwilling to use medically accepted contraception throughout the study.
    Presence of ileostomies, colostomies or rectal pouches or history of proctocolectomy or total colectomy. Subject has an ostomy or ileoanal pouch (subjects with a previous ileo-rectal anastomosis are not excluded).
    Subject has short bowel syndrome as determined by the Investigator.
    History of evidence of colonic mucosal dysplasia.
    Subject currently has a significant mechanical obstruction (stenosis or stricture).
    Subject has a current diagnosis of ulcerative or indeterminate colitis.
    Immunization with a live vaccine within 4 weeks of Screening, with the exception of influenza vaccine and no planned immunizations within the period of the study.
    Active or latent tuberculosis (TB) or tuberculosis infection; TB assessment and prophylaxis will be performed as per local biologicals regulations and guidelines.
    Subjects with a history of or ongoing chronic or recurrent infectious disease within the 12 months prior to Screening.
    Positive stool culture for Clostridium within the last 6 months prior to Screening.
    Use of prohibited medications/procedures
    Use of any prescription medications/products (with the exception of prescription medications for contraception and/or medications deemed acceptable by the Investigator and Sponsor).
    Use of any over the counter (OTC), non-prescription preparations within 7 days prior to the Check-in visit unless deemed acceptable by the Investigator and Sponsor.
    Current or recent history (within 6 months of Screening) of drug or substance abuse
    Subjects with known clinically significant cardiac disease (e.g., myocardial infarction or stroke within 6 months prior to Screening, unstable angina, claudication, etc.), or evidence of a clinically significant electrocardiogram (ECG) abnormality at Screening
    A history of significant neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary or metabolic disease within 30 days of the Screening visit, as judged by the Investigator.
    Have a family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event including deep vein thrombosis, stroke, myocardial infarction, pulmonary embolus, and peripheral arterial thromboembolic events.
    Subject has had a positive hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV] or a positive HIV antibody screen at time of the Screening visit.
    Evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH) or abnormal hepatic markers (AST, ALT, ALP, or total bilirubin > 1.5 x upper limit of normal) at the time of the Screening visit.
    Abnormal renal function (BUN or creatinine >1.25 x upper limit of normal) at the time of the Screening visit.
    WBC <4 x 103/mm3; platelets <150 x 103/mm, hemoglobin < 6.2 mmol/L at the time of the Screening visit.
    Subjects with evidence of other serious, significant, acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study.
    History of malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability will be assessed through clinical laboratory tests, vital signs, physical exams, and adverse event assessments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the primary endpoints all time points in the trial
    E.5.2Secondary end point(s)
    Proportion of subjects achieving clinical response (decrease of CDAI score by ≥100 points from baseline) (all time points)
    Proportion of subjects achieving clinical remission (attainment of absolute CDAI score of 150 points or less from baseline) (all time points)
    Proportion of subjects achieving partial response (decrease of CDAI score by >70 points from baseline) (all time points)
    Difference in CDAI score between FFP104 treated subjects and placebo subjects in each arm of the study
    Time to response (decrease in CDAI score by >100 points)
    Time to partial response (decrease of CDAI score by >70 points)
    Percent change in CDAI score from baseline at week 4, 6 and 12 (Days 28, 42, 84) post first dose.
    Change from baseline in CDEIS score at week 6 (Day 42) post first dose as determined by a Central Blinded Reader
    Proportion of subjects with endoscopic response defined as CDEIS decrease from baseline > 5 points (for patients with initial isolated ileitis or post-ileocecal resection a decrease from baseline in CDEIS of at least 50%) at week 6 (Day 42) as determined by a Central Blinded Reader
    Proportion of subjects with endoscopic remission defined as CDEIS < 6 (for subjects with initial isolated ileitis or post-ileocecal resection a score <2) at week 6 (Day 42) as determined by a Central Blinded Reader
    Proportion of subjects with endoscopic complete remission defined as CDEIS < 3 (only for subjects in which both colon and ileum are involved) at week 6 (Day 42) as determined by a Central Blinded Reader
    Change from baseline in Histological Crohn’s Disease Score (including immune cell infiltration assessments) at week 6 (Day 42)
    Percent change from baseline in faecal calprotectin level at week 6 (Day 42) and all other study time points post first dose (Day 0)
    Percent change from baseline in CRP at week 6 (Day 42) and all other time points post first dose (Day 0).
    Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at week 6 (Day 42) post first dose (Day 0)
    Change of SF36, EQ5D and WPAI-CD from baseline at week 6 (Day 42) post first dose
    Characterize the pharmacokinetics (systemic exposure after i.v. dosing) of FFP104 in subjects with active Crohn’s disease after multiple exposure
    E.5.2.1Timepoint(s) of evaluation of this end point
    see text above
    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 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 trial3
    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 concerned1
    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 years2
    E.8.9.1In the Member State concerned months
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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
    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 Decision2015-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-03
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