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    Summary
    EudraCT Number:2021-000854-24
    Sponsor's Protocol Code Number:VE-CIP2001/2021
    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:2021-09-29
    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 number2021-000854-24
    A.3Full title of the trial
    Velusetrag for the treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). A multicenter double-blind, placebo-controlled, cross-over, multiple (n=1) trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II multicenter clinical trial, with treatment randomly assigned, in which patient nor physician are aware of the assigned treatment, active or placebo, to evaluate efficacy and safety of Velusetrag 15 mg (3 x 5 mg capsule) in patients with Chronic Intestinal Pseudo-Obstruction (CIPO)
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberVE-CIP2001/2021
    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 SponsorALFASIGMA S.P.A.
    B.1.3.4CountryItaly
    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 supportAlfasigma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlfasigma .S.p.A.
    B.5.2Functional name of contact pointEarly Stage Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressVia Ragazzi del '99
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40133
    B.5.3.4CountryItaly
    B.5.4Telephone number+39051489619
    B.5.5Fax number+390516489671
    B.5.6E-mailalessandro.ble@alfasigma.com
    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 nameVelusetrag
    D.3.2Product code [TD-5108 hydrochloride]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNVelusetrag
    D.3.9.1CAS number 866933-51-9
    D.3.9.2Current sponsor codeTD-5108
    D.3.9.3Other descriptive nameTHRX-199687 hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboCapsule, hard
    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
    Chronic intestinal pseudo-obstruction (CIPO) is a rare, severe condition characterized by an impairment of coordinated propulsive activity in the intestinal tract resulting in a clinical picture similar to that of mechanical intestinal obstruction, although in the absence of any lesion occluding the gut.
    CIPO can be idiopathic, when no primary underlying disorder is demonstrated, or secondary, when related to systemic diseases.
    E.1.1.1Medical condition in easily understood language
    Chronic intestinal pseudo-obstruction (CIPO) is a rare disease impacting the intestinal motility, potentially invalidating.
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to investigate the safety, tolerability and efficacy of velusetrag in improving the symptoms severity associated with CIPO, in subjects with idiopathic CIPO and CIPO secondary to neurodegenerative or demyelinating conditions (e.g., Parkinsonian Syndromes, multiple sclerosis, etc.).
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women aged 18-80 years.
    2. Subjects with history of chronic idiopathic intestinal pseudo-obstruction or CIPO secondary to neurodegenerative or demyelinating disease.
    3. Subjects with estimated oral caloric intake of at least 30% of the daily age- and sex-recommended caloric intake (stage 0, 1 or 2 of the “artificial food need” scale, see 21.3 Appendix 3: Artificial Food Need" (AFN) Scale for CIPO patients).
    4. Subjects with at least 2 out of 4 CIPO gastrointestinal symptoms (i.e., abdominal pain, bloating, nausea and vomiting), each of the 2 with a score =3 (on a 0 to 4 scale) collected on the gastrointestinal symptom questionnaire at Day -1
    5. Subjects accepting to provide and legally capable of providing free and informed consent to all procedures included in the protocol.
    6. All sexually active male participants who are partner of women of childbearing potential must use condom during intercourse until the 90th day after the end of the entire study.
    7. All female participants must be:
    • of non-childbearing potential, i.e.: i) post-menopausal (at least 2 years without spontaneous menses), or ii) surgically sterile (bilateral tubal occlusion, or hysterectomy), or iii) ablation of both ovaries
    or
    • of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception (i.e., with failure rate of less than 1% per year) until the end of the entire study.
    E.4Principal exclusion criteria
    1. Subjects with primary CIPO or CIPO secondary to other known endocrine/metabolic, autoimmune diseases and neurologic conditions other than neurodegenerative or demyelinating diseases.
    2. Subjects with conditions characterized by mechanical intestinal obstruction.
    3. Nasogastric tube, gastrostomy tube, or jejunostomy feeding tube in place at randomization or planned throughout the duration of the study, or artificial food need scale stage 3 (“total non-oral nutrition”, see 21.3 Appendix 3: Artificial Food Need" (AFN) Scale for CIPO patients).
    4. Presence of untreated clinically relevant thyroid dysfunction or known thyroid dysfunction not well controlled by treatment (e.g., subjects with abnormal thyroid stimulating hormone [TSH], and, if available, triiodothyronine [T3] and thyroxin [T4] levels) deemed clinically significant by the Investigator.
    5. Subjects with history of diabetes at screening.
    6. Clinically significant ECG abnormalities (e.g., ST segment elevation or depression suggestive of ischemia, partial or complete left bundle branch block [LBBB]) at Screening and randomization.
    7. Screening ECG with a QTcF >450 msec in males or >470 msec in females or family history of sudden cardiac death.
    8. Subjects requiring a low galactose diet.
    9. Hypersensitivity or documented intolerance to lactulose, lactose or any excipient of the lactulose preparation to be used for L-BT.
    10. History of sensitivity to velusetrag, or any of the velusetrag or placebo excipients.
    11. Use of scopolamine or erythromycin within 2 weeks prior to Screening and/or planned throughout the duration of the study.
    12. Use of 5-HT4 receptor agonists (e.g., prucalopride, cisapride, clebopride and cinitapride) within 5 days prior to randomization and/or planned throughout the duration of the study
    13. Use of opioids within 8 weeks from screening and/or planned throughout the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change in weekly global gastrointestinal symptoms average index score from start to the end of each treatment period.
    The weekly global gastrointestinal symptoms average index score is obtained by averaging the scores for each of the 4 symptoms assessed weekly: abdominal pain, bloating, nausea and vomiting.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 7 days
    E.5.2Secondary end point(s)
    1. Change in waist circumference from start to the end of each treatment period.
    2. Proportion of subjects with 1-point improvement in weekly global gastrointestinal symptoms average index score from start to the end of each treatment period.
    3. Change in individual symptoms score from start to the end of each treatment period for:
    o Abdominal Pain
    o Bloating
    o Nausea
    o Vomiting
    4. Change in number of weekly bowel movements from start to the end of each treatment period (only in subjects with Bristol stool scale type 1 or 2 at the start of the treatment period).
    5. Change in number of weekly complete evacuations from start to the end of each treatment period (only in subjects with Bristol stool scale type 1 or 2 at the start of the treatment period).
    6. Change in stool type at the Bristol stool scale from start to the end of each treatment period.
    7. Change in weekly bowel habit satisfaction score from start to the end of each treatment period measured using a scale from 0 to 10.
    8. Change from start in orocecal transit time measured using lactulose breath test (only at the end of the first treatment period).
    9. Change in serum albumin, pre-albumin, vitamin B12 and folic acid levels from start of each treatment period to the end of each 2 week wash out period (or follow up period).
    10. Proportion of days with change in permitted medications used to relieve main CIPO gastrointestinal symptoms during each treatment period and wash out period (or follow up period):
    o Proportion of days with dose increased compared to the start of the period.
    o Proportion of days with dose decreased compared to the start of the period.
    o Proportion of days with drug added compared to the start of the period.
    o Proportion of days with drug removed compared to the start of the period.
    11. Change in quality of life (SF-12) from the start to the end of each treatment period.
    12. Number of CIPO-related hospitalizations during the treatment periods.
    13. Change in stage of the “artificial food need” scale from start to the end of each period.
    14. Number of pseudo-obstruction episodes based on investigator’s judgement from start to the end of each period.
    15. Change from the end of each treatment period to the ends of the first and the second week of wash out (or follow up period) in:
    o weekly abdominal pain score.
    o weekly bloating score.
    o weekly nausea score.
    o weekly vomiting score.
    o weekly global gastrointestinal symptoms average index score.
    o number of weekly bowel movements (only in subjects with Bristol stool scale type 1 or 2 at the start of the treatment period).
    o number of weekly complete evacuations (only in subjects with Bristol stool scale type 1 or 2 at the start of the treatment period).
    o stool type at the Bristol stool scale.
    o weekly bowel habit satisfaction score measured using a scale from 0 to 10.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1-28-43-70-85-112-127-154-169
    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.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 Yes
    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 trial1
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 12
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 16
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation MDE Services Group Limited
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-12
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