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    Summary
    EudraCT Number:2019-001955-38
    Sponsor's Protocol Code Number:LIN-MD-66
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-07
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-001955-38
    A.3Full title of the trial
    A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants with Functional Constipation (FC) or Irritable Bowel Syndrome with Constipation (IBS-C)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-term Safety of Linaclotide in Pediatric participants of 6 to 17 years of age with Functional Constipation (FC) or Irritable Bowel Syndrome with Constipation (IBS-C).
    A.3.2Name or abbreviated title of the trial where available
    Long-term Safety of Linaclotide in Pediatric Participants with FC or IBS-C.
    A.4.1Sponsor's protocol code numberLIN-MD-66
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/135/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Inc.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-mailglobal-clinical-trials@abbvie.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 nameLinaclotide
    D.3.2Product code A06AX04
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    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 INNLinaclotide
    D.3.9.1CAS number 851199-59-2
    D.3.9.2Current sponsor codeLinaclotide
    D.3.9.3Other descriptive nameLINACLOTIDE
    D.3.9.4EV Substance CodeSUB32529
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number72
    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.IMP: 2
    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 nameLinaclotide
    D.3.2Product code A06AX04
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    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 INNLinaclotide
    D.3.9.1CAS number 851199-59-2
    D.3.9.2Current sponsor codeLinaclotide
    D.3.9.3Other descriptive nameLINACLOTIDE
    D.3.9.4EV Substance CodeSUB32529
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number145
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Functional Constipation (FC)
    E.1.1.1Medical condition in easily understood language
    Functional Constipation is a condition with the symptoms of infrequent, hard stools, and painful defecation.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10010774
    E.1.2Term Constipation
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety of Linaclotide in pediatric participants with FC (total exposure with linaclotide for 24 weeks) who have completed study intervention in the study LIN-MD-64 or IBS-C (total exposure with linaclotide for 52 weeks) who have completed study intervention in Study LIN-MD-62, LIN-MD-63, or LIN-MD-64.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    5.1.1. General Inclusion Criteria (All Participants)
    1.01 Participant weighs ≥ 18 kg at the time the parent/guardian/LAR and/or caregiver has provided signed consent.
    1.02 Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception.
    1.03 Male or female participants must be 6 to 17 years of age (inclusive), at the time the parent/guardian/LAR and/or caregiver provides written informed consent and the participant must provide assent before the initiation of any study-specific procedures.
    1.04 Participants must have completed study intervention in their lead-in study.
    1.05 Female participants of childbearing potential must have a negative pregnancy test at both Screening (Visit 1) and at Study Day 1 (Visit 2)
    5.1.2. Inclusion Criteria for Phase 3 LIN-MD-64 Completers and Phase 2 LIN-MD-63 Completers Who Enroll in LIN-MD-66 Within ≤ 28 Days From Last Study Intervention
    2.01 Participants who turn 18 years of age prior to enrollment must provide consent for the study.
    5.1.3. Inclusion Criteria for Phase 2 LIN-MD-62 or Phase 2 LIN-MD-63 and Phase 3 LIN-MD-64 Completers Who Enroll in LIN-MD-66 After > 28 Days From Last Study Intervention
    3.01 Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test prior to the first dose on the Day 1 Visit (Visit 2).
    3.02 This criterion has been removed
    3.03 This criterion has been removed
    E.4Principal exclusion criteria
    5.2.1. General Exclusion Criteria (All Participants)
    1.01 Participant has an unresolved AE or a clinically significant finding on a physical examination or vital sign assessment along with ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments. Clinical laboratory levels that will be measured are summarized in Table 10-1.
    1.02 Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.
    1.03 Participant is not willing or able to abide by the restrictions regarding concomitant medicine use defined in Section 6.5.
    1.04 Participant received an investigational drug, other than linaclotide, during the 30 days before the Screening Visit (Visit 1) or is planning to receive an investigational drug (other than that administered during this study) or use an investigational device at any time during the study.
    1.05 Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
    1.06 Participant has fecal impaction at the Day 1 Visit (Visit 2).
    1.07 Participant has required manual disimpaction any time prior to study intervention.
    1.08 Participant has any of the conditions described in protocol points a/b/c/d/e.
    1.09 Participant has an acute or chronic condition that, in the investigator's opinion, would limit the participants’ ability to complete or participate in this clinical study.
    1.10 The participant has a condition or is in a situation which, in the investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study.
    1.11 Participant has a known or suspected mechanical bowel obstruction or pseudoobstruction.
    1.12 Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process.
    1.13 Participant has an active anal fissure (Note: history of anal fissure is not an exclusion).
    1.14 Participant has had surgery that meets any of the criteria defined in protocol points a/b/c/d.
    1.15 This criterion has been removed
    1.16 This criterion has been removed
    1.17 Participants with hypothyroidism who have been treated with a stable dose of thyroid hormone in the last three months prior to Screening (Visit 1) must have their history confirmed by both a medical record and a recent (within 2 months of Screening Visit) blood sample. Thyroid function tests, if not recent, must be checked during screening to trial for fT3, fT4 and TSH ,+/- TPO antibodies) prior to the study treatment.
    5.2.2. Exclusion Criteria for LIN-MD-62, LIN-MD-63 and LIN-MD-64 Completers Who Enroll in LIN-MD-66 > 28 Days From Last Study Intervention
    2.01 Participant has a history of nonretentive fecal incontinence
    2.02 This criterion has been removed
    2.03 Participant has a history of drug or alcohol abuse
    2.04 Participant has any of the following conditions:
    a) Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy
    b) Cystic fibrosis
    c) Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening (Visit 1)
    d) Lead toxicity, hypercalcemia
    e) Inflammatory bowel disease
    f) Childhood functional abdominal pain syndrome
    g) Childhood functional abdominal pain
    h) Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study
    i) Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study
    j) History of cancer other than treated basal cell carcinoma of the skin. (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment.)
    k) History of diabetic neuropathy
    2.05 Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids.
    E.5 End points
    E.5.1Primary end point(s)
    No endpoints are specified for this long-term safety study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not Applicable
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Canada
    Israel
    Serbia
    Ukraine
    United States
    Belgium
    Estonia
    Germany
    Hungary
    Italy
    Poland
    United Kingdom
    Bulgaria
    Netherlands
    Spain
    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 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parent/guardian/caregiver should provide written informed consent for children and adolescents.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 120
    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)
    No interventions will be dispensed after the end of the study.
    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 Decision2021-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
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