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    Summary
    EudraCT Number:2021-002549-13
    Sponsor's Protocol Code Number:CSUC-01/21
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-06
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2021-002549-13
    A.3Full title of the trial
    A Randomised Double-Blind Placebo-Controlled Phase III Clinical
    Study to Evaluate the Efficacy and Safety of Cobitolimod as an
    Induction and Maintenance Therapy in Participants with Moderate
    to Severe Active Left-Sided Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    CONCLUDE
    A.4.1Sponsor's protocol code numberCSUC-01/21
    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 SponsorInDex Pharmaceuticals
    B.1.3.4CountrySweden
    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 supportInDex Pharmaceuticals
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarin
    B.5.2Functional name of contact pointArnesson
    B.5.3 Address:
    B.5.3.1Street AddressBerzelius väg 13
    B.5.3.2Town/ citySolna
    B.5.3.3Post code171 65
    B.5.3.4CountrySweden
    B.5.4Telephone number468112 038 50
    B.5.6E-mailkarin.arnesson@indexpharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/02/106
    D.3 Description of the IMP
    D.3.1Product nameCobitolimod
    D.3.4Pharmaceutical form Rectal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBITOLIMOD
    D.3.9.1CAS number 1527479-55-5
    D.3.9.4EV Substance CodeSUB189302
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/02/106
    D.3 Description of the IMP
    D.3.1Product nameCobitolimod
    D.3.4Pharmaceutical form Rectal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBITOLIMOD
    D.3.9.1CAS number 1527479-55-5
    D.3.9.4EV Substance CodeSUB189302
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboRectal solution
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe left-sided Active Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe left-sided Active Ulcerative Colitis
    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
    Primary Objective: Induction
    To evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC.
    Primary Objective: Maintenance
    To evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission, in participants with clinical response at I-week 6 after induction treatment with cobitolimod.
    E.2.2Secondary objectives of the trial
    Secondary Objectives: Induction
    • To evaluate the safety and tolerability of cobitolimod compared to placebo.
    • To evaluate the efficacy of cobitolimod treatment compared to placebo in clinical symptoms, endoscopy and histology endpoints.
    • To evaluate the efficacy of cobitolimod treatment compared to placebo in other secondary endpoints.
    Secondary Objectives: Maintenance
    • To evaluate the safety and tolerability of cobitolimod compared to placebo.
    • To evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in
    clinical symptoms, endoscopy and histology endpoints.
    • To evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in other secondary endpoints.
    • To evaluate HRQoL and health economics
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria: Induction
    1. Male or female ≥ 18 years of age.
    2. Established diagnosis of UC, with minimum time from diagnosis of at least 3 months before screening visit 1b.
    3. Moderate to severe active left-sided UC (disease should extend 15 cm or more above the anal verge and not beyond the splenic flexure) determined by a 3-component Mayo score of 5 to 9 with an endoscopic subscore ≥2 (in sigmoid or descending segments) assessed by central reading of endoscopy, and with stool frequency and rectal bleeding subscores, assessed by eDiary, each ≥1.
    4. Have inadequate response, loss of response or be intolerant of at least one of the following treatments:
    a. Oral GCS
    b. AZA/6-MP
    c. Biologics, JAK-inhibitors, or other approved advanced therapies for UC
    5. Allowed to receive a therapeutic dose of the following UC drugs during the study:
    a. Oral GCS therapy (≤20 mg prednisone or equivalent/day) provided that the dose has been stable for 2 weeks prior to visit 1b, or oral Budesonide MMX® therapy (9 mg/day) initiated at least 8 weeks before visit 1b, provided that the dose has been stable for 2 weeks prior to visit 1b.
    b. Oral 5-ASA/SP compounds, provided that the dose has been stable for 2 weeks prior to visit 1b and initiated at least 8 weeks before visit 1b.
    c. AZA/6-MP provided that the dose has been stable for 8 weeks prior to visit 1b and initiated at least 3 months before visit 1b.
    6. Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.

    Inclusion Criteria: Maintenance
    Participants are eligible to be included in the maintenance study if they have achieved clinical response at I-week 6 and have adhered to the protocol procedures of the induction study.
    Clinical response is defined by a decrease in the 3-component Mayo score (rectal bleeding, stool frequency, and endoscopy) of at least two (2) points and at least 35% from I-week 0 with either a decrease in the rectal bleeding subscore of at least one (1) point or a rectal bleeding subscore of 0 or 1.
    E.4Principal exclusion criteria
    Exclusion Criteria: Induction
    1. Suspicion of differential diagnosis such as Crohn’s enterocolitis, ischaemic colitis, radiation colitis, indeterminate colitis, infectious colitis, diverticular disease, associated colitis, microscopic colitis, massive pseudopolyposis or non-passable stenosis.
    2. Acute fulminant UC, toxic megacolon and/or signs of systemic toxicity.
    3. UC limited to the rectum (disease extending <15 cm above the anal verge) or extending beyond the splenic flexure.
    4. Have failed treatment with more than three advanced therapies (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab or tofacitinib) of two different therapeutic classes (anti-TNF, anti-integrins, anti-IL12/23, JAKinhibitors, or other approved advanced therapies for UC).
    5. Have had surgery for treatment of UC.
    6. History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured) or treated (cured) basal cell or squamous cell in situ carcinoma.
    7. History or presence of any clinically significant disorder that, in the opinion of the investigator, could impact on the participant’s ability to adhere to the protocol and protocol procedures, or would confound the study result or compromise participant safety.
    8. Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies such as infliximab, adalimumab, golimumab, vedolizumab, ustekinumab or tofacitinib, or similar immunosuppressants and immunomodulators at enrolment.
    Any prior treatment with such drugs must have been discontinued at least 8 weeks prior to visit 1b (except for ustekinumab, which must have been discontinued at least 12 weeks prior to visit 1 b) or have non-measurable serum concentration levels.
    9. Treatment with rectal GCS, 5-ASA/SP or tacrolimus within 2 weeks before visit 1b.
    10. Long-term treatment (>14 days) with antibiotics or NSAIDs within 2 weeks prior to visit 1b (one short treatment regimen for antibiotics, occasional use of NSAIDs and low dose NSAIDs as prophylactic therapy is allowed).
    11. Serious known active infection including history of latent or active
    tuberculosis, documented history of past or current tuberculosis, or living with or having frequent close contact with people with active tuberculosis or with a positive tuberculosis test according to current regulations for 12 weeks preceding randomisation. Serious infections include, but is not limited to, HIV, HBV, or HCV infections.
    12. Gastrointestinal infections including positive Clostridium difficile stool assay. (Local laboratory reports must be available in accordance with normal clinic practice, to confirm that the current episode of disease exacerbation is not due to infection).
    13. Females who are lactating or have a positive serum pregnancy test during the screening period.
    14. Women of childbearing potential not using highly effective (failure rate < 1%) contraceptive methods throughout the duration of the study.
    15. Concurrent participation in another clinical study with investigational therapy or previous use of investigational therapy within 5 half-lives and within at least 30 days after last treatment of the experimental product prior to enrolment.
    16. Previous exposure to cobitolimod

    Exclusion Criteria Maintenance:
    Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint: Induction
    Proportion of participants with clinical remission at I-week 6, defined by the 3-component Mayo score, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one (1) point decrease from I-week 0 if 1 at I-week 0), and iii) endoscopic score of 0 or 1

    Primary Endpoints: Maintenance
    Primary Efficacy
    Proportion of participants with clinical remission at M-week 45, defined by the 3-component Mayo score, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one (1) point decrease from I-week 0 if 1 at I-week 0), and iii) endoscopic score of 0 or 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint primary endpoint Induction:
    Induction week 6
    Timepoint primary endpoint Maintenance:
    Maintenance week 45
    E.5.2Secondary end point(s)
    Secondary Endpoints: Induction
    Safety:
    • incidence of AEs
    • incidence of SAEs
    • vital signs
    • physical examination
    • laboratory findings
    Key Secondary Efficacy:
    • Proportion of participants with endoscopic
    improvement at I-week 6.
    • Proportion of participants with symptomatic
    remission at I-week 6.
    Other Secondary Efficacy:
    • Proportion of participants with clinical response at I-week 6.
    • Proportion of participants with normalisation of stool frequency at I-week 6.
    • Proportion of participants with absence of rectal bleeding at I-week 6.
    • Mean stool frequency at I-week 6.
    • Proportion of participants with histologic improvement at I-week 6
    Proportion of participants with histologic remission at I-week 6.
    • Proportion of participants with mucosal healing at I-week 6
    • Mean ln-transformed faecal calprotectin at I-week 6.
    • Mean 3-component and 4-component Mayo scores at I-week 6
    • Mean IBDQ total score at I-week 6.
    • Proportion of participants with an improvement in IBDQ total score at I-week 6 compared to I-week 0.

    Secondary Endpoints: Maintenance
    Safety
    • incidence of AEs
    • incidence of SAEs
    • vital signs
    • physical examination
    • laboratory findings
    Key Secondary Efficacy:
    • Proportion of participants with endoscopic improvement at M-week 45.
    • Proportion of participants with clinical remission at M-week 45 and steroid-free for at least 8 weeks prior.
    • Proportion of participants with clinical remission at M-week 45 among those who achieved clinical
    remission at I-week 6.
    • Proportion of participants with symptomatic remission at M-week 45.
    Other Secondary Efficacy:
    • Proportion of participants with histologic improvement at M-week 45.
    • Proportion of participants with histologic remission at M-week 45.
    • Proportion of participants with mucosal healing at M-week 45.
    • Proportion of participants with clinical response at M-week 45
    • Proportion of participants with absence of rectal bleeding at M-week 45.
    • Proportion of participants with normalisation of stool frequency at M-week 45.
    • Mean stool frequency at M-week 45.
    • Mean ln-transformed faecal calprotectin at Mweek 45.
    • Mean 3-component and 4-component Mayo scores at M-week 45.
    • Mean IBDQ total score at M-week 45.
    • Proportion of participants with an improvement in IBDQ total score at M-week 45 compared to I-week 0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time point secondary endpoint induction:
    Key secondary efficacy Induction-week 6
    Other secondary efficacy Induction-week 6
    Time point secondary endpoint maintenance:
    Key secondary efficacy maintenance-week 45
    Other secondary efficacy Maintenance-week 45
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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
    Australia
    Bosnia and Herzegovina
    Brazil
    Canada
    Colombia
    Georgia
    Israel
    Korea, Democratic People's Republic of
    Mexico
    New Zealand
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Denmark
    France
    Germany
    Hungary
    Italy
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    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 months7
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 440
    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 Decision2021-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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