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    Summary
    EudraCT Number:2021-000091-11
    Sponsor's Protocol Code Number:PR200-102
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-000091-11
    A.3Full title of the trial
    A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of PRA023 in patients with Ulcerative Colitis
    A.4.1Sponsor's protocol code numberPR200-102
    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 SponsorPrometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportPrometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address3050 Science Park Road
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.6E-mailmm@prometheusbiosciences.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 namePRA023
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 2648504-55-4
    D.3.9.2Current sponsor codePRA023
    D.3.9.3Other descriptive namePRA023
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation and ulcers in the colon resulting in abdominal pain and bloody diarrhea.
    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 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
    1. To assess the safety and tolerability of PRA023 following 12-weeks of induction therapy
    2. To compare the efficacy of PRA023 vs placebo for induction of clinical remission at Week 12
    E.2.2Secondary objectives of the trial
    Compare the efficacy of PRA023 vs placebo for induction of:
    - endoscopic improvement
    - clinical response
    - symptomatic remission
    - histologic remission
    - histologic-endoscopic mucosal improvement
    - mucosal healing

    Compare the efficacy of PRA023 vs placebo for change in IBDQ

    Compare the efficacy of PRA023 vs placebo in subjects who are companion diagnostic positive (CDx+) for induction of:
    - clinical remission
    - endoscopic improvement
    - clinical response
    - histologic remission
    - histologic-endoscopic mucosal improvement
    - mucosal healing

    Compare the efficacy of PRA023 vs placebo in subjects who are CDx+ per alternative algorithm for induction of clinical remission at Week 12

    Compare the efficacy of PRA023 in CDx+ vs CDx negative (CDx-) subjects for induction of clinical remission at Week 12

    Compare the efficacy of PRA023 vs placebo in CDx+ subjects for change in IBDQ at Week 12
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Pharmacokinetic Sub-Study
    Date and Version: 14Jun2023, V5.0
    Objective: To better understand the PK of PRA023 in subjects with UC and to evaluate the PK of PRA023 at steady state
    E.3Principal inclusion criteria
    Subjects are required to meet the following criteria in order to be included in the study:
    - Male or female ≥18 years of age
    - Subjects must have had a diagnosis of UC at least 3 month before Randomization (confirmed by endoscopy + histology) to be eligible for study participation
    - Moderately to severely active UC
    - Subjects must have had insufficient response and/or intolerance to conventional therapy
    - For subjects who are women of childbearing potential (WOCBP) involved in any sexual intercourse that could lead to pregnancy, the subject has used two highly effective methods of contraception for at least 4 weeks prior to Day 1 and agrees to continue to use two highly effective methods of contraception until at least 12 weeks after the last dose of study drug
    - Male subjects must use, with their female partner of childbearing potential, two highly effective methods of contraception and refrain from sperm donation from screening to 12 weeks after the last dose of study drug
    - Subject must meet concomitant medication stabilization requirements, as applicable
    - Able to provide written informed consent and understand and comply with the requirements of the study
    E.4Principal exclusion criteria
    - WOCBP and men with WOCBP partner unwilling/ unable to use two highly effective methods of contraception
    - Women who are pregnant or breastfeeding
    - Women with a positive pregnancy test
    - Diagnosis of Crohn's disease or indeterminate colitis
    - UC limited to the rectum (<15 cm from anal verge)
    - Current evidence of fulminant colitis, toxic megacolon, or bowel perforation
    - Current or impending need for colostomy or ileostomy
    - Previous total proctocolectomy or partial colectomy
    - Surgical bowel resection within 3 months before screening
    - Concomitant primary sclerosing cholangitis (PSC)
    - Past or current evidence of colonic dysplasia that has not been completely removed
    - Scheduled or anticipate the need for surgery, except dermatologic procedures
    - History of clinically significant drug or alcohol abuse
    - Prior exposure to PRA023
    - Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness must not be enrolled into this study
    - Legal or mental incapacitation, or inability to understand and comply with the requirements of the study
    E.5 End points
    E.5.1Primary end point(s)
    1. The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values.
    2. The proportion of subjects in clinical remission at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    1. The proportion of subjects with endoscopic improvement at Week 12.
    2. The proportion of subjects in clinical response at Week 12.
    3. The proportion of CDx+ subjects in clinical remission.
    4. The proportion of subjects in symptomatic remission at Week 12.
    5. The proportion of subjects with histologic remission at Week 12.
    6. The proportion of subjects with histologic-endoscopic mucosal improvement at Week 12.
    7. The proportion of CDx+ subjects with endoscopic improvement at Week 12.
    8. The proportion of CDx+ subjects in clinical response at Week 12.
    9. The proportion of subjects with symptomatic remission treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    10. The proportion of CDx+ subjects with histologic remission at Week 12.
    11. The proportion of CDx+ subjects with histologic-endoscopic mucosal improvement at Week 12.
    12. The proportion of CDx+ subjects with clinical remission Week 12.
    13. The proportion of subjects with mucosal healing at Week 12.
    14. The proportion of CDx+ subjects with mucosal healing at Week 12.
    15. The proportion of subjects with IBDQ response at Week 12.
    16. The proportion of CDx+ subjects with IBDQ response at Week 12.
    17. The proportion of CDx+ subjects (per alternative algorithm) in clinical remission at Week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Canada
    Georgia
    United Kingdom
    United States
    Belgium
    Czechia
    France
    Hungary
    Italy
    Poland
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 146
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 183
    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)
    After participants have stopped taking study drug, they will undergo 12 weeks of follow-up. The investigator will talk to them about how best to continue their medical care.
    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 Decision2021-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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