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    Summary
    EudraCT Number:2021-001940-86
    Sponsor's Protocol Code Number:RSJ10135
    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:2021-08-09
    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 number2021-001940-86
    A.3Full title of the trial
    A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 for Induction, Maintenance Therapy 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 phase 3 Study to Evaluate the Efficacy and Safety of SHR0302 in Ulcerative Colitis.
    A.4.1Sponsor's protocol code numberRSJ10135
    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 SponsorReistone Biopharma Company Limited
    B.1.3.4CountryChina
    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 supportReistone Biopharma Company Limited
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReistone Biopharma Company Limited
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address298 Xiangke Road, 2/F, Room 201,203, Zhangjiang Hi-Tech Park,
    B.5.3.2Town/ cityPudong, Shanghai
    B.5.3.3Post code201210
    B.5.3.4CountryChina
    B.5.4Telephone number0086 0 21 6881 5767
    B.5.5Fax number00 86 021 6881 3055
    B.5.6E-mailhaifeng.cao@reistonebio.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 nameSHR0302 tablets
    D.3.2Product code SHR0302
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSHR0302
    D.3.9.1CAS number 1639419-51-4
    D.3.9.4EV Substance CodeSUB196516
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboFilm-coated tablet
    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
    Moderately to severely active Ulcerative Colitis (UC)
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis (UC)
    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
    Part 1 Induction phase: to evaluate the efficacy of SHR0302 8 mg QD, compared to placebo in inducing clinical remission in adult subjects with moderately to severely active ulcerative colitis at week 8.
    Part 2 Maintenance phase: to evaluate the efficacy of SHR0302 4 mg QD compared to placebo as maintenance treatment in maintaining clinical remission in adult subjects with moderately to severely active ulcerative colitis at week 52.
    Part 3 Open-Label Extension phase: to evaluate the long-term safety of SHR0302 4 mg QD in adult subjects with moderately to severely active ulcerative colitis
    E.2.2Secondary objectives of the trial
    Part 1
    To evaluate the efficacy of SHR0302 in achieving endoscopic remission in subjects with moderately to severely active ulcerative colitis (UC).
    To evaluate the efficacy of SHR0302 as induction therapy on clinical response in subjects with moderately to severely active UC.
    To characterize the PK of SHR0302 in moderately to severely active UC and explore the correlation of exposure-response.
    To evaluate the safety and tolerability of SHR0302 in subjects with moderately to severely active UC.
    Part 2
    To evaluate the efficacy of SHR0302 in endoscopic remission in subjects with moderately to severely active UC.
    To evaluate the efficacy of SHR0302 as maintenance therapy on clinical response in subjects with moderately to severely active UC.
    To evaluate the safety and tolerability of SHR0302 in subjects with moderately to severely active UC.
    Part 3
    To evaluate the efficacy of SHR0302 in Partial Mayo score remission in subjects with moderately to severely active UC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Part 1 Induction phase
    1. Male and female subjects age ≥18 and ≤75 years of age at baseline.
    2. Subject has active ulcerative colitis with a 9-point modified Mayo score of ≥5, with an endoscopic subscore of ≥2 (confirmed by central read) prior to 14 days of baseline visit. (Note: endoscopy should be performed within 14 days prior to baseline visit).
    3. Subject has at least a three-month history of ulcerative colitis diagnosis at baseline.
    4. Subject is deemed by the investigator as having an inadequate response, loss of response or intolerance (see appendix 5) to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or was previously exposed to anti-TNF therapy (e.g. infliximab, adalimumab), or other biological treatment (e.g., vedolizumab) having discontinued the treatment for:
    - Infliximab: a minimum of 8 weeks prior to baseline.
    - Adalimumab: a minimum of 10 weeks prior to baseline.
    - Ustekinumab: a minimum of 14 weeks prior to baseline.
    - Vedolizumab: a minimum of 17 weeks prior to baseline.
    For other biological treatments, subject should have discontinued for a minimum of 5 half-lives prior to baseline.
    5. If subject is currently receiving the following “background” treatment for UC, they are eligible for the study, provided they are on a stable dose for the required period:
    - Oral 5 ASA or sulfasalazine, stable dose for at least 2 weeks prior to baseline and during the study treatment period.
    AND/OR
    - Oral corticosteroids (prednisolone≤30mg/day or less or equivalent) stable dose for at least 2 weeks prior to baseline. This is not applicable to the subjects who have only been exposed to 5-ASA previously as per inclusion criteria 4 (e.g., subjects who have only been exposed to 5-ASA previously, to initiate an oral corticosteroid before baseline is not permitted).
    6. All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from signing of informed consent, throughout the duration of the study, and for 1 month after last dose of study medication: (refer to Section 4.3 for further details on contraception requirements for this study)
    - Male subjects who have a female partner of childbearing potential must be willing to use condom in addition to a highly effective contraceptive method.
    7. Subject is willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedures.
    8. Subject is capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspects of the study.
    Inclusion Criteria for Part 2 Maintenance phase
    1. Subject has completed part 1 induction phase and achieved clinical response at week 8.
    2. Women of childbearing potential must have negative urine pregnancy test prior to starting Part 2 Maintenance phase.
    Inclusion Criteria for Part 3 Open-Label Extension phase
    1. Subject has completed the 8-week induction treatment phase and was classified as not meeting clinical response criteria. Or
    Subject has discontinued treatment early in the maintenance phase due to disease worsening per protocol definition stated in Appendix 1. Or
    Subject has completed the maintenance phase.
    2. Women of childbearing potential must have a negative urine pregnancy test prior to starting Part 3 Open-Label Extension phase.

    E.4Principal exclusion criteria
    Exclusion criteria for Part 1 Induction phase
    1. Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn’s disease.
    2. Subject with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
    3. Treatment naïve subject diagnosed with ulcerative colitis.
    4. Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
    5. Subject had previous surgery as a treatment for ulcerative colitis or likely to require surgery during the study period.
    6. Subject has evidence of pathogenic bowel infection. Subjects had Clostridium difficile or other intestinal infection within 30 days of screening endoscopy or test positive at screening for C. difficile toxin or other intestinal pathogens.
    7. Subject currently has or had a history of active tuberculosis (TB) or latent TB infection, defined as:
    - A positive Mantoux Purified Protein Derivative (PPD) skin test result (> 5 mm of induration), or positive QuantiFERON TB Gold (QFT Gold test), or T-Spot test.
    8. Subject is receiving any of the following therapies:
    - Azathioprine/6-mercaptopurine, methotrexate, thalidomide within 7 days prior to baseline.
    - Cyclosporine, mycophenolate, tacrolimus within 4 weeks prior to baseline.
    - Interferon therapy within 8 weeks prior to baseline.
    - Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5-ASA within 2 weeks prior to baseline.
    9. Subject had any prior treatment with lymphocyte-depleting agents/therapies. Subjects who have received rituximab or other selective B lymphocyte depleting agents are eligible if they have not received such therapy for at least 1 year prior to baseline.
    10. Subject has previously received JAK inhibitors, such as tofacitinib, baricitinib, upadacitinib, filgotinib.
    11. Subject with evidence of clinically relevant abnormalities which may affect subject safety or interpretation of study results at screening:
    Hemoglobin levels < 8.0 g/dL or hematocrit < 30%
    An absolute white blood cell (WBC) count of < 3.0 × 109 /L (<3000/mm3) or absolute neutrophil count (ANC) of < 1.2 × 109 /L (<1200/mm3).
    Thrombocytopenia, as defined by a platelet count < 100 × 109 /L (<100,000/mm3).
    Total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2×ULN.
    eGFR ≤ 50 ml/min based on Cockcroft-Gault calculation, or is currently undergoing regular hematodialysis.
    12. Subject has a screening 12-lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety if being enrolled into the study or interpretation of study results.
    13. Subject currently has or had:
    a clinically significant infection within 1 month of baseline
    a history of more than one episode of herpes zoster or disseminated zoster (single episode).
    any infection otherwise deemed by the investigator to have the potential for exacerbation by participation in the study.
    any infection requiring antimicrobial therapy within 2 weeks of screening.
    14. Subject has current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline.
    15. Subject with a first-degree relative with a hereditary immunodeficiency.
    16. Subject with a history of any lymphoproliferative disorder, history of lymphoma, leukemia, multiple myeloma, or signs and symptoms that are suggestive of current lymphatic disease.
    17. Subject has any condition possibly affecting oral drug absorption.
    18. Women who are pregnant or lactating, or planning pregnancy while enrolled in the study.
    19. Subject who has a history of alcohol or drug abuse
    20. Subject infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
    21. Subject is receiving or expected to receive prohibited concomitant medication(s).
    Exclusion criteria for Part 2 Maintenance phase
    1. Subject with any clinically significant condition at the end of 8-week induction treatment from Part 1 Induction phase, that in the opinion of investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis.
    2. Subject who, in the opinion of the investigator or sponsor, is unlikely to be cooperative or able to comply with study procedures, or any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion.
    Exclusion criteria for Part 3 Open-Label Extension phase
    1. Subject with any clinically significant condition from Part 1, and Part 2, that in the opinion of investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis.
    2. Subject who, in the opinion of the investigator or sponsor, is unlikely to be cooperative or able to comply with study procedures, or any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    - Part 1 Induction phase
    Percentage of subjects in clinical remission at week 8.
    - Part 2 Maintenance phase
    Percentage of subjects in clinical remission at week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Part 1 Induction phase at week 8.
    - Part 2 Maintenance phase at week 52
    E.5.2Secondary end point(s)
    Part 1
    - The percentage of subjects with endoscopic remission.
    - The percentage of subjects with clinical response.
    - Change from baseline in partial Mayo score.
    - Change in total Mayo score and 9-point modified Mayo score.
    Part 2
    - The percentage of subjects with endoscopic remission.
    - The percentage of subjects with clinical response.
    - Change from baseline in partial Mayo score.
    - Change in total Mayo score and 9-point modified Mayo score.
    - Percentage of subjects in corticosteroid-free remission. Corticosteroid-free is defined as the subjects who discontinue corticosteroid of at least 4 weeks prior to the visit.
    - Percentage of subjects who maintain clinical remission.
    Part 3
    - The percentage of subjects in clinical remission per partial Mayo score. Defined as: total Partial Mayo score ≤ 1.
    - The percentage of subjects in corticosteroid-free remission per Partial Mayo score.
    - Change from baseline in Partial Mayo score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1
    - at week 8.
    - at week 8.
    - at week 2, 4, and 8.
    - at week 8.
    Part 2
    - at week 52.
    - at week 52.
    - at week 12, 16, 24, 32, 40, and 52.
    - at week 52.
    - at week 52, corticosteroid-free is defined as the subjects who discontinue corticosteroid of at least 4 weeks prior to the visit.
    - at week 52.
    Part 3
    - at week E26.
    - at week E26.
    - at week E2, E12, and E26.
    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) 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 Yes
    E.8.1.7.1Other trial design description
    3 parts in the study, induction - blinded; maintenance - blinded, OLE - open
    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 concerned13
    E.8.5The trial involves multiple Member States No
    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
    China
    Georgia
    Ukraine
    United States
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 118
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 368
    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 Decision2021-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-19
    P. End of Trial
    P.End of Trial StatusOngoing
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