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    Summary
    EudraCT Number:2018-003303-19
    Sponsor's Protocol Code Number:RSJ10201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-23
    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 number2018-003303-19
    A.3Full title of the trial
    A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease.
    A.4.1Sponsor's protocol code numberRSJ10201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03677648
    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 AddressRoom 402-05, Building 1, Zhangjiang High-tech Park, 800 Naxian Road
    B.5.3.2Town/ cityPudong, Shanghai
    B.5.3.3Post code201210
    B.5.3.4CountryChina
    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.3.2Product 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 INNPending
    D.3.9.1CAS number 1639419-51-4
    D.3.9.2Current sponsor codeSHR0302
    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
    Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease
    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 PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    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 evaluate the efficacy of SHR0302 compared to placebo in inducing clinical remission at Week 12.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of oral SHR0302
    • To evaluate the efficacy of oral SHR0302 in inducing clinical remission at different time points
    • To evaluate the efficacy of oral SHR0302 in inducing endoscopy response
    • To evaluate the change from baseline in the following biomarkers; CRP, fecal calprotectin.
    • To characterise the pharmacokinetics of oral SHR0302 and explore the correlation of exposure-response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or Female age ≥ 18 and ≤75 years of age at randomization.
    • Subjects with a documented at least three-month history of diagnosed ileal, colonic, or ileocolonic Crohn’s Disease at the time of randomization.
    • Currently having Crohn’s Disease with Crohn’s Disease Activity Index (CDAI) score ≥ 220 to ≤450.
    E.4Principal exclusion criteria
    • Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
    • Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
    • Treatment naïve subjects diagnosed with Crohn’s disease (without previous exposure to any of the following therapies for CD treatment: 5-
    ASA, corticosteroids, immune-suppressants, or biological treatment).
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of subjects achieving clinical remission at week 12, defined as Crohn’s Disease Activity Index (CDAI) score < 150.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    - The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.

    - The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.

    - The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 70 points at Week1, 4, 8, 12, 13, 16, and 24.

    - The percentage of subjects achieving clinical remission, defined as CDAI of < 150 points at Week 1, 4, 8, 13, 16 and 24.

    - Change from baseline in CDAI at Week1, 4, 8, 12, 13, 16 and 24.

    - The percentage of subjects achieving endoscopic remission defined as Simple Endoscopy Score for Crohn’s Disease (SES-CD) score ≤ 4, with “ulcerated surface” subscore no greater than 1 in any segment at Week 12.
    - The percentage of subjects achieving endoscopic remission defined as
    Simple Endoscopy Score for Crohn's Disease (SES-CD) score of 0-2 or
    SES-CD score ≤ 4 and at least 2-point reduction from baseline with no
    subscore >1 at Week 12.
    - The percentage of subjects achieving endoscopic response at Week 12, defined as a reduction of Simple Endoscopy Score for Crohn's Disease (SES-CD) score by at least 50% from baseline.

    - The percentage of subjects achieving mucosal healing as defined by a Simple Endoscopy Score for Crohn's Disease (SES-CD) score equal to 0 at Week 12.

    - The Change from baseline in endoscopic Simple Endoscopy Score for Crohn's Disease (SES-CD) score at Week 12.

    - Change from baseline in the level of biomarkers CRP, fecal calprotectin.

    - The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.

    - The systemic exposure of SHR0302 in steady state (i.e. concentration and area under the curve).

    Safety Endpoints
    • To evaluate the safety and tolerability by laboratory parameters.
    • To evaluate the safety and tolerability by collection of AE/SAE incidence
    • To measure the vital signs (BP, HR, and Body temperature)
    • To measure total lipid profile, which includes Triglyceride, LDL and HDL.
    • To measure thyroid profile; TSH, free T4 and free T3.
    • 12 –lead ECG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 (unless otherwise noted above)
    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 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 trial4
    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 concerned19
    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
    Poland
    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
    Th end of the trial is defined as the date of the last subject’s last visit or the actual date of follow up visit/contact, whichever is later.
    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 months6
    E.8.9.1In the Member State concerned days8
    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 days14
    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: 137
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 144
    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 Decision2019-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-09
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