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A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis

Recruiting
18 - 75 years of age
Both
Phase 3

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Overview

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.

Description

This study consists of a screening period followed by a placebo-controlled Part 1 phase and then a placebo-controlled Part 2 phase. An open label Part 3 phase is open to subjects who: complete the Part 2, are considered non-responders following the Part 1, or have disease worsening during Part 2.

Eligibility

Inclusion Criteria:

Inclusion Criteria for Part 1

  1. Male or female subjects must be at least at ≥18 and ≤75 years of age
  2. Subject has at least a three-month history of Ulcerative Colitis diagnosis at baseline.
  3. Subject has active Ulcerative Colitis with a 9-point modified Mayo score of ≥ 5 at baseline, with an endoscopic subscore of ≥ 2
  4. Subject is deemed by the physician as having inadequate response, loss of response or intolerance 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.
        Inclusion Criteria for Part 2 1. Subject has completed Part 1 and achieved clinical
        response at week 8
        Inclusion Criteria for Part 3
        1. Subject has completed the 8-week Part 1 and was classified as not meeting clinical
        response criteria. OR Subject has discontinued treatment early in the Maintenance phase due
        to disease worsening OR Subject has completed the Maintenance phase.
        Study Exclusion Criteria for Part 1
        Exclusion Criteria:
          1. Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of
             Crohn'sDisease.
          2. Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or
             less).
          3. Treatment naïve subject diagnosed with Ulcerative Colitis (without previous exposure
             to any of the following therapies for UC treatment: oral 5-ASA, corticosteroids,
             immunosuppressants, or biological treatments).
          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 has a history of active tuberculosis (TB) or latent TB
             infection.
          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 (such as
             CamPath® [alemtuzumab], alkylating agents [e.g., cyclophosphamide or chlorambucil],
             total lymphoid irradiation, etc.). 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 laboratory abnormalities which may affect
             subject safety or interpretation of study results at screening
         12. Subject has a screening 12-lead ECG that demonstrates clinically relevant
             abnormalities
         13. Subject currently has or had:
               -  A clinically significant infection within 1 month of baseline (e.g., those
                  requiring hospitalization or parenteral antimicrobial therapy or have
                  opportunistic infections).
               -  A history of more than one episode of herpes zoster, or disseminated zoster
                  (single episode).
               -  Any infection otherwise judged 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 (such as EBV-related
             lymphoproliferative disorder, as reported in some subjects on other immunosuppressive
             drugs), 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 e.g., gastrectomy,
             or clinically significant diabetic gastroenteropathy, or certain types of bariatric
             surgery such as gastric bypass. (Procedures such as gastric banding, gastric balloon
             that simply divide stomach into separate chambers, are NOT exclusionary.) Subject has
             undergone significant trauma or major surgery within 4 weeks of baseline.
         18. Women who are pregnant or lactating, or planning pregnancy while enrolled in the
             study. Male who plan to donate sperm during the study and within 30 days after the
             last dose of study drug.
         19. Subject who has a history of alcohol or drug abuse with less than 6 months of
             abstinence prior to baseline that in the opinion of the investigator will preclude
             participation in the study.
         20. Subject with malignancies or with a history of malignancies with exception of
             adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
             skin.
         21. Subject infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
         22. Subject has received any investigational drug or device within 3 months, or 5
             half-lives (if known) prior to baseline.
         23. Subject is receiving or expected to receive prohibited concomitant medication(s) in
             the 4 weeks prior to the first dose of study drug and through follow-up visit.
         24. Any other condition which in the opinion of the investigator would make the subject
             unsuitable for inclusion in the study.
         25. Subject with historical or current evidence of clinically significant cardiovascular,
             neurological, psychiatric, renal, hepatic, immunological, gastrointestinal,
             urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including
             uncontrolled diabetes or thyroid disease), or hematological abnormalities that are
             uncontrolled. Significant is defined as any disease that, in the opinion of the
             Investigator, would put the safety of the subject at risk through participation, or
             which would affect the efficacy or safety analysis if the disease/condition
             exacerbated during the study.
         26. Subject with a history of thromboembolic events, including deep vein thromboses (DVT),
             pulmonary embolism (PE), and those with known inherited conditions that predispose to
             hypercoagulability.
        Study Exclusion Criteria for Parts 2 and 3
          1. Subject with any clinically significant condition at the end of 8-week Induction
             treatment from Part 1 Induction phase, and Part 2 Maintenance 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.

Study details

Ulcerative Colitis

NCT05181137

Reistone Biopharma Company Limited

26 January 2024

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