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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT05181137
• Date of registration: 10/12/2021
• Prospective Registration: No
• Primary sponsor: Reistone Biopharma Company Limited
• Public title: A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis
• Scientific title: A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: November 5, 2021
• Target sample size: 368
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05181137
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China, Georgia, Poland, Ukraine, United States

Contacts

• Name: Xiang Chen
• Affiliation: Reistone Pharma

• Name: Minna Sun

Key inclusion & exclusion criteria

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,


Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo

Drug: SHR0302

Primary Outcome(s)

Clinical remission at week 8 (Part 1) [Time Frame: 8 weeks]

Clinical remission at week 52 (Part 2) [Time Frame: 52 weeks]

Secondary Outcome(s)

Change from baseline in Partial Mayo score at week E2, E12, and E26 (Part 3) [Time Frame: 26 weeks (extension)]

Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52 (Part 2) [Time Frame: 52 weeks]

Subjects in clinical remission per partial Mayo score at week E26 (Part 3) [Time Frame: 26 weeks (extension)]

Subjects in corticosteroid-free remission per Partial Mayo score at week E26 (Part 3) [Time Frame: 26 weeks (extension)]

Subjects with endoscopic remission (Part 2) [Time Frame: 52 weeks]

Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1) [Time Frame: 8 weeks]

Clinical response at week 8 (Part 1) [Time Frame: 8 weeks]

Change in total Mayo score and 9-point modified Mayo score at week 52 (Part 2) [Time Frame: 52 weeks]

Endoscopic remission at week 8 (Part 1) [Time Frame: 8 weeks]

Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1) [Time Frame: 8 weeks]

Subjects in corticosteroid-free remission at week 52 (Part 2) [Time Frame: 52 weeks]

Subjects with clinical response at week 52 (Part 2) [Time Frame: 52 weeks]

Subjects who maintain clinical remission at week 52 (Part 2) [Time Frame: 52 weeks]

Secondary ID(s)

RSJ10135

Source(s) of Monetary Support

Please refer to primary and secondary sponsors