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

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT05181137

Run by

Reistone Biopharma Company Limited

People needed

368

Starts

2021-11-05

Expected to finish

2025-03-31

Last updated by the study team

2023-09-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria for Part 1
• Male or female subjects must be at least at ≥18 and ≤75 years of age
• Subject has at least a three-month history of Ulcerative Colitis diagnosis at baseline.
• Subject has active Ulcerative Colitis with a 9-point modified Mayo score of ≥ 5 at baseline, with an endoscopic subscore of ≥ 2
• 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
• 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

You may not qualify if…

• Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn'sDisease.
• Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
• 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).
• Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
• Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
• 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.
• Subject currently has or has a history of active tuberculosis (TB) or latent TB infection.
• 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.
• 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.
• Subject has previously received JAK inhibitors, such as tofacitinib, baricitinib, upadacitinib, filgotinib.
• Subject with evidence of clinically relevant laboratory abnormalities which may affect subject safety or interpretation of study results at screening
• Subject has a screening 12-lead ECG that demonstrates clinically relevant abnormalities
• 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.
• Subject has current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline.
• Subject with a first-degree relative with a hereditary immunodeficiency.
• 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.
• 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.

Where it is running

• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Xiangya Hospital Central South University — Changsha, Hunan, China (enrolling)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, Hena, China (enrolling)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Jingzhou First People's Hospital — Jingzhou, Hubei, China (enrolling)
• Affiliated Taihe Hospital of Hubei University of Medicine — Shiyan, Hubei, China (enrolling)
• Anhui Provincial Hospital — Hefei, Anhui, China (enrolling)
• Beijing Military Area General Hospital/Seventh Medical Center of PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)
• Army Medical Center of PLA — Chongqing, Chongqing Municipality, China (enrolling)
• Chongqing People's Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• The First Affiliated Hospitial of Xiamen University — Xiamen, Fujian, China (enrolling)
• Guangzhou First People's Hospital — Guangzhou, Guangdong, China (enrolling)
• The Sixth Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)
• Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Henan University of Science and Technoloy — Luoyang, Henan, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (enrolling)
• Zhuzhou Central Hospital — Zhuzhou, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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