SHR0302 for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+69 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Reistone Biopharma Company Limited

Must not be taking: JAK inhibitors, Azathioprine, Cyclosporine, others

Disqualifiers: Crohn's disease, Active TB, HIV, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting. For example, you must stop taking infliximab at least 8 weeks before, adalimumab 10 weeks before, ustekinumab 14 weeks before, and vedolizumab 17 weeks before the trial begins. Other medications like azathioprine, methotrexate, and certain corticosteroids also have specific stop times before the trial.

Eligibility Criteria

Adults aged 18-75 with moderately to severely active Ulcerative Colitis can join this trial. They must have a history of the disease for at least three months and not responded well to conventional treatments or certain biological therapies. People who've had recent infections, surgery for Ulcerative Colitis, or are pregnant cannot participate.

Inclusion Criteria

I completed the first part of the study and saw improvement by week 8.

I've tried at least one standard treatment for my condition without success or could not tolerate it.

I finished or stopped the initial 8-week treatment due to my condition worsening or completed the maintenance phase.

Exclusion Criteria

My ulcerative colitis affects only the rectum or the last part of my colon.

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, 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

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, 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, 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, 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, Subject infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses, Subject has received any investigational drug or device within 3 months, or 5 half-lives (if known) prior to baseline, 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, Any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion in the study, 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, 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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1 Treatment

Participants receive SHR0302 or placebo for 8 weeks

8 weeks

Part 2 Treatment

Participants receive SHR0302 or placebo for 44 weeks

44 weeks

Part 3 Open-label Extension

Participants receive SHR0302 for 26 weeks in an open-label extension

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Placebo (Placebo)
• SHR0302 (Unknown)

Trial Overview The study is testing SHR0302 against a placebo in people with Ulcerative Colitis. It's a Phase 3 trial where participants are randomly assigned to either the test drug or placebo without knowing which one they're getting, ensuring that results are unbiased.

Participant Groups

Group I: Part 3 Active Experimental: SHR0302 Dose#2 Experimental Treatment 1 Intervention

SHR0302 Oral tablets taken once daily (QD) for 26 weeks

Group II: Part 2 Active Experimental: SHR0302 Dose#2 Experimental Treatment 1 Intervention

SHR0302 Oral tablets taken once daily (QD) for 44 weeks

Group III: Part 1 Active Experimental: SHR0302 Dose#1 Experimental Treatment 1 Intervention

SHR0302 Oral tablets taken once daily (QD) for 8 weeks SHR0302 Oral tablets taken once daily (QD)

Group IV: Part 2 Placebo Comparator: Placebo Placebo Group 1 Intervention

Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo

Group V: Part 1 Placebo Comparator: Placebo Placebo Group 1 Intervention

Placebo Oral tablets taken once daily (QD) for 8 weeks

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

IHS Health Kissimmee, FL

One Health Research Clinic Atlanta, LLC Norcross, GA

Who Is Running the Clinical Trial?

Reistone Biopharma Company Limited Lead Sponsor

References