SHR0302 for Ulcerative Colitis

Not currently recruiting at 72 trial locations

Overseen By Xiaojun Zhou

Age: 18+

Sex: Any

Trial Phase: Phase 3

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) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, SHR0302 (also known as Ivarmacitinib), for individuals with moderately to severely active ulcerative colitis, a condition where the colon becomes inflamed, causing symptoms like frequent diarrhea and abdominal pain. The study compares SHR0302 to a placebo (a pill with no active medicine) to determine its effectiveness in managing these symptoms. Participants should have had ulcerative colitis for at least three months and must not have responded well to previous treatments. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that SHR0302, also known as ivarmacitinib, is being tested for treating ulcerative colitis. In earlier studies, most patients tolerated SHR0302 well. For example, one study found that 89% of patients completed the full 8-week treatment. Some side effects occurred, but they were usually mild to moderate. This suggests that SHR0302 is generally safe, though individual experiences may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Researchers are excited about SHR0302 for ulcerative colitis because it offers a new way to manage the disease. Most current treatments, like aminosalicylates, corticosteroids, and biologics, work by suppressing the immune system broadly. SHR0302, on the other hand, targets a specific pathway called the JAK/STAT pathway, which is involved in inflammation. This targeted approach could mean fewer side effects and more effective control of symptoms. Plus, SHR0302 is taken as an oral tablet, which is more convenient than some existing treatments that require injections or infusions.

What evidence suggests that SHR0302 might be an effective treatment for ulcerative colitis?

Research has shown that SHR0302, also known as Ivarmacitinib, effectively treats moderate-to-severe ulcerative colitis (UC). Studies found that this treatment worked well and was safe for patients with active UC. SHR0302 is a JAK1 inhibitor, blocking a specific process that causes inflammation, thereby reducing inflammation and symptoms in UC patients. Early trials showed promising results, suggesting that SHR0302 could be a helpful treatment for those dealing with this condition. Participants in this trial will receive either SHR0302 or a placebo, allowing researchers to further evaluate its effectiveness and safety. ^{1 4 6 7 8}

Who Is on the Research Team?

Xiang Chen

Principal Investigator

Reistone Pharma

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SHR0302

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Reistone Biopharma Company Limited

Lead Sponsor

Trials

11

Recruited

2,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35963369/

Efficacy and Safety of Ivarmacitinib in Patients With ... Ivarmacitinib demonstrated clinical efficacy and was well tolerated in patients with moderate-to-severe, active, UC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03675477

NCT03675477 | A Phase II Study in Patients With Moderate ... The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients. This is an 8+8 weeks ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(22)00918-0/fulltext

Efficacy and Safety of Ivarmacitinib in Patients With ... Efficacy and Safety of Ivarmacitinib in Patients With Moderate-to-Severe, Active, Ulcerative Colitis: A Phase II Study. Baili Chen.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05181137/a-phase-3-study-to-investigate-the-efficacy-and-safety-of-shr0302-with-moderately-to-severely-active-ulcerative-colitis

A Phase 3 Study to Investigate the Efficacy and Safety of ... A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis. Last updated: August ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508522009180

Efficacy and Safety of Ivarmacitinib in Patients With ... Ivarmacitinib, a selective JAK1 inhibitor, was well tolerated and demonstrated promising signs of efficacy in adult patients with moderate-to-severe, active UC.

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/315215

A Phase 3 Study to Investigate the Efficacy and Safety of ... 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 ...

7. researchgate.net researchgate.net/publication/362616693_Efficacy_and_Safety_of_Ivarmacitinib_in_Patients_with_Moderate-to-Severe_Active_Ulcerative_Colitis_A_Phase_II_Study

Efficacy and Safety of Ivarmacitinib in Patients With ... Ivarmacitinib, a selective JAK1 inhibitor previously known as SHR0302, has been shown to be efficacious and well tolerated in ulcerative colitis in a randomized ...

8. go.drugbank.com go.drugbank.com/drugs/DB16756

Ivarmacitinib: Uses, Interactions, Mechanism of Action Ivarmacitinib is a selective JAK1 inhibitor under investigation for the treatment of immuno-inflammatory diseases.