What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis, such as 5-aminosalicylates (e.g., mesalamine, sulfasalazine) and glucocorticoids, have various side effects. 5-ASA medications can cause nausea, headache, fever, rash, pancreatitis, and pneumonitis. Sulfasalazine, in particular, may also lead to gastrointestinal upset and reduced sperm count. Glucocorticoids, used for short-term relief, can result in systemic side effects like adrenal suppression, weight gain, hypertension, osteoporosis, and increased risk of infections. These side effects highlight the need for careful management and monitoring during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis that target inflammation. These include 5-aminosalicylates (5-ASA) like mesalamine and sulfasalazine, which are commonly used for mild to moderate UC. Biologic agents such as infliximab, adalimumab, and vedolizumab, which target specific components of the immune system, have also been approved for moderate to severe UC. Additionally, newer agents like ustekinumab, which targets interleukin-12 and interleukin-23, and tofacitinib, a Janus kinase inhibitor, have been approved for UC treatment. These therapies aim to reduce inflammation and maintain remission in UC patients.

What other types of research exist?

Promising novel alternatives to SPH3127 for ulcerative colitis patients in 2024 include anti-IL-23 agents (e.g., risankizumab), JAK inhibitors (e.g., tofacitinib, upadacitinib), anti-integrins (e.g., vedolizumab), and S1P modulators. These therapies are in advanced stages of clinical trials or have been recently approved, showing potential in addressing inflammation in ulcerative colitis.

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SPH3127 for Ulcerative Colitis

Q: What is the mechanism of action of this treatment?

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylates (5-ASAs), corticosteroids, immunomodulators, and biologics. 5-ASAs, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory mediators. Corticosteroids, like prednisone, suppress the immune response to decrease inflammation rapidly. Immunomodulators, such as azathioprine, alter the immune system to prevent chronic inflammation. Biologics, including anti-TNF agents like infliximab, target specific components of the immune system to block inflammation pathways. Emerging therapies, such as SPH3127, likely focus on novel mechanisms to reduce inflammation more effectively or with fewer side effects. Understanding these mechanisms is crucial for UC patients as it helps tailor treatment plans to achieve better disease control and improve quality of life.

Phase 2

Recruiting

Research Sponsored by Shanghai Pharma Biotherapeutics USA Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult males and females ≥ 18 to < 70 years of age on the day of signing the ICF

Female patients with negative pregnancy test at Screening and agree to use adequate birth control methods

Must not have

Significant blood loss or recent transfusion

Serious underlying diseases other than UC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening (baseline) to day 336 (optional additional 10 months active treatment extension)

Summary

This trial tests a new medication called SPH3127 for people with mild-to-moderate ulcerative colitis. The goal is to see if taking this medication by mouth can safely reduce their symptoms.

Who is the study for?

Adults aged 18-70 with mild-to-moderate ulcerative colitis extending at least 15 cm from the anal verge, who are not pregnant or abusing drugs/alcohol, and agree to use birth control. Excluded are those with certain infections, organ dysfunction, recent blood donations/transfusions, other trial participation within 30 days or specific medication use prior to the study.

What is being tested?

The trial is testing SPH3127's safety and effectiveness against a placebo in treating ulcerative colitis. Participants will be randomly assigned to receive either SPH3127 or a placebo without knowing which one they're getting (double-blind).

What are the potential side effects?

While specific side effects of SPH3127 aren't listed here, common ones for ulcerative colitis treatments may include headache, nausea, abdominal pain, fatigue. Since it's a trial drug potential side effects could vary widely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am not pregnant and agree to use birth control during the study.

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My ulcerative colitis is active and affects areas at least 15 cm from the anal verge.

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My drug test results were negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had significant blood loss or a recent transfusion.

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I do not have serious diseases other than ulcerative colitis.

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My kidney function is reduced.

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I am not on medications known to harm organs.

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I do not have any active infections.

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I have a known immune system disorder.

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I have liver problems or a history of liver cirrhosis.

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I have been diagnosed with severe ulcerative colitis.

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I have had cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening (baseline) to day 336 (optional additional 10 months active treatment extension)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening (baseline) to day 336 (optional additional 10 months active treatment extension)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (baseline) to day 336 (optional additional 10 months active treatment extension) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in Modified Mayo Clinical Score (MMCS)

Secondary study objectives

Change from baseline in Robarts Histopathology Index (RHI)

Change from baseline in UC-100 score

Change from baseline in fecal calprotectin

+1 more

Other study objectives

Mean plasma AUC0-8h of SPH4336

Mean plasma Cmax of SPH4336

Trial Design

3Treatment groups

Experimental Treatment

Group I: SPH3127 50 mgExperimental Treatment1 Intervention

1 50 mg SPH3127 tablet in the morning and 1 placebo tablet in the evening daily for 8 weeks. After 8 weeks, optional continuation of daily treatment for an additional 10 months.

Group II: SPH3127 100 mgExperimental Treatment1 Intervention

1 50 mg SPH3127 tablet in the morning and 1 50 mg SPH3127 tablet in the evening daily for 8 weeks. After 8 weeks, optional continuation of daily treatment for an additional 10 months.

Group III: PlaceboExperimental Treatment1 Intervention

2 placebo tablets, 1 in the morning and 1 in the evening, daily for 8 weeks. After 8 weeks, optional randomization to 1 of 2 SPH3127 daily treatment arms for an additional 10 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SPH3127

2022

Completed Phase 2

~60

Placebo

1995

Completed Phase 3

~2670

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylates (5-ASAs), corticosteroids, immunomodulators, and biologics. 5-ASAs, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory mediators. Corticosteroids, like prednisone, suppress the immune response to decrease inflammation rapidly. Immunomodulators, such as azathioprine, alter the immune system to prevent chronic inflammation. Biologics, including anti-TNF agents like infliximab, target specific components of the immune system to block inflammation pathways. Emerging therapies, such as SPH3127, likely focus on novel mechanisms to reduce inflammation more effectively or with fewer side effects. Understanding these mechanisms is crucial for UC patients as it helps tailor treatment plans to achieve better disease control and improve quality of life.

Emerging Therapies for Inflammatory Bowel Diseases.