3 Participants Needed

SPH3127 for Ulcerative Colitis

Recruiting at 15 trial locations
KW
LJ
DJ
Overseen ByDinah Jaunakais, MEd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications before joining the trial. Specifically, you cannot take oral mesalamine over 2.4 g/day, systemic or rectal steroids, certain immunomodulators, antibiotics, anti-diarrheals, and some blood pressure medications within a few weeks before starting the trial. Please consult with the trial team for specific guidance on your medications.

Is SPH3127 safe for humans?

The available research does not provide specific safety data for SPH3127 or its other names. However, a study on a similar treatment, IBD98-M, found it to be safe and well-tolerated in patients with ulcerative colitis, with no new or unexpected safety issues.12345

What makes the drug SPH3127 unique for treating ulcerative colitis?

SPH3127 is unique because it is being studied as a potential new treatment for ulcerative colitis, a condition with high placebo response rates in clinical trials, which complicates the evaluation of new therapies. The research highlights the importance of understanding placebo effects in trial design, but specific details about SPH3127's mechanism or administration are not provided in the available studies.13678

Who Is on the Research Team?

KW

Kenneth W. Locke, PhD

Principal Investigator

Shanghai Pharma Biotherapeutics USA Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a man and will use birth control with my partner who can have children.
I am not pregnant and agree to use birth control during the study.
Rectal bleeding subscore ≥ 1
See 6 more

Exclusion Criteria

Clinically relevant abnormalities detected on vital signs
I have not taken certain medications recently.
Positive stool sample for enteric pathogens
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral administration of SPH3127 or placebo for 8 weeks

8 weeks
Visits on Day 1, 28, and 56

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Active-treatment extension (optional)

Participants may opt into continuation of treatment with SPH3127 for an additional 10 months

10 months

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • SPH3127
Trial Overview 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).
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: SPH3127 50 mgExperimental Treatment1 Intervention
Group II: SPH3127 100 mgExperimental Treatment1 Intervention
Group III: PlaceboExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shanghai Pharma Biotherapeutics USA Inc.

Lead Sponsor

Trials
2
Recruited
40+

Published Research Related to This Trial

In a study of 287 patients with ulcerative proctitis and proctosigmoiditis, mesalamine enemas (1, 2, and 4 g) significantly improved symptoms and clinical outcomes compared to placebo, with 67% to 75% of patients showing marked improvement.
The safety profile of mesalamine enemas was comparable to that of placebo, indicating that they are a safe and effective treatment option for distal ulcerative colitis without a clear dose-response effect.
Dose-ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: results of a multicentered placebo-controlled trial. The U.S. PENTASA Enema Study Group.Hanauer, SB.[2019]
The newer formulations of 5-aminosalicylic acid (5-ASA) were found to be significantly more effective than placebo in inducing remission in active ulcerative colitis, with a pooled odds ratio of 0.51, indicating a lower failure rate in achieving clinical improvement.
While 5-ASA showed a trend towards better outcomes compared to sulfasalazine (SASP), the difference was not statistically significant, and 5-ASA was better tolerated, suggesting it may be a preferable option despite potential cost considerations.
Oral 5-aminosalicylic acid for inducing remission in ulcerative colitis.Sutherland, L., Roth, D., Beck, P., et al.[2018]
In a review of 119 clinical trials for ulcerative colitis, the placebo rates for clinical remission during induction trials were found to be 11%, while maintenance trials showed higher rates of 18%, indicating variability based on trial phase.
Factors such as prior biologic therapy exposure and the number of follow-up visits significantly influenced placebo response rates, which can help in designing more effective clinical trials.
Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis.Sedano, R., Hogan, M., Nguyen, TM., et al.[2023]

Citations

Dose-ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: results of a multicentered placebo-controlled trial. The U.S. PENTASA Enema Study Group. [2019]
Oral 5-aminosalicylic acid for inducing remission in ulcerative colitis. [2018]
Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis. [2023]
Oral 5-aminosalicylic acid for maintaining remission in ulcerative colitis. [2020]
A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis. [2021]
Sulfasalazine revisited: a meta-analysis of 5-aminosalicylic acid in the treatment of ulcerative colitis. [2019]
Predictors of Placebo Induction Response and Remission in Ulcerative Colitis. [2023]
A longitudinal model for the Mayo Clinical Score and its sub-components in patients with ulcerative colitis. [2022]
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