Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Shanghai Pharma Biotherapeutics USA Inc.
Must not be taking: Steroids, Immunosuppressants, Antihypertensives, others
Disqualifiers: Severe UC, Colectomy, Liver impairment, others
No Placebo Group
Prior Safety Data
Trial Summary
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.
12345What 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.
13678Eligibility Criteria
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 between 18 and 70 years old.
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.
+7 more
Exclusion Criteria
Clinically relevant abnormalities detected on vital signs
I have not taken certain medications recently.
Positive stool sample for enteric pathogens
+21 more
Trial Timeline
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
Participant Groups
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).
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Bayside Clinical Research LLCTrinity, FL
Clinical Research of West FloridaClearwater, FL
Clinical Research Associates, LLCHuntsville, AL
Southern California Research Institute Medical Group, Inc.Los Angeles, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Shanghai Pharma Biotherapeutics USA Inc.Lead Sponsor
References
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]The safety and efficacy of mesalamine enemas were determined ina dose-ranging study enrolling 287 patients with ulcerative proctitis and proctosigmoiditis in a double-blind, placebo-controlled, multicenter trial. Patients were randomized to receive placebo, 1, 2, or 4 g in 100 ml mesalamine (PENTASA) enemas h.s. for 8 weeks. Efficacy was assessed by clinical, sigmoidoscopic, and histologic improvement, as well as by induction of remission. Sixty-seven percent, 65%, and 75% of patients receiving 1-, 2-, and 4-g enemas were markedly improved according to the physician's global assessment compared with 27% of patients treated with placebo. The mean improvement in sigmoidoscopic index was 5.8, 5.9, and 6.4 points (on a 15-point scale) for the 1-, 2-, and 4-g enema groups compared with a decrease of 1.8 points for the placebo group. Improvement in biopsy scores was observed in 47, 55, and 59% of 1-, 2-, and 4-g groups contrasted with 27% of the placebo-treated patients. All three doses were significantly more effective than placebo in reducing symptoms and trips to the toilet compared with placebo. No dose-response relation was demonstrated. The safety profile was similar to that of placebo. In conclusion, mesalamine enemas are effective as a single agent in the short-term treatment of distal ulcerative colitis without an apparent dose response between 1 and 4 g nightly.
Oral 5-aminosalicylic acid for inducing remission in ulcerative colitis. [2018]To assess the efficacy, dose-responsiveness and safety of the newer release formulations of 5-aminosalicylic acid (5-ASA) compared to placebo or sulfasalazine (SASP) for the induction of remission in active ulcerative colitis.
Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis. [2023]Quantifying placebo rates and the factors influencing them are essential to inform trial design. We provide a contemporary summary of clinical, endoscopic, histological and safety placebo rates in induction and maintenance clinical trials of ulcerative colitis, and identify factors influencing them.
Oral 5-aminosalicylic acid for maintaining remission in ulcerative colitis. [2020]To assess the efficacy, dose-responsiveness and safety of the newer release formulations of 5-aminosalicylic acid (5-ASA) compared to placebo or sulfasalazine (SASP) in the maintenance of remission in ulcerative colitis.
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]IBD98-M is a delayed-release formulation of mesalamine (mesalazine) and SH with a potential therapeutic role in ulcerative colitis (UC). A total of 51 patients with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of ≥4 and ≤10, and a modified UCDAI endoscopy subscore ≥1 were randomized for 6 weeks of double-blind treatment with IBD98 0.8 g/day or IBD 1.2 g/day or placebo. The efficacy and safety of IBD98-M in mild to moderate active UC were primarily evaluated. At week 6, 1 (5.9%), 2 (12.5%), and 2 (11.1%) patients receiving IBD98-M 0.8 g, IBD98-M 1.2 g, and placebo, respectively, (p > 0.999) achieved clinical remission. Higher clinical response was seen in IBD98-M 1.2 g (31.3%) versus placebo (16.7%) and endoscopic improvement in IBD98-M 0.8 g (29.4%) versus placebo (22.2%) was seen. Fecal calprotectin levels were reduced in IBD98-M groups versus placebo (p > 0.05). IBD98-M patients achieved significant improvement in physical health summary score component of the SF-36 (p = 0.01 and p = 0.03 respectively) compared to placebo. IBD98-M did not meet the primary end point but had higher clinical response (1.2 g/day) and endoscopic improvement (0.8 g/day) compared to placebo. The safety result shown that IBD98-M treatment was safe and well tolerated in this patient population. No new safety signals or unexpected safety findings were observed during the study. Further trials with different stratification and longer follow-up may be needed to evaluate the efficacy.
Sulfasalazine revisited: a meta-analysis of 5-aminosalicylic acid in the treatment of ulcerative colitis. [2019]To assess the effectiveness of the newer 5-aminosalicylic acid (5-ASA) delivery systems compared with placebo or sulfasalazine for the treatment of active ulcerative colitis and for the maintenance of remission.
Predictors of Placebo Induction Response and Remission in Ulcerative Colitis. [2023]High placebo response rates in clinical trials of ulcerative colitis (UC) have been reported previously. However, data from patient-level analyses are lacking. We assessed factors associated with clinical and endoscopic placebo response among placebo-treated patients in clinical trials of UC.
A longitudinal model for the Mayo Clinical Score and its sub-components in patients with ulcerative colitis. [2022]Clinical trials in patients with ulcerative colitis (UC) face the challenge of high and variable placebo response rates. The Mayo Clinical Score (MCS) is used widely as the primary endpoint in clinical trials to describe the clinical status of patients with UC. The MCS is comprised of four subscores, each scored 0, 1, 2 and 3: rectal bleeding (RB), stool frequency (SF), physician's global assessment (PGA), and endoscopy (ENDO) subscore. Excluding the PGA subscore gives the modified MCS. Quantitative insight on the placebo response, and its impact on the components of the MCS over time, can better inform clinical trial design and interpretation. Longitudinal modeling of the MCS, and the modified MCS, can be challenging due to complex clinical trial design, population heterogeneity, and limited assessments for the ENDO subscore. The current study pooled patient-level placebo/standard of care (SoC) arm data from five clinical trials in the TransCelerate database to develop a longitudinal placebo response model that describes the MCS over time in patients with UC. MCS subscores were modeled using proportional odds models, and the removal of patients from the placebo/SoC arm, or "dropout", was modeled using logistic regression models. The subscore and dropout models were linked to allow for the prediction of the MCS and the modified MCS. Stepwise covariate modeling identified prior exposure to TNF-α antagonists as a statistically significant predictor on the RB + SF subscore. Patients with prior exposure to TNF-α antagonists had higher post-baseline RB + SF subscores than naive patients.