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SPH3127 for Ulcerative Colitis
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (baseline) to day 336 (optional additional 10 months active treatment extension)
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective for treating ulcerative colitis.
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.Check my eligibility
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).See study design
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 belowSelect...
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.
Select...
My ulcerative colitis is active and affects areas at least 15 cm from the anal verge.
Select...
My drug test results were negative.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Modified Mayo Clinical Score (MMCS)
Secondary outcome measures
Change from baseline in Robarts Histopathology Index (RHI)
Change from baseline in UC-100 score
Change from baseline in fecal calprotectin
+1 moreOther outcome measures
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
Placebo
1995
Completed Phase 3
~2670
SPH3127
2022
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Shanghai Pharma Biotherapeutics USA Inc.Lead Sponsor
1 Previous Clinical Trials
33 Total Patients Enrolled
Kenneth W. Locke, PhDStudy DirectorShanghai Pharma Biotherapeutics USA Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am a male agreeing to use or already using birth control, or I am surgically sterilized.I have not taken certain medications recently.I have had significant blood loss or a recent transfusion.I do not have serious diseases other than ulcerative colitis.My kidney function is reduced.My ulcerative colitis is active and affects areas at least 15 cm from the anal verge.I am not on medications known to harm organs.I do not have any active infections.I have a known immune system disorder.I have liver problems or a history of liver cirrhosis.I have been diagnosed with severe ulcerative colitis.My drug test results were negative.I have a history of certain medical conditions or procedures.I have had cancer before.I am not pregnant, will use birth control during the study, or cannot become pregnant due to menopause or surgery.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: SPH3127 100 mg
- Group 2: Placebo
- Group 3: SPH3127 50 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants being accepted for this medical experiment at the present time?
"Confirmed, recruitment is still ongoing for this medical trial. It was first advertised on March 21st 2022 and has been kept up-to-date since April 4th of the same year."
Answered by AI
Are there sizable numbers of hospitals conducting this investigation in the city?
"At the moment, this experiment is recruiting individuals from 16 distinct sites spread throughout Wyoming, Mission Hills and Ventura as well as 13 other locations. Consequently, it's wise to pick a nearby centre so that you can reduce unnecessary travel if chosen for participation."
Answered by AI
Is this investigation open to participants who are over two decades of age?
"The rules of acceptance for this medical trial dictate that patients must be between 18 and 70 years old. There are separate trials designed specifically for those below the age of consent (70) as well as a different set for adults over 65 (345)."
Answered by AI
Is it possible for me to enroll in this research?
"Aspiring participants of this medical trial must possess ulcerative colitis and be between the ages of 18 to 70, with a target enrollment total of 30 individuals."
Answered by AI
What is the cap on participant numbers for this experiment?
"30 qualified individuals must join this trial in order to meet its requirements. Participants can take part from Gastroenterology Associates of Western Michigan, PLC located in Wyoming, MI and Facey Medical Group at Facey Medical Foundation based in Mission Hills, CA."
Answered by AI
To what extent can SPH3127 be considered hazardous to patients?
"The safety of SPH3127 was graded a 2 as Phase 2 trials have some evidence demonstrating the drug's security but not its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
New Jersey
New York
Other
How old are they?
18 - 65
What site did they apply to?
Atlanta Center for Gastroenterology, P.C.
Gastro Health & Nutrition - Victoria
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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