SPH3127 for Colitis, Ulcerative

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Clinical Research Associates, LLC, Huntsville, AL
Colitis, Ulcerative+3 More
SPH3127 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug called SPH3127 is safe and effective for treating ulcerative colitis.

See full description

Eligible Conditions

  • Colitis, Ulcerative
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Colitis, Ulcerative

Study Objectives

This trial is evaluating whether SPH3127 will improve 1 primary outcome, 4 secondary outcomes, and 2 other outcomes in patients with Colitis, Ulcerative. Measurement will happen over the course of Screening (baseline) to Day 56 (main study).

Day 1
Mean plasma AUC0-8h of SPH4336
Mean plasma Cmax of SPH4336
Month 10
Change from baseline in Modified Mayo Clinical Score (MMCS)
Change from baseline in Robarts Histopathology Index (RHI)
Change from baseline in UC-100 score
Day 56
Change from baseline in fecal calprotectin
Month 10
Incidence and severity of adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Colitis, Ulcerative

Trial Design

3 Treatment Groups

Placebo
1 of 3
SPH3127 100 mg
1 of 3
SPH3127 50 mg
1 of 3
Experimental Treatment

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. SPH3127 is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Placebo
Drug
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
SPH3127 100 mg
Drug
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.
SPH3127 50 mg
Drug
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2810
SPH3127
2016
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening (baseline) to day 336 (optional additional 10 months active treatment extension)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly screening (baseline) to day 336 (optional additional 10 months active treatment extension) for reporting.

Closest Location

Clinical Research Associates, LLC - Huntsville, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male patients with partners of child-bearing potential who agree to use adequate birth control methods throughout the entire study (and extension, if applicable) or who have been surgically sterilized.
Signed Informed Consent Form (ICF);
Adult males and females ≥ 18 to < 70 years of age on the day of signing the ICF.
A diagnosis of UC (documented or confirmed at screening) will be eligible provided they have mild-to-moderate active UC extending ≥ 15 cm from the anal verge.
At screening/baseline, a Modified Mayo Clinic Score (MMCS) from 4-9, a rectal bleeding subscore ≥ 1, and a Mayo Clinic Endoscopic Subscale (MCES) score ≥ 2 determined by central reading.
Patient has a negative urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone) at Screening.
Patient has a negative alcohol breath test at Screening.
Female patients who have a negative pregnancy test at Screening and who agree to use adequate birth control methods throughout the entire study (and extension, if applicable) or who is post-menopausal (i.e., amenorrhea ≥ 1 year) or who have been surgically sterilized.

Patient Q&A Section

What causes colitis?

"The predominant risk factors for development of UC and CD are age, gender, ethnicity and HLA class II alleles. A model based on a combination of specific HLA-DR/DQ alleles and environmental exposures has proven useful to predict the development of UC and CD. Identification of those patients requiring early diagnosis is of great importance in the course of both diseases. Findings from a recent study also indicate a role for certain foods, lifestyle factors and genetic factors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for colitis?

"Colitis shares many general treatment options that are common to the treatment of inflammatory bowel disease overall. Therapies that focus on controlling inflammation or inducing healing may be effective in certain type of colitis. The treatment choices may be more complicated in individual patients because of the severity and progress of the disease. The therapeutic goals are more similar to colitis compared with Crohn's disease because of the tendency to mucosal ulceration, the rarity of fistulas, and the lack of stricturing disease. The treatment in colitis may be more complicated because of the presence of an immune defect." - Anonymous Online Contributor

Unverified Answer

Can colitis be cured?

"About 60% of cases of colitis can be cured, although the average remission length is short. If there is a medical cure, colitis can be suppressed in almost all patients." - Anonymous Online Contributor

Unverified Answer

What are the signs of colitis?

"These can be divided into the following four categories:\n1. Signs that may indicate a condition other than colitis\n2. Indications of an underlying colitis\n3. Symptoms that are a sign of an underlying condition\n4. Symptoms that are the sign of an underlying condition\n\nThe pathogenesis of inflammatory bowel disease is not known, but this is believed to be a complication resulting from chronic, uncontrolled inflammation mediated by tissue damage (inflammation). It arises from a complex interaction of genetic, environmental, and nutritional factors. Inflammation is stimulated by a variety of factors, such as infections, food allergies, and toxins." - Anonymous Online Contributor

Unverified Answer

What is colitis?

"Colitis describes inflammation of the colon. About 3 million Americans have colitis diagnosed and the disease is more frequent in females. The disease can begin with a set of warning symptoms and often requires surgical intervention to alleviate the severity of symptoms. If individuals are not taken and treated early, complications can occur and potentially cause a life-threatening condition called hemorrhagic colitis. Diagnosing colitis can be difficult especially where there are other more obvious signs that seem to be triggering the disorder." - Anonymous Online Contributor

Unverified Answer

How many people get colitis a year in the United States?

"In 1990, 13 million adults and children had at least one episode of chronic abdominal disease. Approximately 11 million of these cases were colitis, but a significant proportion of these cases (30,000) were misdiagnosed as chronic diarrhea. Approximately 90% of colitis patients had the inflammatory form of the disorder. Most of these patients needed only supportive care (76.5% of colitis patients, vs. 18.7% for diarrhea only). An additional 12 million adults had at least one episode of nonspecific gastrointestinal disease. Most of these cases (71%, 63,000) were in a noninflammatory state, and thus were likely to have been misdiagnosed as GI infection, or even misdiagnosed gastroenteritis." - Anonymous Online Contributor

Unverified Answer

How does sph3127 work?

"Sph3127 can exert significant antiinflammatory effects, without affecting viability or function of intestinal epithelial cells in a mouse model of colitis. It is tempting to speculate that sph3127 may be of therapeutic value to treat inflammatory bowel disease." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving sph3127?

"The present study was a preliminary study designed to evaluate the short term effectiveness of SPH3127 for the treatment of UC. Recent findings suggest that the combination of oral steroid and oral SPH3127 have a positive therapeutic effect in the treating UC as compared to the other treatments, but there are limitations in current data." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets colitis?

"About 2% of the study group complained of colitis symptoms when they were 10 years old, whereas 8.1% had UC symptoms when they were 45 years old, suggesting that colitis symptoms typically don't begin until someone is in their 30s--in other words, the typical age of onset of colitis is considerably later than the age of onset of UC, and the former may be more common--but the rate of onset of the two diseases is similar for all ages." - Anonymous Online Contributor

Unverified Answer

What does sph3127 usually treat?

"Sph3127 appears to ameliorate colitis symptoms in most patients in clinical trials, with no apparent exacerbation of symptoms or side effects during the course of the trial." - Anonymous Online Contributor

Unverified Answer

What is sph3127?

"These data support the proposed role of Sph3127 as an antiinflammatory, and suggest that Sph3127 may be used in the management of inflammatory bowel disease." - Anonymous Online Contributor

Unverified Answer

How serious can colitis be?

"Colitis can be very intense disease, it can lead to serious conditions in an untreated patient. It is very important to tell the doctor or gastroenterologist every detail concerning the severity and severity as well as the course because they will provide the best care. In an untreated patient Colitis can be debilitating, with pain and diarrhea, which may result in vomiting, nausea, dehydration and electrolyte imbalance. This situation can lead to dehydration, electrolyte imbalance, anaemia of the bloodstream, which can lead to heart complications. In a few cases, the disease can lead to other serious conditions for example: liver damage and the development of colon cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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