Trial Outcomes & Findings for Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis (NCT NCT05019742)
NCT ID: NCT05019742
Last Updated: 2025-06-26
Results Overview
Number of patients with Clinical remission from baseline to Day 56
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Screening (baseline) to Day 56
Results posted on
2025-06-26
Participant Flow
3 patients enrolled (2 placebo, 1 SPH3127 100 mg) in 16 months. Study terminated for lack of enrollment.
Patients must meet I/E criteria to enroll.
Participant milestones
| Measure |
Placebo
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
Placebo: Placebo
|
SPH3127 50 mg
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.
SPH3127: SPH3127 - selective renin inhibitor
|
SPH3127 100 mg
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: SPH3127 - selective renin inhibitor
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
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
Placebo: Placebo
|
SPH3127 50 mg
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.
SPH3127: SPH3127 - selective renin inhibitor
|
SPH3127 100 mg
n=1 Participants
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: SPH3127 - selective renin inhibitor
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Screening (baseline) to Day 56Population: No (0) subjects enrolled in SPH3127 50 mg group
Number of patients with Clinical remission from baseline to Day 56
Outcome measures
| Measure |
Placebo
n=2 Participants
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
Placebo: Placebo
|
SPH3127 50 mg
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.
SPH3127: SPH3127 - selective renin inhibitor
|
SPH3127 100 mg
n=1 Participants
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: SPH3127 - selective renin inhibitor
|
|---|---|---|---|
|
Number of Patients With Clinical Remission
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Screening (baseline) to Day 56Population: No (0) patients enrolled in SPH3127 50 mg group.
Number of patients with Endoscopic remission from baseline to Day 56
Outcome measures
| Measure |
Placebo
n=2 Participants
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
Placebo: Placebo
|
SPH3127 50 mg
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.
SPH3127: SPH3127 - selective renin inhibitor
|
SPH3127 100 mg
n=1 Participants
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: SPH3127 - selective renin inhibitor
|
|---|---|---|---|
|
Number of Patients With Endoscopic Remission
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient)Population: No (0) patients enrolled in the SPH3127 50 mg group
Number of patients reporting an adverse event (regardless of its relationship to study drug) will be tabulated and classified using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) classification system.
Outcome measures
| Measure |
Placebo
n=2 Participants
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
Placebo: Placebo
|
SPH3127 50 mg
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.
SPH3127: SPH3127 - selective renin inhibitor
|
SPH3127 100 mg
n=1 Participants
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: SPH3127 - selective renin inhibitor
|
|---|---|---|---|
|
Number of Patients Reporting Adverse Events
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SPH3127 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SPH3127 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=2 participants at risk
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
Placebo: Placebo
|
SPH3127 50 mg
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.
SPH3127: SPH3127 - selective renin inhibitor
|
SPH3127 100 mg
n=1 participants at risk
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: SPH3127 - selective renin inhibitor
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
cough
|
50.0%
1/2 • Number of events 1 • Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient).
No patients (0) enrolled in the 50 mg QD treatment group.
|
—
0/0 • Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient).
No patients (0) enrolled in the 50 mg QD treatment group.
|
0.00%
0/1 • Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient).
No patients (0) enrolled in the 50 mg QD treatment group.
|
|
Gastrointestinal disorders
ulcerative colitis flare
|
50.0%
1/2 • Number of events 1 • Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient).
No patients (0) enrolled in the 50 mg QD treatment group.
|
—
0/0 • Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient).
No patients (0) enrolled in the 50 mg QD treatment group.
|
0.00%
0/1 • Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient).
No patients (0) enrolled in the 50 mg QD treatment group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place