This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)
The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Clinical Study Site
Tampa, Florida, United States
Clinical Study Site
Lafayette, Louisiana, United States
Clinical Study Site
Freehold, New Jersey, United States
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
Time frame: From baseline to 12 weeks
Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score
The Modified Mayo Clinic Score (mMCS) is a composite of the following Mayo Clinic Score subscores: Endoscopy subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration), Stool Frequency subscore (range: 0=Normal number of stools for this participant to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The total mMCS ranges from 0 to 9, with higher scores indicating more severe disease.
Time frame: From baseline to 12 weeks
Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057
To determine the Maximum Plasma Concentration of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
Time frame: 12 weeks
Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057
To determine the Tmax of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
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Clinical Study Site
Brooklyn, New York, United States
Clinical Study Site
New York, New York, United States
Clinical Study Site
Bydgoszcz, Poland
Clinical Study Site
Elblag, Poland
Clinical Study Site
Katowice, Poland
Clinical Study Site
Lodz, Poland
Clinical Study Site
Lodz, Poland
...and 7 more locations
Time frame: 12 weeks
Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057
To determine the area under the concentration-time curve of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
Time frame: 12 weeks