Trial Outcomes & Findings for A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (NCT NCT05611671)
NCT ID: NCT05611671
Last Updated: 2025-12-15
Results Overview
* The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of \< or =1; and an endoscopy subscore of \< or =1 without friability.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
280 participants
Primary outcome timeframe
Week 12
Results posted on
2025-12-15
Participant Flow
Participant milestones
| Measure |
MORF-057 200 mg BID
Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks.
|
MORF-057 100 mg BID
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg QD-M
Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks.
|
Placebo
Participants received an oral dose of matching placebo for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
71
|
70
|
70
|
|
Overall Study
Safety Analysis Population
|
70
|
71
|
70
|
69
|
|
Overall Study
COMPLETED
|
65
|
68
|
67
|
65
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
5
|
Reasons for withdrawal
| Measure |
MORF-057 200 mg BID
Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks.
|
MORF-057 100 mg BID
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg QD-M
Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks.
|
Placebo
Participants received an oral dose of matching placebo for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
1
|
Baseline Characteristics
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
Baseline characteristics by cohort
| Measure |
MORF-057 200 mg BID
n=69 Participants
Participants received a 200 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg BID
n=71 Participants
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg QD-M
n=70 Participants
Participants received a 100 mg oral dose of MORF-057 once daily in the morning for 12 weeks.
|
Placebo
n=70 Participants
Participants received an oral dose of matching placebo for 12 weeks.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 17.14 • n=6009 Participants
|
41.8 years
STANDARD_DEVIATION 14.35 • n=42 Participants
|
38.9 years
STANDARD_DEVIATION 13.57 • n=77 Participants
|
39.1 years
STANDARD_DEVIATION 13 • n=387 Participants
|
40.2 years
STANDARD_DEVIATION 14.57 • n=160 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=6009 Participants
|
32 Participants
n=42 Participants
|
31 Participants
n=77 Participants
|
34 Participants
n=387 Participants
|
125 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=6009 Participants
|
39 Participants
n=42 Participants
|
39 Participants
n=77 Participants
|
36 Participants
n=387 Participants
|
155 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=6009 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=77 Participants
|
2 Participants
n=387 Participants
|
6 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=6009 Participants
|
70 Participants
n=42 Participants
|
69 Participants
n=77 Participants
|
68 Participants
n=387 Participants
|
273 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
1 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=6009 Participants
|
11 Participants
n=42 Participants
|
13 Participants
n=77 Participants
|
13 Participants
n=387 Participants
|
51 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=6009 Participants
|
60 Participants
n=42 Participants
|
57 Participants
n=77 Participants
|
57 Participants
n=387 Participants
|
227 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
2 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants.
* The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of \< or =1; and an endoscopy subscore of \< or =1 without friability.
Outcome measures
| Measure |
MORF-057 200 mg BID
n=69 Participants
Participants received a 200 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg BID
n=71 Participants
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg QD-M
n=70 Participants
Participants received a 100 mg oral dose of MORF-057 once daily in the morning for 12 weeks.
|
Placebo
n=70 Participants
Participants received an oral dose of matching placebo for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS)
|
31.9 percentage of participants
|
23.9 percentage of participants
|
17.1 percentage of participants
|
24.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants.
* The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical response per mMCS is defined as decrease from baseline in the mMCS score \> or =2 points and \> or =30% from baseline, plus a decrease in rectal bleeding subscore \> or =1 or an absolute rectal bleeding subscore \< or =1.
Outcome measures
| Measure |
MORF-057 200 mg BID
n=69 Participants
Participants received a 200 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg BID
n=71 Participants
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg QD-M
n=70 Participants
Participants received a 100 mg oral dose of MORF-057 once daily in the morning for 12 weeks.
|
Placebo
n=70 Participants
Participants received an oral dose of matching placebo for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS)
|
62.3 percentage of participants
|
53.5 percentage of participants
|
57.1 percentage of participants
|
54.3 percentage of participants
|
Adverse Events
MORF-057 200 mg BID
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
MORF-057 100 mg BID
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
MORF-057 100 mg QD-M
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MORF-057 200 mg BID
n=70 participants at risk
Participants received a 200 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg BID
n=71 participants at risk
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg QD-M
n=70 participants at risk
Participants received a 100 mg oral dose of MORF-057 once daily in the morning for 12 weeks.
|
Placebo
n=69 participants at risk
Participants received an oral dose of matching placebo for 12 weeks.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/71 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
1.4%
1/69 • Baseline to Week 12
All participants from the safety analysis population set.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.4%
1/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
1.4%
1/71 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/69 • Baseline to Week 12
All participants from the safety analysis population set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
1.4%
1/71 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/69 • Baseline to Week 12
All participants from the safety analysis population set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
1.4%
1/71 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/69 • Baseline to Week 12
All participants from the safety analysis population set.
|
Other adverse events
| Measure |
MORF-057 200 mg BID
n=70 participants at risk
Participants received a 200 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg BID
n=71 participants at risk
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
|
MORF-057 100 mg QD-M
n=70 participants at risk
Participants received a 100 mg oral dose of MORF-057 once daily in the morning for 12 weeks.
|
Placebo
n=69 participants at risk
Participants received an oral dose of matching placebo for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.3%
3/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
4.2%
3/71 • Baseline to Week 12
All participants from the safety analysis population set.
|
0.00%
0/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
5.8%
4/69 • Baseline to Week 12
All participants from the safety analysis population set.
|
|
Nervous system disorders
Headache
|
7.1%
5/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
5.6%
4/71 • Baseline to Week 12
All participants from the safety analysis population set.
|
2.9%
2/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
2.9%
2/69 • Baseline to Week 12
All participants from the safety analysis population set.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
2.8%
2/71 • Baseline to Week 12
All participants from the safety analysis population set.
|
4.3%
3/70 • Baseline to Week 12
All participants from the safety analysis population set.
|
5.8%
4/69 • Baseline to Week 12
All participants from the safety analysis population set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60