Trial Outcomes & Findings for A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC (NCT NCT05291689)
NCT ID: NCT05291689
Last Updated: 2026-03-11
Results Overview
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
From baseline to 12 weeks
Results posted on
2026-03-11
Participant Flow
The study plan included two cohorts. Both cohorts receive the same MORF-057 treatment regimen. * Main cohort for formal assessment of study objectives. Participants in this cohort were biologic-naïve or previously exposed to biologic therapies, with no prior vedolizumab exposure. * Exploratory cohort for exploratory purposes only and not used to assess the study objectives. Participants in this cohort had prior vedolizumab exposure with intolerance or secondary non-response.
Participant milestones
| Measure |
MORF-057 (Main Cohort)
Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks.
|
MORF-057 (Exploratory Cohort)
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
4
|
|
Overall Study
Received at Least One Dose of Study Drug
|
35
|
4
|
|
Overall Study
COMPLETED
|
17
|
1
|
|
Overall Study
NOT COMPLETED
|
18
|
3
|
Reasons for withdrawal
| Measure |
MORF-057 (Main Cohort)
Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks.
|
MORF-057 (Exploratory Cohort)
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
8
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
Baseline Characteristics
A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
Baseline characteristics by cohort
| Measure |
MORF-057 (Main Cohort)
n=35 Participants
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
MORF-057 (Exploratory Cohort)
n=4 Participants
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 14.1 • n=9 Participants
|
59.5 years
STANDARD_DEVIATION 14.36 • n=9 Participants
|
41.3 years
STANDARD_DEVIATION 15.27 • n=18 Participants
|
|
Age, Customized
18 to 64 years
|
34 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
36 Participants
n=18 Participants
|
|
Age, Customized
65 to 84 years
|
1 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
17 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
22 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
38 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
39 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
8 Participants
n=18 Participants
|
|
Region of Enrollment
Poland
|
28 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
31 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 weeksPopulation: Main Cohort: All participants who received at least one dose of study drug.
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
Outcome measures
| Measure |
MORF-057 (Main Cohort)
n=35 Participants
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
|---|---|
|
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
|
-6.4 score on a scale
Standard Deviation 11.18
|
SECONDARY outcome
Timeframe: From baseline to 12 weeksPopulation: Main Cohort: All participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
MORF-057 (Main Cohort)
n=35 Participants
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
|---|---|
|
Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score
|
-2.3 score on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Main Cohort: All participants who received at least one dose of study drug and had evaluable data for this outcome.
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.
Outcome measures
| Measure |
MORF-057 (Main Cohort)
n=28 Participants
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
|---|---|
|
Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057
|
766 ng/mL
Geometric Coefficient of Variation 46.4
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Main Cohort: All participants who received at least one dose of study drug and had evaluable data for this outcome.
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.
Outcome measures
| Measure |
MORF-057 (Main Cohort)
n=28 Participants
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
|---|---|
|
Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057
|
2.014 hours
Geometric Coefficient of Variation 58.4534
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Main Cohort: All participants who received at least one dose of study drug and had evaluable data for this outcome.
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.
Outcome measures
| Measure |
MORF-057 (Main Cohort)
n=27 Participants
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
|---|---|
|
Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057
|
3070 hours*ng/mL
Geometric Coefficient of Variation 45.7
|
Adverse Events
MORF-057 (Main Cohort)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
MORF-057 (Exploratory Cohort)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MORF-057 (Main Cohort)
n=35 participants at risk
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
MORF-057 (Exploratory Cohort)
n=4 participants at risk
Participants received MORF-057 100 mg orally twice daily for up to 78 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
3/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
25.0%
1/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Cardiac disorders
Bundle branch block right
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Gastrointestinal disorders
Anal fistula
|
5.7%
2/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
20.0%
7/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
100.0%
4/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Gastrointestinal disorders
Tongue coated
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Gastrointestinal disorders
Tongue discomfort
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Bronchitis
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Covid-19
|
5.7%
2/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Diarrhoea infectious
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
25.0%
1/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Influenza
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
2/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Rhinitis
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
25.0%
1/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Tooth infection
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.7%
2/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Investigations
Glomerular filtration rate decreased
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Renal and urinary disorders
Chromaturia
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Renal and urinary disorders
Proteinuria
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.7%
2/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
25.0%
1/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Vascular disorders
Hot flush
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
0.00%
0/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
25.0%
1/4 • From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Per the study protocol: "The results of this study may be published or presented at scientific meetings. If this is foreseen, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission."
- Publication restrictions are in place
Restriction type: OTHER