Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score |
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score =2 points with no individual subscore >1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity. |
At Week 8 |
|
Secondary |
Percentage of Participants Achieving Clinical Remission at Week 52 Based on Complete Mayo Score |
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score =2 points with no individual subscore >1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity |
At Week 52 |
|
Secondary |
Percentage of Participants Achieving Clinical Remission at Weeks 8, 14, and 26 Based on Partial Mayo Score |
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score =2 points with no individual subscore >1. Partial Mayo Score consists of 3 variables of the Mayo Clinic Score: stool frequency, rectal bleeding and PGA. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease. These scores are summed to give a total score range of 0 to 9 where higher scores indicate maximum disease activity.. |
At Weeks 8, 14 and 26 |
|
Secondary |
Percentage of Participants Achieving Clinical Response at Weeks 2, 6, 8, 14, 26 and 52 Based on Complete or Partial Mayo Score |
Clinical response based on complete Mayo Score is where a participant achieves a reduction in complete Mayo score of =3 points and =30% from Baseline or a partial Mayo score of =2 points and =25% from baseline, if the complete Mayo score was not performed at the visit with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity. |
At Weeks 2, 6, 8, 14, 26, and 52 |
|
Secondary |
Percentage of Participants Achieving Clinical Remission at Week 8 and Week 52 Based on Modified Mayo Score |
Clinical remission based on modified Mayo Score is where a participant achieves component modified Mayo score of =2 with modified MES =1, rectal bleeding = 0, and stool frequency =1. Modified Mayo Score consists of 3 variables: stool frequency, rectal bleeding and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease. These scores are summed to give a total score range of 0 to 9 where higher scores indicate maximum disease activity. |
At Weeks 8 and 52 |
|
Secondary |
Percentage of Participants With Durable Clinical Remission at Week 8 and Week 52 |
Durable clinical remission is defined as the clinical remission at Week 8 and Week 52. Clinical remission is defined as complete Mayo Score of =2 points and no individual subscore >1 point at Weeks 8 and 52. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity. |
At Week 8 and Week 52 |
|
Secondary |
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 8 |
Clinical remission is defined as complete Mayo Score of =2 points and no individual subscore >1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity. |
At Week 8 |
|
Secondary |
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 8 |
Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 8. Clinical remission is defined as complete Mayo Score of =2 points and no individual subscore >1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity. |
At Week 8 |
|
Secondary |
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 52 |
Clinical remission is defined as complete Mayo Score of =2 points and no individual subscore >1 point at Week 52. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity. |
At Week 52 |
|
Secondary |
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 52 |
Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 52, and was off corticosteroids at least 3 months prior to Week 52. Clinical remission is defined as complete Mayo Score of =2 points and no individual subscore >1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity. |
At Week 52 |
|
Secondary |
Percentage of Participants Achieving Clinical Response at Week 8 |
Clinical response based on complete Mayo Score is where a participant achieves a reduction in complete Mayo score of =3 points and =30% from Baseline with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity. |
At Week 8 |
|
Secondary |
Percentage of Participants With Mucosal Healing Based on MES at Week 52 |
Mucosal healing is defined as MES =1 point at Week 52. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy were 0= Normal appearance of mucosa, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease. |
At Week 52 |
|
Secondary |
Percentage of Participants With Histological Remission Based on Geboes Score at Week 52 |
Histological remission is defined as Geboes score <2 at Week 52. The Geboes score is a histological grading system for assessing histological disease activity in UC. The Geboes score evaluates 7 histological features. It consists of 6 grades (0-6). Each of the grades is divided into subgrades, based on the severity of tissue abnormalities or the extent of inflammatory cell infiltration. The Geboes score ranges from 0.0 to 5.4, and higher grades are indicative of more severe disease activity. |
At Week 52 |
|
Secondary |
Change in C-Reactive Protein Levels (CRP) From Baseline |
CRP is a useful marker of inflammation in participants with inflammatory bowel disease (IBD). In participants with UC, elevated CRP has been associated with severe clinical activity |
Baseline to Weeks 2, 6, 8, 14, 26, 42 and 52 |
|
Secondary |
Change in Fecal Calprotectin Concentrations From Baseline |
Fecal calprotectin is a biomarker for intestinal inflammatory activity. |
Baseline to Weeks 2, 6, 8, 14, 26, 42 and 52 |
|
Secondary |
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline |
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
At Weeks 8, 26 and 52 |
|
Secondary |
Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline |
The FACIT-F is a validated, 13-item questionnaire to assess fatigue in participants with a variety of chronic illnesses, including participants with IBD. Items are rated on a 5-point Likert scale and the total score ranges from 0 to 52 with lower scores representing greater fatigue. |
At Weeks 8, 26 and 52 |
|
Secondary |
Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention. |
Up to 76 Weeks |
|
Secondary |
Number of Participants With Clinically Significant Change in Vital Signs From Baseline |
Vital signs will include body temperature, respiratory rate, blood pressure (resting more than 5 minutes), and pulse (resting more than 5 minutes). |
Up to 76 Weeks |
|
Secondary |
Number of Participants With Clinically Significant Physical Examination Findings |
A baseline physical examination (defined as the assessment before first dose of study medication) will consist of the following body systems: general appearance; HEENT (head, eyes, ears, nose, and throat); cardiovascular system; respiratory system; gastrointestinal system; dermatologic system; extremities; musculoskeletal system; nervous system; lymph nodes; and other. All subsequent physical examinations will assess clinically significant changes from the assessment prior to first dose examination. |
At Baseline and From Week 14 to Week 72 |
|
Secondary |
Number of Participants With Markedly Abnormal Laboratory Values |
Standard laboratory tests will include clinical chemistry, hematology, coagulation and urinalysis. |
Up to Week 76 |
|