Ulcerative Colitis
Conditions
Brief summary
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis
Interventions
BIOLOGICALCT-P13 SC (Infliximab)
Subcutaneous injection of CT-P13 SC
OTHERPlacebo SC
Subcutaneous injection of Placebo SC
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient is male or female aged 18 to 75 years, inclusive. * Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points
Exclusion criteria
* Patient who has previously received 2 or more biologic agents and/or JAK inhibitors * Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving Clinical Remission at Week 54 | Week 54 | Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Patients Achieving Clinical Response at Week 54 | Week 54 | Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. |
| Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54 | Week 54 | Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved. |
| Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54 | Week 54 | Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT-P13 SC 120 mg CT-P13 SC 120 mg | 294 |
| Placebo Placebo | 144 |
| Total | 438 |
Baseline characteristics
| Characteristic | Placebo | Total | CT-P13 SC 120 mg |
|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 13.49 | 38.9 years STANDARD_DEVIATION 13.04 | 38.2 years STANDARD_DEVIATION 12.78 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 140 Participants | 428 Participants | 288 Participants |
| Region of Enrollment Belarus | 0 participants | 3 participants | 3 participants |
| Region of Enrollment Bulgaria | 2 participants | 6 participants | 4 participants |
| Region of Enrollment Croatia | 2 participants | 11 participants | 9 participants |
| Region of Enrollment Czechia | 6 participants | 11 participants | 5 participants |
| Region of Enrollment Israel | 1 participants | 3 participants | 2 participants |
| Region of Enrollment Italy | 5 participants | 15 participants | 10 participants |
| Region of Enrollment Latvia | 1 participants | 4 participants | 3 participants |
| Region of Enrollment Mexico | 4 participants | 10 participants | 6 participants |
| Region of Enrollment Poland | 65 participants | 200 participants | 135 participants |
| Region of Enrollment Russia | 21 participants | 77 participants | 56 participants |
| Region of Enrollment Serbia | 8 participants | 20 participants | 12 participants |
| Region of Enrollment South Africa | 1 participants | 3 participants | 2 participants |
| Region of Enrollment Turkey | 2 participants | 9 participants | 7 participants |
| Region of Enrollment Ukraine | 26 participants | 66 participants | 40 participants |
| Sex: Female, Male Female | 61 Participants | 192 Participants | 131 Participants |
| Sex: Female, Male Male | 83 Participants | 246 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 548 | 0 / 296 | 0 / 140 |
| other Total, other adverse events | 89 / 548 | 60 / 296 | 37 / 140 |
| serious Total, serious adverse events | 23 / 548 | 15 / 296 | 4 / 140 |
Outcome results
Primary
Percentage of Patients Achieving Clinical Remission at Week 54
Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Time frame: Week 54
Population: All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage of Patients Achieving Clinical Remission at Week 54 | 127 Participants |
| Placebo | Percentage of Patients Achieving Clinical Remission at Week 54 | 30 Participants |
p-value: <0.000195% CI: [11.8, 29.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54
Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Time frame: Week 54
Population: Patients who used oral corticosteroids at baseline among the All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54 | 44 Participants |
| Placebo | Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54 | 11 Participants |
Secondary
Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54
Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved.
Time frame: Week 54
Population: All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54 | 105 Participants |
| Placebo | Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54 | 24 Participants |
Secondary
Percentage Patients Achieving Clinical Response at Week 54
Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
Time frame: Week 54
Population: All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage Patients Achieving Clinical Response at Week 54 | 158 Participants |
| Placebo | Percentage Patients Achieving Clinical Response at Week 54 | 45 Participants |