Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, UC, Efavaleukin Alfa
Brief summary
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.
Interventions
DRUGEfavaleukin alfa
Efavaleukin alfa will be administered by subcutaneous (SC) injection.
DRUGPlacebo
Placebo will be administered by SC injection.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities or procedures. * Men and women aged ≥ 18 to \< 80 years at screening visit (≥ 19 to \< 80 in South Korea). * Diagnosis of UC established ≥ 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. If a histopathology report is not available at screening, then additional biopsies may be taken during the screening period for local histopathology analysis to corroborate. * Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy subscore ≥ 2. * Has documentation of: * A surveillance colonoscopy (performed according to local standard) within 12 months of day 1 visit for participants with pancolitis of \> 8 years duration, or participants with left-sided colitis of \> 12 years duration, or participants with primary sclerosing cholangitis. * At the discretion of the investigator, a colonoscopy (instead of a rectosigmoidoscopy) may be performed as the screening endoscopy for this study. * For all other participants, up-to-date colorectal cancer surveillance (performed according to local standard). Participants who do not have a colonoscopy report available in source documentation will have a colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study. * Participants must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, Janus kinase \[JAK\]-inhibitor or or S1P modulators), as follows: 1. Conventional therapy failed participants: * Corticosteroids (corticosteroid-refractory colitis, defined as signs and/or symptoms of active UC despite oral prednisone \[or equivalent\] at doses of at least 30 mg/day for a minimum of 2 weeks; or corticosteroid-dependent colitis, defined as: an inability to reduce corticosteroids below the equivalent of prednisone 10 mg/day within 3 months of starting corticosteroids without a return of signs and/or symptoms of active UC; or a relapse within 3 months of completing a course of corticosteroids). * History of intolerance of corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/ osteoporosis, hyperglycemia, or neuropsychiatric side-effects, including insomnia, associated with corticosteroid treatment). * Immunomodulators: signs and/or symptoms of persistently active disease despite at least 3 months treatment with one of the following at locally approved doses: oral azathioprine (eg, ≥ 1.5 mg/kg/day) or 6-mercaptopurine (eg, ≥ 0.75 mg/kg/day), or oral azathioprine or 6-mercatopurine within a therapeutic range as judged by thioguanine metabolite testing, or a combination of a thiopurine and allopurinol within a therapeutic range as judged by thioguanine metabolite testing. * History of intolerance to at least 1 immunomodulator (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia) and have neither failed nor demonstrated an intolerance to a biological medication (anti-tumor necrosis factor \[TNF\] antibody, anti-integrin antibody, or interleukin \[IL\]-12/23 antagonists) that is indicated for the treatment of UC. 2. Biologic or targeted small molecule therapy failed participants: those who demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors or S1P modulators). The therapy used to qualify the participant for entry into this category must be approved for the treatment of UC in the country of use, at the time of use. Participants must fulfil one of the following criteria: * Inadequate response: signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing that was indicated in the product label at the time of use. * Loss of response: recurrence of signs and symptoms of active disease during approved maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not quality as having failed or being intolerant to UC biological therapy, JAK inhibitor, or S1P modulators). * Intolerance: history of intolerance to infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib or other approved biologicals, JAK inhibitors or S1P modulators (including but not limited to infusion-related event, demyelination, congestive heart failure, or any other drug-related adverse event that led to a reduction in dose or discontinuation of the medication). * If receiving any of the following therapies, participants must have stable dosage for the specified duration: * 5-aminosalicylates (ASAs), stable dosage for ≥ 2 weeks prior to screening endoscopy. * Oral corticosteroids: prednisone ≤ 20 mg/day or its equivalent, stable dose for ≥ 2 weeks prior to screening endoscopy. * Budesonide: extended release tablets 9 mg/day \[budensonide MMX\], stable dose for ≥ 2 weeks prior to screening endoscopy. * Beclomethasone dipropionate: gastro-resistant prolonged-release tablet 5 mg/day, stable dose for \>= 2 weeks prior to screening endoscopy. * Conventional immunomodulators: azathioprine, 6-mercaptopurine, methotrexate, stable dosage for ≥ 12 weeks prior to screening endoscopy. Key
Exclusion criteria
* Diagnosis of Crohn's disease, inflammatory bowel disease unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease. * Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon. * Participant has had extensive surgery for UC (for example, subtotal colectomy), or is likely to require surgery for the treatment of UC during the study. * Currently receiving or had treatment within 12 months prior to screening with T cell depleting agents (eg, antithymocyte globulin, Campath). * Participant has received any of the following prescribed medication or therapy within the specified time period: * Anti TNF antibodies (eg, infliximab, adalimumab, golimumab) \< 8 weeks prior to screening rectosigmoidoscopy. * Anti integrin antibodies (eg, vedolizumab) \< 8 weeks prior to screening rectosigmoidoscopy. * IL 12/23 antagonist (eg, ustekinumab) \< 8 weeks prior to screening rectosigmoidoscopy. * JAK inhibitors (eg, tofacitinib) \< 4 weeks prior to screening rectosigmoidoscopy. * Any other commercially approved biologic agent or targeted small molecule \< 8 weeks prior to screening rectosigmoidoscopy or \< 5 half lives prior to screening rectosigmoidoscopy, whichever is longer * Immunomodulatory medications, including oral cyclosporine, intravenous cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, thalidomide \< 4 weeks prior to screening rectosigmoidoscopy. * Any investigational biologic therapy within 8 weeks prior to screening rectosigmoidoscopy or \< 5 half-lives prior to screening rectosigmoidoscopy, whichever is longer. * Has used apheresis (eg, Adacolumnâ apheresis) \< 2 weeks prior to screening rectosigmoidoscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Remission at Week 12 | Week 12 | Clinical remission was defined as a modified Mayo score of 0 to 2, including a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and a centrally read endoscopy subscore of 0 or 1 (modified so that 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Endoscopic Remission at Week 12 | Week 12 | Endoscopic remission was defined as a Mayo centrally read endoscopy subscore of 0 or 1 (modified so that a score of 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease. |
| Percentage of Participants With Symptomatic Remission at Week 12 | Week 12 | Symptomatic remission was defined as Mayo stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0. The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease. |
| Percentage of Participants With Clinical Response at Week 12 | Baseline and Week 12 | Clinical response was defined as a decrease from baseline in the modified Mayo score of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding subscore of 0 or 1. The modified Mayo score was the total Mayo score without the physician's global assessment subscore and ranged from 0 to 9 points, with higher scores indicating more severe disease. Only participants who had the opportunity to complete the visit by the date of the decision for the study termination were included in this outcome measure. Efficacy data collected after this date were censored and excluded from analyses. |
| Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score | Baseline to Week 12 | The Geboes score was an instrument used to standardize histologic assessment in ulcerative colitis (UC). It comprised seven categories (or grades), each describing a histologic feature. These categories were as follows: grade 0, structural (architectural change); grade 1, chronic inflammatory infiltrate; grade 2A, lamina propria eosinophils; grade 2B, lamina propria neutrophils; grade 3, neutrophils in epithelium; grade 4, crypt destruction; and grade 5, erosion or ulceration. Each grade included subscores that indicated the degree of abnormality observed for that histologic feature. Subscores ranged from 0 to 5.4, where a score of 0 indicated no or minimal inflammation, and a maximum score of 5.4 reflected severe histological activity. |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to 12 weeks | TEAEs were events categorized as adverse events (AEs) that started on or after the first dose of investigational product (IP), and up to 12 weeks in induction period. |
| Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12 | Week 12 | Combined endoscopic and histologic remission was defined as combined endoscopic remission (Mayo centrally read endoscopy subscore of 0 or 1) and histologic remission of the colon tissue (Geboes Score \< 2.0; no neutrophils in epithelium crypts or lamina propria and no increase in eosinophils, no crypt destruction and no erosions, ulcerations or granulation tissue). Geobes score was defined as: grade 0, structural (architectural change); grade 1, chronic inflammatory infiltrate; grade 2A, lamina propria eosinophils; grade 2B, lamina propria neutrophils; grade 3, neutrophils in epithelium; grade 4, crypt destruction; and grade 5, erosion or ulceration. Each grade included subscores that indicated degree of abnormality, with subscores of 0 indicating normal appearance and higher subscores indicating increasingly abnormal appearance. The modified Mayo score was total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease. |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Mexico, Netherlands, Poland, Romania, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United States
Participant flow
Recruitment details
The trial was conducted at 200 centers in 26 countries (Argentina, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Mexico, Netherlands, Poland, Romania, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey, and the United States) between January 2022 to October 2024.
Pre-assignment details
Participants were randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period in 1:1:1:1 ratio. Participants who completed the 12-week induction period had the option to enter an exploratory long-term treatment (LTT) period for up to 40 weeks (total of up to 52 weeks of treatment). The study was terminated due to meeting a predefined futility criterion and not related to any safety concerns.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Q2W Participants received placebo matching efavaleukin alfa Q2W through a SC injection for up to 52 weeks. Participants randomized to placebo who achieved clinical response continued in placebo, while those who did not achieve clinical response at week 12 were reassigned in a blinded manner to efavaleukin alfa 1100 mcg Q2W during the LTT period. | 57 |
| Efavaleukin Alfa 400 µg Q2W Participants received efavaleukin alfa 400 mcg Q2W through a SC injection for up to 52 weeks. | 57 |
| Efavaleukin Alfa 1100 µg Q2W Participants received efavaleukin alfa 1100 mcg Q2W through a SC injection for up to 52 weeks. | 54 |
| Efavaleukin Alfa 1800 µg Q2W Participants received efavaleukin alfa 1800 mcg Q2W through a SC injection for up to 52 weeks. | 53 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Decision by sponsor | 10 | 13 | 11 | 9 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Protocol-specified criteria | 2 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 34 | 30 | 29 | 35 |
Baseline characteristics
| Characteristic | Total | Efavaleukin Alfa 1800 µg Q2W | Efavaleukin Alfa 1100 µg Q2W | Efavaleukin Alfa 400 µg Q2W | Placebo Q2W |
|---|---|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 15.2 | 44.6 years STANDARD_DEVIATION 15.2 | 44.7 years STANDARD_DEVIATION 16.8 | 43.8 years STANDARD_DEVIATION 14.4 | 44.3 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 5 Participants | 8 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 176 Participants | 42 Participants | 45 Participants | 47 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 6 Participants | 1 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 29 Participants | 5 Participants | 7 Participants | 9 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Missing | 13 Participants | 5 Participants | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 2 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 169 Participants | 39 Participants | 45 Participants | 40 Participants | 45 Participants |
| Sex: Female, Male Female | 86 Participants | 23 Participants | 17 Participants | 17 Participants | 29 Participants |
| Sex: Female, Male Male | 135 Participants | 30 Participants | 37 Participants | 40 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 14 | 0 / 42 | 0 / 57 | 0 / 53 | 0 / 53 |
| other Total, other adverse events | 39 / 57 | 9 / 14 | 29 / 42 | 47 / 57 | 44 / 53 | 46 / 53 |
| serious Total, serious adverse events | 5 / 57 | 0 / 14 | 5 / 42 | 3 / 57 | 7 / 53 | 9 / 53 |
Outcome results
Primary
Percentage of Participants With Clinical Remission at Week 12
Clinical remission was defined as a modified Mayo score of 0 to 2, including a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and a centrally read endoscopy subscore of 0 or 1 (modified so that 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.
Time frame: Week 12
Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Clinical Remission at Week 12 | 7.5 percentage of participants |
| Efavaleukin Alfa 400 µg Q2W | Percentage of Participants With Clinical Remission at Week 12 | 9.8 percentage of participants |
| Efavaleukin Alfa 1100 µg Q2W | Percentage of Participants With Clinical Remission at Week 12 | 9.6 percentage of participants |
| Efavaleukin Alfa 1800 µg Q2W | Percentage of Participants With Clinical Remission at Week 12 | 10.4 percentage of participants |
p-value: 0.795% CI: [-8.6, 12.8]Logistic regression model
p-value: 0.7295% CI: [-8.6, 12.6]Logistic regression model
p-value: 0.5895% CI: [-8, 14.2]Logistic regression model
Secondary
Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score
The Geboes score was an instrument used to standardize histologic assessment in ulcerative colitis (UC). It comprised seven categories (or grades), each describing a histologic feature. These categories were as follows: grade 0, structural (architectural change); grade 1, chronic inflammatory infiltrate; grade 2A, lamina propria eosinophils; grade 2B, lamina propria neutrophils; grade 3, neutrophils in epithelium; grade 4, crypt destruction; and grade 5, erosion or ulceration. Each grade included subscores that indicated the degree of abnormality observed for that histologic feature. Subscores ranged from 0 to 5.4, where a score of 0 indicated no or minimal inflammation, and a maximum score of 5.4 reflected severe histological activity.
Time frame: Baseline to Week 12
Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score | -0.53 score on scale | Standard Deviation 1.31 |
| Efavaleukin Alfa 400 µg Q2W | Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score | -0.30 score on scale | Standard Deviation 1.39 |
| Efavaleukin Alfa 1100 µg Q2W | Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score | -0.34 score on scale | Standard Deviation 1.49 |
| Efavaleukin Alfa 1800 µg Q2W | Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score | -0.45 score on scale | Standard Deviation 1.04 |
p-value: 0.3995% CI: [-0.3, 0.7]ANCOVA
p-value: 0.4995% CI: [-0.3, 0.7]ANCOVA
p-value: 0.7695% CI: [-0.5, 0.6]ANCOVA
Secondary
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
TEAEs were events categorized as adverse events (AEs) that started on or after the first dose of investigational product (IP), and up to 12 weeks in induction period.
Time frame: Up to 12 weeks
Population: Safety analysis set included all participants randomized and received at least 1 dose of IP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Q2W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 33 Participants |
| Efavaleukin Alfa 400 µg Q2W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 42 Participants |
| Efavaleukin Alfa 1100 µg Q2W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 42 Participants |
| Efavaleukin Alfa 1800 µg Q2W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 46 Participants |
Secondary
Percentage of Participants With Clinical Response at Week 12
Clinical response was defined as a decrease from baseline in the modified Mayo score of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding subscore of 0 or 1. The modified Mayo score was the total Mayo score without the physician's global assessment subscore and ranged from 0 to 9 points, with higher scores indicating more severe disease. Only participants who had the opportunity to complete the visit by the date of the decision for the study termination were included in this outcome measure. Efficacy data collected after this date were censored and excluded from analyses.
Time frame: Baseline and Week 12
Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Clinical Response at Week 12 | 20.8 percentage of participants |
| Efavaleukin Alfa 400 µg Q2W | Percentage of Participants With Clinical Response at Week 12 | 19.6 percentage of participants |
| Efavaleukin Alfa 1100 µg Q2W | Percentage of Participants With Clinical Response at Week 12 | 25.0 percentage of participants |
| Efavaleukin Alfa 1800 µg Q2W | Percentage of Participants With Clinical Response at Week 12 | 25.0 percentage of participants |
p-value: 0.8995% CI: [-16.3, 14.2]Logistic regression model
p-value: 0.5695% CI: [-11.1, 20.6]Logistic regression model
p-value: 0.5995% CI: [-11.7, 20.7]Logistic regression model
Secondary
Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12
Combined endoscopic and histologic remission was defined as combined endoscopic remission (Mayo centrally read endoscopy subscore of 0 or 1) and histologic remission of the colon tissue (Geboes Score \< 2.0; no neutrophils in epithelium crypts or lamina propria and no increase in eosinophils, no crypt destruction and no erosions, ulcerations or granulation tissue). Geobes score was defined as: grade 0, structural (architectural change); grade 1, chronic inflammatory infiltrate; grade 2A, lamina propria eosinophils; grade 2B, lamina propria neutrophils; grade 3, neutrophils in epithelium; grade 4, crypt destruction; and grade 5, erosion or ulceration. Each grade included subscores that indicated degree of abnormality, with subscores of 0 indicating normal appearance and higher subscores indicating increasingly abnormal appearance. The modified Mayo score was total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.
Time frame: Week 12
Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12 | 0.0 percentage of participants |
| Efavaleukin Alfa 400 µg Q2W | Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12 | 7.8 percentage of participants |
| Efavaleukin Alfa 1100 µg Q2W | Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12 | 1.9 percentage of participants |
| Efavaleukin Alfa 1800 µg Q2W | Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12 | 0.0 percentage of participants |
p-value: 0.1195% CI: [0, 16.9]Logistic regression model
p-value: 0.4695% CI: [-3.4, 7.7]Logistic regression model
p-value: 0.9495% CI: [-4, 4.3]Logistic regression model
Secondary
Percentage of Participants With Endoscopic Remission at Week 12
Endoscopic remission was defined as a Mayo centrally read endoscopy subscore of 0 or 1 (modified so that a score of 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.
Time frame: Week 12
Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Endoscopic Remission at Week 12 | 11.3 percentage of participants |
| Efavaleukin Alfa 400 µg Q2W | Percentage of Participants With Endoscopic Remission at Week 12 | 15.7 percentage of participants |
| Efavaleukin Alfa 1100 µg Q2W | Percentage of Participants With Endoscopic Remission at Week 12 | 11.5 percentage of participants |
| Efavaleukin Alfa 1800 µg Q2W | Percentage of Participants With Endoscopic Remission at Week 12 | 12.5 percentage of participants |
p-value: 0.5295% CI: [-8.7, 17.2]Logistic regression model
p-value: 0.9795% CI: [-11.8, 12.2]Logistic regression model
p-value: 0.8295% CI: [-11.1, 14]Logistic regression mode
Secondary
Percentage of Participants With Symptomatic Remission at Week 12
Symptomatic remission was defined as Mayo stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0. The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.
Time frame: Week 12
Population: FAS included all participants randomized. Only participants with available data were included in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Symptomatic Remission at Week 12 | 15.1 percentage of participants |
| Efavaleukin Alfa 400 µg Q2W | Percentage of Participants With Symptomatic Remission at Week 12 | 17.6 percentage of participants |
| Efavaleukin Alfa 1100 µg Q2W | Percentage of Participants With Symptomatic Remission at Week 12 | 23.1 percentage of participants |
| Efavaleukin Alfa 1800 µg Q2W | Percentage of Participants With Symptomatic Remission at Week 12 | 22.9 percentage of participants |
p-value: 0.395% CI: [-7.1, 23.3]Logistic regression model
p-value: 0.7295% CI: [-11.6, 16.7]Logistic regression model
p-value: 0.2895% CI: [-6.6, 23.1]Logistic regression model