Trial Outcomes & Findings for Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis (NCT NCT05061446)

Last Updated: 2024-10-29

Results Overview

Clinical remission:Participants with stool frequency (SF)subscore=0(or of 1 with greater than or equal to(\>=)1 point decrease from baseline,rectal bleeding(RB)subscore=0 and endoscopic score(ES)less than or equal to(\<)=1(excluding friability).SF subscore:number of stools in 24-hours relative to normal number of stools for that participant in same period,score ranged from 0(normal number of stools) to 3(5 or more stools than normal),higher scores=more severity.RB subscore:most severe amount of blood passed per rectum in 24-hours,score ranged from 0(no blood seen)to 3(blood alone passes),higher scores=more severity.ES:reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,score ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding,ulceration\]),higher scores=more severity.Modified Mayo score:measure disease activity for UC,score:0(normal) to 9(maximum severity),comprised subscores for SF,RB,ES.higher score=more severe disease activity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Week 12

Results posted on

2024-10-29

Participant Flow

A total of 54 Japanese participants with moderate to severely active ulcerative colitis (UC) were enrolled in the study.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Overall Study STARTED	18	17	19
Overall Study COMPLETED	16	16	19
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Overall Study Adverse Event	2	0	0
Overall Study Participant no longer available due to personal reason	0	1	0

Baseline Characteristics

Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=18 Participants Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg n=17 Participants Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg n=19 Participants Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.	Total n=54 Participants Total of all reporting groups
Age, Continuous	38.5 Years STANDARD_DEVIATION 9.28 • n=5 Participants	41.6 Years STANDARD_DEVIATION 14.04 • n=7 Participants	49.5 Years STANDARD_DEVIATION 11.55 • n=5 Participants	43.3 Years STANDARD_DEVIATION 12.45 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	54 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	54 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12

Population: FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies only those participants who had a baseline MMS score between 5 and 9.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg n=15 Participants Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg n=19 Participants Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Percentage of Participants Who Achieved Clinical Remission at Week 12	0 Percentage of participants	6.7 Percentage of participants	26.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Endoscopic improvement was defined as ES \<= 1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity),and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg n=15 Participants Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg n=19 Participants Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12	0 Percentage of participants	6.7 Percentage of participants	26.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Symptomatic remission was defined as SF sub score = 0 (or = 1 with a \>= 1 point decrease from baseline) and RB sub score = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg n=15 Participants Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg n=19 Participants Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Percentage of Participants Who Achieved Symptomatic Remission at Week 12	0 Percentage of participants	20.0 Percentage of participants	31.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Mucosal healing was defined as ES \<= 1 (excluding friability) with histologic remission defined as a Geboes index score \< 2.0). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), comprised subscores for SF, RB, ES. Higher score = more severe disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg n=15 Participants Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg n=19 Participants Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Percentage of Participants Who Achieved Mucosal Healing at Week 12	0 Percentage of participants	6.7 Percentage of participants	5.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Clinical response was defined as a \>= 2-point and \>= 30 percentage (%) decrease from baseline in MMS, and a \>= 1-point decrease from baseline in RB subscore or an absolute RB subscore \<= 1. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg n=15 Participants Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg n=19 Participants Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Percentage of Participants Who Achieved Clinical Response at Week 12	7.1 Percentage of participants	33.3 Percentage of participants	52.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Endoscopic normalization was defined as ES= 0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg n=15 Participants Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg n=19 Participants Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Percentage of Participants Who Achieved Endoscopic Normalization at Week 12	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 of first dose of study treatment up to 4 weeks after administration of the final dose of study treatment (maximum up to 16 weeks)

Population: The safety set included all randomized participants who received at least 1 dose of study treatment.

An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity was classified using common terminology criteria for adverse events (CTCAE), version 5.0, such as Grade 1 for mild, Grade 2 for moderate, Grade 3 for severe, Grade 4 for life-threatening, Grade 5 for death related to adverse event.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Participants received placebo matched to etrasimod once daily, orally for 12 weeks.	Etrasimod 1 mg n=17 Participants Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks.	Etrasimod 2 mg n=19 Participants Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks.
Number of Participants With Adverse Events According to Severity Grade1	5 Participants	6 Participants	11 Participants
Number of Participants With Adverse Events According to Severity Grade 2	5 Participants	3 Participants	2 Participants
Number of Participants With Adverse Events According to Severity Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events According to Severity Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events According to Severity Grade 5	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Etrasimod 1 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Etrasimod 2 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER