Trial Outcomes & Findings for Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (NCT NCT03259334)

Results Overview

Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure consisted of the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

380 participants

Primary outcome timeframe

At Week 12

Results posted on

2021-06-14

Participant Flow

The study was conducted at 192 sites between 9 February 2018 (first participant first visit) and 23 October 2020 (last participant last visit).

A total of 380 subjects were enrolled and randomized, of which 378 subjects received the study treatment in this study.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Study STARTED	76	153	151
Overall Study Treated	76	151	151
Overall Study COMPLETED	66	136	138
Overall Study NOT COMPLETED	10	17	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Study Adverse Event	3	8	5
Overall Study Withdrawal by Subject	4	2	4
Overall Study Physician Decision	1	0	0
Overall Study Lost to Follow-up	0	2	1
Overall Study Protocol Deviation	0	3	2
Overall Study Lack of Efficacy	2	0	1
Overall Study Randomized but never treated	0	2	0

Baseline Characteristics

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Total n=378 Participants Total of all reporting groups
Age, Continuous	38.3 Years STANDARD_DEVIATION 13.33 • n=5 Participants	39.4 Years STANDARD_DEVIATION 13.90 • n=7 Participants	41.2 Years STANDARD_DEVIATION 14.75 • n=5 Participants	39.9 Years STANDARD_DEVIATION 14.14 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	56 Participants n=7 Participants	62 Participants n=5 Participants	151 Participants n=4 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	95 Participants n=7 Participants	89 Participants n=5 Participants	227 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	149 Participants n=7 Participants	146 Participants n=5 Participants	369 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race · 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/Ethnicity, Customized Race · Asian: Japanese	1 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian: Korean	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian: Other	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	72 Participants n=5 Participants	134 Participants n=7 Participants	136 Participants n=5 Participants	342 Participants n=4 Participants
Race/Ethnicity, Customized Race · 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/Ethnicity, Customized Race · Multiple	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Week 12

Population: Full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure consisted of the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Remission at Week 12	12 Participants	28 Participants	45 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Endoscopic Remission at Week 12	16 Participants	42 Participants	62 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Clinical remission was defined by stool frequency (SF) sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding is assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency is assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Clinical Remission at Week 12	29 Participants	61 Participants	76 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (\>=) 1 point or a sub-score for rectal bleeding less than or equal to (\<=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Clinical Response Based on Composite Score at Week 12	34 Participants	76 Participants	99 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of \<=2. The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: Grade 0 equal to (=) 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 indicating more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12	13 Participants	35 Participants	51 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Remission was defined as a total Mayo score of \<=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy \[modified, excluded friability\], and PGA) exceeding 1. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Remission Based on Total Mayo Score at Week 12	11 Participants	25 Participants	40 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Clinical response (Mayo) was defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding \>=1 point or an absolute sub-score for rectal bleeding \<=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Clinical Response Based on Total Mayo Score at Week 12	32 Participants	78 Participants	97 Participants

SECONDARY outcome

Timeframe: At Weeks 4, 8, and 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12 At Week 12	22 Participants	60 Participants	78 Participants
Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12 At Week 4	13 Participants	38 Participants	47 Participants
Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12 At Week 8	23 Participants	57 Participants	62 Participants

SECONDARY outcome

Timeframe: At Weeks 4 and 8

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8 At Week 4	15 Participants	34 Participants	38 Participants
Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8 At Week 8	23 Participants	57 Participants	60 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12	9 Participants	10 Participants	22 Participants

SECONDARY outcome

Timeframe: At Weeks 4, 8, and 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12 At Week 4	7 Participants	20 Participants	15 Participants
Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12 At Week 8	12 Participants	24 Participants	29 Participants
Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12 At Week 12	11 Participants	37 Participants	39 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score \<=1 and a centrally read Geboes score of \<=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. 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 indicating more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants With Deep Remission at Week 12	7 Participants	6 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data of abdominal pain worst severity, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or non-consecutive) of the last 10 days prior to scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Abdominal pain's worst severity assessment was based on an 11-point numerical rating scale with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in e-diary. Higher scores indicating more severe pain.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=136 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=141 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12	-1.69 Score on a Scale Standard Error 0.271	-2.15 Score on a Scale Standard Error 0.196	-2.14 Score on a Scale Standard Error 0.194

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=136 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=141 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12	-2.90 Score on a Scale Standard Error 0.378	-3.08 Score on a Scale Standard Error 0.273	-3.50 Score on a Scale Standard Error 0.272

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0 to 27. Higher scores indicating more frequent bowel movements.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=136 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=141 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12	-2.38 Score on a Scale Standard Error 0.341	-2.60 Score on a Scale Standard Error 0.246	-2.84 Score on a Scale Standard Error 0.245

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0 to 27. Higher scores indicating more frequent bowel movements.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=136 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=141 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12	-2.27 Score on a Scale Standard Error 0.363	-2.78 Score on a Scale Standard Error 0.262	-2.86 Score on a Scale Standard Error 0.260

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements with blood, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=136 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=141 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12	-2.85 Score on a Scale Standard Error 0.337	-3.50 Score on a Scale Standard Error 0.242	-3.50 Score on a Scale Standard Error 0.240

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=136 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=141 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12	-1.92 Score on a Scale Standard Error 0.234	-2.15 Score on a Scale Standard Error 0.169	0.169 Score on a Scale Standard Error 0.168

SECONDARY outcome

Timeframe: Baseline, Weeks 8 and 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at given categories.

IBDQ was a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 domains: bowel function, emotional status, systemic symptoms, and social function The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. Higher scores indicating a better quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=147 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=144 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 IBDQ Bowel Function Dimension Score: Change at Week 8	11.32 Score on a Scale Standard Error 1.414	16.27 Score on a Scale Standard Error 1.006	15.70 Score on a Scale Standard Error 1.026
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 IBDQ Systemic Symptoms Dimension Score: Change at Week 12	4.44 Score on a Scale Standard Error 0.735	6.19 Score on a Scale Standard Error 0.522	6.72 Score on a Scale Standard Error 0.528
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 IBDQ Bowel Function Dimension Score: Change at Week 12	12.89 Score on a Scale Standard Error 1.568	16.19 Score on a Scale Standard Error 1.114	17.18 Score on a Scale Standard Error 1.127
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 IBDQ Emotional Status Dimension Score: Change at Week 8	9.15 Score on a Scale Standard Error 1.596	14.54 Score on a Scale Standard Error 1.136	14.46 Score on a Scale Standard Error 1.157
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 IBDQ Emotional Status Dimension Score: Change at Week 12	10.10 Score on a Scale Standard Error 1.732	14.62 Score on a Scale Standard Error 1.230	16.01 Score on a Scale Standard Error 1.243
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 IBDQ Systemic Symptoms Dimension Score: Change at Week 8	4.05 Score on a Scale Standard Error 0.681	6.47 Score on a Scale Standard Error 0.485	6.03 Score on a Scale Standard Error 0.494
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 IBDQ Social Function Dimension Score: Change at Week 8	4.89 Score on a Scale Standard Error 0.806	7.59 Score on a Scale Standard Error 0.576	7.14 Score on a Scale Standard Error 0.586
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 IBDQ Social Function Dimension Score: Change at Week 12	6.11 Score on a Scale Standard Error 0.862	7.95 Score on a Scale Standard Error 0.615	8.24 Score on a Scale Standard Error 0.621

SECONDARY outcome

Timeframe: Baseline, Weeks 8 and 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at given categories.

IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 domains: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=147 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=144 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in IBDQ Total Scores at Weeks 8 and 12 Change at Week 8	29.55 Score on a Scale Standard Error 4.205	44.97 Score on a Scale Standard Error 2.999	43.36 Score on a Scale Standard Error 3.053
Change From Baseline in IBDQ Total Scores at Weeks 8 and 12 Change at Week 12	33.52 Score on a Scale Standard Error 4.595	45.00 Score on a Scale Standard Error 3.269	48.12 Score on a Scale Standard Error 3.305

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

SF-36 was a generic quality-of-life instrument that had been widely used to assess health-related quality of life (HRQL) of participants). SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning \[1=yes, limited a lot to 3=no, not limited at all\], role-physical \[1=all of the time to 5=none of the time\], bodily pain \[1=very severe to 6=none\], general health \[1=poor to 5=excellent\], vitality \[1=none of the time to 5=all of the time\], social functioning \[1=all of the time: to 5=none of the time\], role emotional \[1=all of the time to 5=none of the time\] and mental health \[1=all of the time to 5=none of the time\]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The scores ranged from 0 to 100. Higher scores indicating better HRQL.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=141 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=142 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12 Physical Component Summary: Change at Week 12	4.92 Score on a Scale Standard Error 0.848	6.76 Score on a Scale Standard Error 0.604	6.54 Score on a Scale Standard Error 0.610
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12 Mental Component Summary: Change at Week 12	3.89 Score on a Scale Standard Error 1.113	5.83 Score on a Scale Standard Error 0.792	6.37 Score on a Scale Standard Error 0.799

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of participants. The SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning \[1=yes, limited a lot to 3=no, not limited at all\], role-physical \[1=all of the time to 5=none of the time\], bodily pain \[1=very severe to 6=none\], general health \[1=poor to 5=excellent\], vitality \[1=none of the time to 5=all of the time\], social functioning \[1=all of the time: to 5=none of the time\], role emotional \[1=all of the time to 5=none of the time\] and mental health \[1=all of the time to 5=none of the time\]), with scores ranged from 0 to 100. Higher scores indicating better HRQL.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=141 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=142 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12 Physical Functioning: Change at Week 12	4.89 Score on a Scale Standard Error 0.766	5.41 Score on a Scale Standard Error 0.545	4.32 Score on a Scale Standard Error 0.550
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12 Role-Physical: Change at Week 12	3.99 Score on a Scale Standard Error 1.059	6.97 Score on a Scale Standard Error 0.754	7.65 Score on a Scale Standard Error 0.762
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12 Vitality: Change at Week 12	4.96 Score on a Scale Standard Error 1.202	8.08 Score on a Scale Standard Error 0.857	8.69 Score on a Scale Standard Error 0.865
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12 Mental Health: Change at Week 12	3.93 Score on a Scale Standard Error 1.096	5.81 Score on a Scale Standard Error 0.781	6.59 Score on a Scale Standard Error 0.786
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12 Bodily Pain: Change at Week 12	6.28 Score on a Scale Standard Error 1.132	8.83 Score on a Scale Standard Error 0.805	8.50 Score on a Scale Standard Error 0.814
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12 General Health: Change at Week 12	3.36 Score on a Scale Standard Error 0.976	4.78 Score on a Scale Standard Error 0.693	5.36 Score on a Scale Standard Error 0.699
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12 Social Functioning: Change at Week 12	6.07 Score on a Scale Standard Error 1.160	7.80 Score on a Scale Standard Error 0.827	8.56 Score on a Scale Standard Error 0.833
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12 Role-Emotional: Change at Week 12	3.25 Score on a Scale Standard Error 1.082	4.55 Score on a Scale Standard Error 0.765	4.04 Score on a Scale Standard Error 0.772

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.

Number of participants based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and who had undergone gastrointestinal related procedures during the entire study period was reported.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Number of Participants Based on In-patient Hospitalization All-Cause Hospitalization	3 Participants	8 Participants	5 Participants
Number of Participants Based on In-patient Hospitalization Gastrointestinal Related	0 Participants	5 Participants	2 Participants
Number of Participants Based on In-patient Hospitalization Other Illness/Problem	3 Participants	3 Participants	3 Participants
Number of Participants Based on In-patient Hospitalization Undergo Gastrointestinal Related Procedures	0 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

In-patient days were calculated as Date of discharge - Date of admission + 1. Median duration of total inpatient days during the entire study period was reported.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=8 Participants Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=5 Participants Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Median Duration of Total In-patient Days	5.0 Days Interval 3.0 to 7.0	7.0 Days Interval 1.0 to 13.0	4.0 Days Interval 3.0 to 8.0

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Ontamalimab 25 mg

Serious events: 10 serious events

Other events: 20 other events

Deaths: 0 deaths

Ontamalimab 75 mg

Serious events: 8 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=76 participants at risk Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.	Ontamalimab 25 mg n=151 participants at risk Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.	Ontamalimab 75 mg n=151 participants at risk Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Blood and lymphatic system disorders Anaemia	9.2% 7/76 • Number of events 7 • From start of study drug administration up to follow-up (Week 29)	6.6% 10/151 • Number of events 11 • From start of study drug administration up to follow-up (Week 29)	0.66% 1/151 • Number of events 1 • From start of study drug administration up to follow-up (Week 29)
Gastrointestinal disorders Colitis ulcerative	5.3% 4/76 • Number of events 4 • From start of study drug administration up to follow-up (Week 29)	2.0% 3/151 • Number of events 3 • From start of study drug administration up to follow-up (Week 29)	1.3% 2/151 • Number of events 2 • From start of study drug administration up to follow-up (Week 29)
Infections and infestations Nasopharyngitis	2.6% 2/76 • Number of events 2 • From start of study drug administration up to follow-up (Week 29)	6.6% 10/151 • Number of events 10 • From start of study drug administration up to follow-up (Week 29)	2.0% 3/151 • Number of events 3 • From start of study drug administration up to follow-up (Week 29)

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER