Trial · NCT03259334

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

NCT03259334, Phase 3, Terminated, Shire; results first posted 2021-05-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis. Trials, record NCT03259334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03259334

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
NCT number: NCT03259334
Status: Terminated
Phases: Phase 3
Enrollment: 380 participants, actual
Lead sponsor: Shire
Conditions: Ulcerative Colitis
Interventions: Ontamalimab, Placebo
First posted: 2017-08-23
Last updated: 2021-06-14
Other registries' IDs: eudract:2017-000599-27
Results first posted: 2021-05-07
Limitations and caveats: The study was terminated early as per the sponsor decision to discontinue the ontamalimab clinical trial development program for inflammatory bowel diseases (IBD) for reasons unrelated to safety and efficacy.

Source ClinicalTrials.gov

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Remission at Week 12	At Week 12	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).
Secondary	Number of Participants With Endoscopic Remission at Week 12	At Week 12	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.
Secondary	Number of Participants With Clinical Remission at Week 12	At Week 12	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.
Secondary	Number of Participants With Clinical Response Based on Composite Score at Week 12	At Week 12	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).
Secondary	Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12	At Week 12	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.
Secondary	Number of Participants With Remission Based on Total Mayo Score at Week 12	At Week 12	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).
Secondary	Number of Participants With Clinical Response Based on Total Mayo Score at Week 12	At Week 12	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).
Secondary	Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12	At Weeks 4, 8, and 12	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.
Secondary	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 Weeks 4 and 8	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
Secondary	Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12	At Week 12	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.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Remission at Week 12	At Week 12	Full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Endoscopic Remission at Week 12	At Week 12	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinical Remission at Week 12	At Week 12	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinical Response Based on Composite Score at Week 12	At Week 12	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12	At Week 12	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Remission Based on Total Mayo Score at Week 12	At Week 12	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinical Response Based on Total Mayo Score at Week 12	At Week 12	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12	At Weeks 4, 8, and 12	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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 Weeks 4 and 8	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12	At Week 12	FAS consisted of all participants in the randomized set who had received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group144

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Remission at Week 12	Placebo	12	Participants
Number of Participants With Remission at Week 12	Ontamalimab 25 mg	28	Participants
Number of Participants With Remission at Week 12	Ontamalimab 75 mg	45	Participants
Number of Participants With Endoscopic Remission at Week 12	Placebo	16	Participants
Number of Participants With Endoscopic Remission at Week 12	Ontamalimab 25 mg	42	Participants
Number of Participants With Endoscopic Remission at Week 12	Ontamalimab 75 mg	62	Participants
Number of Participants With Clinical Remission at Week 12	Placebo	29	Participants
Number of Participants With Clinical Remission at Week 12	Ontamalimab 25 mg	61	Participants
Number of Participants With Clinical Remission at Week 12	Ontamalimab 75 mg	76	Participants
Number of Participants With Clinical Response Based on Composite Score at Week 12	Placebo	34	Participants

1 to 10 of 144Source ClinicalTrials.gov

See all 144 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	76
Overall Study	STARTED	Ontamalimab 25 mg	153
Overall Study	STARTED	Ontamalimab 75 mg	151
Overall Study	Treated	Placebo	76
Overall Study	Treated	Ontamalimab 25 mg	151
Overall Study	Treated	Ontamalimab 75 mg	151
Overall Study	COMPLETED	Placebo	66
Overall Study	COMPLETED	Ontamalimab 25 mg	136
Overall Study	COMPLETED	Ontamalimab 75 mg	138
Overall Study	NOT COMPLETED	Placebo	10

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events57

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Placebo	7	76	7
other	Anaemia	Blood and lymphatic system disorders	Ontamalimab 25 mg	10	151	11
other	Anaemia	Blood and lymphatic system disorders	Ontamalimab 75 mg	1	151	1
other	Colitis ulcerative	Gastrointestinal disorders	Placebo	4	76	4
other	Colitis ulcerative	Gastrointestinal disorders	Ontamalimab 25 mg	3	151	3
other	Colitis ulcerative	Gastrointestinal disorders	Ontamalimab 75 mg	2	151	2
other	Nasopharyngitis	Infections and infestations	Placebo	2	76	2
other	Nasopharyngitis	Infections and infestations	Ontamalimab 25 mg	10	151	10
other	Nasopharyngitis	Infections and infestations	Ontamalimab 75 mg	3	151	3
serious	Anaemia	Blood and lymphatic system disorders	Placebo	2	76	2

1 to 10 of 57Source ClinicalTrials.gov

See all 57 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	76
Total, all-cause mortality	Ontamalimab 25 mg	0	151
Total, all-cause mortality	Ontamalimab 75 mg	1	151
Total, other adverse events	Placebo	10	76
Total, other adverse events	Ontamalimab 25 mg	20	151
Total, other adverse events	Ontamalimab 75 mg	6	151
Total, serious adverse events	Placebo	5	76
Total, serious adverse events	Ontamalimab 25 mg	10	151
Total, serious adverse events	Ontamalimab 75 mg	8	151

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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