Trial · NCT03290781
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
NCT03290781, Phase 3, Completed, Shire; results first posted 2022-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis. Trials, record NCT03290781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03290781
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
- NCT number
- NCT03290781
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 366 participants, actual
- Lead sponsor
- Shire
- Conditions
- Ulcerative Colitis
- Interventions
- Ontamalimab, Placebo
- First posted
- 2017-09-25
- Last updated
- 2022-01-14
- Other registries' IDs
- eudract:2017-000573-37
- Results first posted
- 2022-01-14
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Remission Based on Composite Score at Week 52 | At Week 52 | Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease). |
| Secondary | Number of Participants With Endoscopic Remission at Week 52 | At Week 52 | Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration). |
| Secondary | Number of Participants With Clinical Remission at Week 52 | At Week 52 | Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and 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 Sustained Remission at Week 52 | At Week 52 | Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease). |
| Secondary | Number of Participants With Clinical Response Based on Composite Score at Week 52 | At Week 52 | Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding \>=1 point or a sub-score for rectal bleeding \<= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood \& 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease. |
| Secondary | Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52 | At Week 52 | Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of \<=2. The centrally read endoscopic sub-score of mayo score ranges 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 = 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 indicates more severe disease. |
| Secondary | Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 | At Week 52 | Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood \& 3=blood alone passes). |
| Secondary | Number of Participants With Glucocorticoid-free Remission at Week 52 | At Week 52 | Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. |
| Secondary | Number of Participants With Remission Based on Total Mayo Score at Week 52 | At Week 52 | Remission defined as a total mayo score of less than or equal to (\<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy \[modified, excludes friability\], and physician's global assessment) exceeding 1. The total mayo score ranges 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: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease \[spontaneous bleeding, ulceration\]. |
| Secondary | Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0 | At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 Based on Composite Score at Week 52 | At Week 52 | The ontamalimab responder full analysis set (FAS) consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Endoscopic Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder FAS only (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response Based on Composite Score at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Glucocorticoid-free Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Remission Based on Total Mayo Score at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0 | At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group127
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Remission Based on Composite Score at Week 52 | ONTA 25 mg/ Placebo | 6 | Participants | ||
| Number of Participants With Remission Based on Composite Score at Week 52 | ONTA 25 mg/ONTA 25 mg | 38 | Participants | ||
| Number of Participants With Remission Based on Composite Score at Week 52 | ONTA 75 mg/Placebo | 11 | Participants | ||
| Number of Participants With Remission Based on Composite Score at Week 52 | ONTA 75 mg/ONTA 75 mg | 33 | Participants | ||
| Number of Participants With Endoscopic Remission at Week 52 | ONTA 25mg/Placebo | 7 | Participants | ||
| Number of Participants With Endoscopic Remission at Week 52 | ONTA 25mg/ONTA 25mg | 40 | Participants | ||
| Number of Participants With Endoscopic Remission at Week 52 | ONTA 75mg/Placebo | 13 | Participants | ||
| Number of Participants With Endoscopic Remission at Week 52 | ONTA 75mg/ONTA 75mg | 40 | Participants | ||
| Number of Participants With Clinical Remission at Week 52 | ONTA 25mg/Placebo | 13 | Participants | ||
| Number of Participants With Clinical Remission at Week 52 | ONTA 25mg/ONTA 25mg | 48 | Participants |
1 to 10 of 127Source ClinicalTrials.gov
See all 127 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ONTA 25mg/ Placebo | 73 | |
| Overall Study | STARTED | ONTA 25mg/ONTA 25mg | 71 | |
| Overall Study | STARTED | ONTA 75mg/Placebo | 86 | |
| Overall Study | STARTED | ONTA 75mg/ONTA 75mg | 82 | |
| Overall Study | STARTED | Placebo/Placebo | 11 | |
| Overall Study | STARTED | Placebo/ONTA 25mg | 22 | |
| Overall Study | STARTED | Placebo/ONTA 75mg | 21 | |
| Overall Study | COMPLETED | ONTA 25mg/ Placebo | 24 | |
| Overall Study | COMPLETED | ONTA 25mg/ONTA 25mg | 53 | |
| Overall Study | COMPLETED | ONTA 75mg/Placebo | 30 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events371
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 | ONTA 25mg/ Placebo | 2 | 73 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | ONTA 25mg/ONTA 25mg | 4 | 71 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | ONTA 75mg/Placebo | 3 | 86 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | ONTA 75mg/ONTA 75mg | 1 | 82 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo/Placebo | 1 | 11 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo/ONTA 25mg | 0 | 22 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo/ONTA 75mg | 0 | 21 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | ONTA 25mg/ Placebo | 0 | 73 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | ONTA 25mg/ONTA 25mg | 0 | 71 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | ONTA 75mg/Placebo | 1 | 86 | 1 |
1 to 10 of 371Source ClinicalTrials.gov
See all 371 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ONTA 25mg/ Placebo | 0 | 73 |
| Total, all-cause mortality | ONTA 25mg/ONTA 25mg | 0 | 71 |
| Total, all-cause mortality | ONTA 75mg/Placebo | 1 | 86 |
| Total, all-cause mortality | ONTA 75mg/ONTA 75mg | 0 | 82 |
| Total, all-cause mortality | Placebo/Placebo | 1 | 11 |
| Total, all-cause mortality | Placebo/ONTA 25mg | 0 | 22 |
| Total, all-cause mortality | Placebo/ONTA 75mg | 0 | 21 |
| Total, other adverse events | ONTA 25mg/ Placebo | 41 | 73 |
| Total, other adverse events | ONTA 25mg/ONTA 25mg | 27 | 71 |
| Total, other adverse events | ONTA 75mg/Placebo | 52 | 86 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38096402 | DERIVED |
Source PubMed
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.
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.
For software
Read this trial from software.
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