Trial · NCT03566823
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
NCT03566823, Phase 3, Terminated, Shire; results first posted 2021-05-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306). Trials, record NCT03566823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03566823
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
- NCT number
- NCT03566823
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- Shire
- Conditions
- Crohn's Disease
- Interventions
- Ontamalimab, Placebo
- First posted
- 2018-06-25
- Last updated
- 2021-05-11
- Results first posted
- 2021-05-11
- Limitations and caveats
- The study was terminated as the sponsor discontinued the ontamalimab clinical trial program in ulcerative colitis and CD for reasons unrelated to safety.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16 | At Week 16 | Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain less than or equal to (\<=) 3 (based on 11 point numerical rating scale \[NRS\] ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]); and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 16 or discontinuation before Week 16 were considered failures. Number of participants with clinical remission were reported. |
| Primary | Number of Participants With Endoscopic Response at Week 16 | At Week 16 | Endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 25 percent (%) from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with endoscopic response were reported. |
| Secondary | Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16 | At Week 16 | Clinical remission was defined as a CDAI score of \<150. CDAI assesses CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, \>451 points: severely active to fulminant disease. Higher score indicating more severity. Number of participants with clinical remission as measured by CDAI were reported. |
| Secondary | Number of Participants With Enhanced Endoscopic Response at Week 16 | At Week 16 | Enhanced endoscopic response was defined as a decrease in SES-CD by matching segments of at least 50% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered non-responders. Number of participants with enhanced endoscopic response were reported. |
| Secondary | Number of Participants With Clinical Remission Based on 2-item PRO With 4-point Scale for Abdominal Pain at Week 16 | At Week 16 | Clinical remission was defined by 2-item PRO subs-cores of average daily abdominal pain \<=1 (based on the 4 point scale, with scores ranging from 0 \[none\] to 3 \[severe\]) over the 7 most recent days and average daily stool frequency \<=3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with enhanced endoscopic response were reported. |
| Secondary | Number of Participants With Clinical Response Based on 2-item PRO With 2 Criteria at Week 16 | At Week 16 | Clinical response was measured by 2-item PRO and defined as meeting at least 1 of the following 2 criteria: 1)A decrease of greater than or equal to (\>=) 30% and at least 2 points from baseline in the average daily worst abdominal pain over the 7 most recent days, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either a) not worsening from baseline and/or b) average daily stool frequency \<=2 of type 6/7 as per the BSFS over the 7 most recent days; 2)A decrease of \>=30% from baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days, with the average daily worst abdominal pain either a) not worsening from baseline and/or b) worst daily abdominal pain \<=3 (based on 11-point NRS) over the 7 most recent days. Participants with missing data at Week16 or who discontinued before Week 16 were considered failures. Number of participants with clinical response were reported. |
| Secondary | Number of Participants With Clinical Remission Based on 2-Item PRO With Endoscopic Response at Week 16 | At Week 16 | Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain \<=3 (based on 11 point NRS ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]) over the 7 most recent days and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per BSFS ranging from type 1 (separate hard lumps-like stools) to type 7 (entirely liquid stools) over the 7 most recent days. Endoscopic response was defined as a decrease in SES CD of at least 25% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with clinical remission and endoscopic response were reported. |
| Secondary | Number of Participants With Complete Endoscopic Healing at Week 16 | At Week 16 | Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain \<=3 (based on 11 point NRS ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]) over the 7 most recent days and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per BSFS ranging from type 1 (separate hard lumps-like stools) to type 7 (entirely liquid stools) over the 7 most recent days. Endoscopic response was defined as a decrease in SES CD of at least 25% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with complete endoscopic healing were reported. |
| Secondary | Number of Participants With Clinical Response as Measured by CDAI-100 at Week 16 | At Week 16 | Clinical response was measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response). CDAI assesses CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, \>451 points: severely active to fulminant disease. Higher score indicating more severity. |
| Secondary | Number of Participants With Clinical Response as Measured by CDAI-70 at Week 16 | At Week 16 | Clinical response was measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response). CDAI assesses CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, \>451 points: severely active to fulminant disease. Higher score indicating more severity. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16 | At Week 16 | The full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Endoscopic Response at Week 16 | At Week 16 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16 | At Week 16 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Enhanced Endoscopic Response at Week 16 | At Week 16 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on 2-item PRO With 4-point Scale for Abdominal Pain at Week 16 | At Week 16 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response Based on 2-item PRO With 2 Criteria at Week 16 | At Week 16 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on 2-Item PRO With Endoscopic Response at Week 16 | At Week 16 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Endoscopic Healing at Week 16 | At Week 16 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response as Measured by CDAI-100 at Week 16 | At Week 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Number of Participants With Clinical Response as Measured by CDAI-70 at Week 16 | At Week 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group24
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 Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16 | Placebo | 3 | Participants | ||
| Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16 | Ontamalimab 25 mg | 5 | Participants | ||
| Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16 | Ontamalimab 75 mg | 5 | Participants | ||
| Number of Participants With Endoscopic Response at Week 16 | Placebo | 2 | Participants | ||
| Number of Participants With Endoscopic Response at Week 16 | Ontamalimab 25 mg | 10 | Participants | ||
| Number of Participants With Endoscopic Response at Week 16 | Ontamalimab 75 mg | 10 | Participants | ||
| Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16 | Placebo | 4 | Participants | ||
| Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16 | Ontamalimab 25 mg | 8 | Participants | ||
| Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16 | Ontamalimab 75 mg | 6 | Participants | ||
| Number of Participants With Enhanced Endoscopic Response at Week 16 | Placebo | 2 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | STARTED | Ontamalimab 25 mg | 15 | |
| Overall Study | STARTED | Ontamalimab 75 mg | 13 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | COMPLETED | Ontamalimab 25 mg | 12 | |
| Overall Study | COMPLETED | Ontamalimab 75 mg | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Ontamalimab 25 mg | 3 | |
| Overall Study | NOT COMPLETED | Ontamalimab 75 mg | 2 |
Source ClinicalTrials.gov
Adverse events129
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 | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Ontamalimab 25 mg | 2 | 15 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Ontamalimab 75 mg | 0 | 13 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 6 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ontamalimab 25 mg | 1 | 15 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ontamalimab 75 mg | 1 | 13 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Ontamalimab 25 mg | 0 | 15 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Ontamalimab 75 mg | 1 | 13 | 2 |
| other | Anal fistula | Gastrointestinal disorders | Placebo | 0 | 6 | 0 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, all-cause mortality | Ontamalimab 25 mg | 0 | 15 |
| Total, all-cause mortality | Ontamalimab 75 mg | 0 | 13 |
| Total, other adverse events | Placebo | 6 | 6 |
| Total, other adverse events | Ontamalimab 25 mg | 6 | 15 |
| Total, other adverse events | Ontamalimab 75 mg | 5 | 13 |
| Total, serious adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Ontamalimab 25 mg | 2 | 15 |
| Total, serious adverse events | Ontamalimab 75 mg | 2 | 13 |
Source ClinicalTrials.gov
Papers1
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03566823
GET https://conductscience.org/api/trials/v1/NCT03566823/results?page=2