Trial · NCT03627091
Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
NCT03627091, Phase 3, Terminated, Shire; results first posted 2022-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307). Trials, record NCT03627091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03627091
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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 Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
- NCT number
- NCT03627091
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Shire
- Conditions
- Crohn's Disease
- Interventions
- Ontamalimab, Placebo
- First posted
- 2018-08-13
- Last updated
- 2022-03-31
- Other registries' IDs
- eudract:2017-000617-23
- Results first posted
- 2022-03-31
- Limitations and caveats
- The study was closed early as the sponsor discontinued the ontamalimab clinical trial program in CD for reasons unrelated to safety or efficacy.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Remission at Week 52 | At Week 52 | Clinical remission was defined by 2-item PRO sub-scores 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 52 or discontinuation before Week 52 were considered failures. Number of participants with clinical remission at Week 52 were reported. |
| Primary | Number of Participants With Enhanced Endoscopic Response at Week 52 | At Week 52 | Enhanced endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 50 percent (%) from induction study (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\] 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 52 or who discontinued before Week 52 were considered non responders. Number of participants with enhanced endoscopic response at Week 52 were reported. |
| Secondary | Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52 | At Week 52 | Clinical remission was defined as a CDAI score of \<150. CDAI assessed 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. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission as measured by CDAI at Week 52 were reported. |
| Secondary | Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 | At Week 52 | Glucocorticoid-free clinical remission defined as clinical remission by 2-item PRO not requiring any treatment with glucocorticoids for at least 12 weeks prior to Week 52 visit. Clinical remission defined by 2-item PRO sub-scores of average worst daily abdominal pain \<=3 (based on 11 point 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 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 sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were non-responders. Number of participants with glucocorticoid-free clinical remission response at Week 52 were reported. |
| Secondary | Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52 | At Week 52 | Clinical remission was defined by CD daily e-diary 2-item PRO subscores 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 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission based on Crohn's Disease (CD) e-diary Sub-scores for abdominal pain was was reported. |
| Secondary | Number of Participants With Sustained Clinical Remission at Week 52 | At Week 52 | Sustained clinical remission was defined as clinical remission by 2-item PRO at both Week 52 visit and the maintenance baseline in this Study. Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (\<=) 3 (based on 11 point 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 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). Number of participants with sustained clinical remission at Week 52 were reported. |
| Secondary | Number of Participants With Sustained Enhanced Endoscopic Response at Week 52 | At Week 52 | Sustained enhanced endoscopic response was defined as enhanced endoscopic response at both Week 52 visit and the maintenance baseline in this study. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50 % from induction study (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]) 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. Number of participants with sustained enhanced endoscopic response at Week 52 were reported. |
| Secondary | Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52 | At Week 52 | Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain \<=3 (based on 11-point NRS) over the 7 most recent days and average daily stool frequency \<= 2 of Type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50% from induction study (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]) baseline. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non-responders. |
| Secondary | Number of Participants With Complete Endoscopic Healing at Week 52 | At Week 52 | Complete endoscopic healing was defined as SES-CD scale score from 0-2. 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 52 or who discontinued before Week 52 were considered failures. Number of participants with complete endoscopic healing at Week 52 were reported. |
Source ClinicalTrials.gov
Outcomes9
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 at Week 52 | At Week 52 | The full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of investigational product (IP) in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Enhanced Endoscopic Response at Week 52 | At Week 52 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52 | At Week 52 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 | At Week 52 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52 | At Week 52 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Clinical Remission at Week 52 | At Week 52 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Enhanced Endoscopic Response at Week 52 | At Week 52 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52 | At Week 52 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Endoscopic Healing at Week 52 | At Week 52 | The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group27
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 at Week 52 | Placebo | 2 | Participants | ||
| Number of Participants With Clinical Remission at Week 52 | Ontamalimab 25 mg | 3 | Participants | ||
| Number of Participants With Clinical Remission at Week 52 | Ontamalimab 75 mg | 5 | Participants | ||
| Number of Participants With Enhanced Endoscopic Response at Week 52 | Placebo | 2 | Participants | ||
| Number of Participants With Enhanced Endoscopic Response at Week 52 | Ontamalimab 25 mg | 4 | Participants | ||
| Number of Participants With Enhanced Endoscopic Response at Week 52 | Ontamalimab 75 mg | 6 | Participants | ||
| Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52 | Placebo | 8 | Participants | ||
| Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52 | Ontamalimab 25 mg | 4 | Participants | ||
| Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52 | Ontamalimab 75 mg | 7 | Participants | ||
| Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 | Placebo | 2 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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 | 19 | |
| Overall Study | STARTED | Ontamalimab 25 mg | 10 | |
| Overall Study | STARTED | Ontamalimab 75 mg | 11 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | COMPLETED | Ontamalimab 25 mg | 4 | |
| Overall Study | COMPLETED | Ontamalimab 75 mg | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Ontamalimab 25 mg | 6 | |
| Overall Study | NOT COMPLETED | Ontamalimab 75 mg | 5 |
Source ClinicalTrials.gov
Adverse events153
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 | Leukocytosis | Blood and lymphatic system disorders | Placebo | 0 | 19 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Ontamalimab 25 mg | 1 | 10 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Ontamalimab 75 mg | 0 | 11 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 19 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ontamalimab 25 mg | 0 | 10 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ontamalimab 75 mg | 1 | 11 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 1 | 19 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Ontamalimab 25 mg | 0 | 10 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Ontamalimab 75 mg | 0 | 11 | 0 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Placebo | 0 | 19 | 0 |
1 to 10 of 153Source ClinicalTrials.gov
See all 153 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 19 |
| Total, all-cause mortality | Ontamalimab 25 mg | 0 | 10 |
| Total, all-cause mortality | Ontamalimab 75 mg | 0 | 11 |
| Total, other adverse events | Placebo | 9 | 19 |
| Total, other adverse events | Ontamalimab 25 mg | 5 | 10 |
| Total, other adverse events | Ontamalimab 75 mg | 8 | 11 |
| Total, serious adverse events | Placebo | 1 | 19 |
| Total, serious adverse events | Ontamalimab 25 mg | 0 | 10 |
| Total, serious adverse events | Ontamalimab 75 mg | 2 | 11 |
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/NCT03627091
GET https://conductscience.org/api/trials/v1/NCT03627091/results?page=2