Adults 16 to 80, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16Primary· 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-
Group
Value
95% CI
Placebo
3
Ontamalimab 25 mg
5
Ontamalimab 75 mg
5
Number of Participants With Endoscopic Response at Week 16Primary· 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.
Group
Value
95% CI
Placebo
2
Ontamalimab 25 mg
10
Ontamalimab 75 mg
10
Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16Secondary· 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
Group
Value
95% CI
Placebo
4
Ontamalimab 25 mg
8
Ontamalimab 75 mg
6
Number of Participants With Enhanced Endoscopic Response at Week 16Secondary· 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.
Group
Value
95% CI
Placebo
2
Ontamalimab 25 mg
5
Ontamalimab 75 mg
3
Number of Participants With Clinical Remission Based on 2-item PRO With 4-point Scale for Abdominal Pain at Week 16Secondary· 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 sto
Group
Value
95% CI
Placebo
3
Ontamalimab 25 mg
6
Ontamalimab 75 mg
6
Number of Participants With Clinical Response Based on 2-item PRO With 2 Criteria at Week 16Secondary· 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
Group
Value
95% CI
Placebo
5
Ontamalimab 25 mg
11
Ontamalimab 75 mg
8
Number of Participants With Clinical Remission Based on 2-Item PRO With Endoscopic Response at Week 16Secondary· 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
Group
Value
95% CI
Placebo
1
Ontamalimab 25 mg
4
Ontamalimab 75 mg
5
Number of Participants With Complete Endoscopic Healing at Week 16Secondary· 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
Group
Value
95% CI
Placebo
1
Ontamalimab 25 mg
3
Ontamalimab 75 mg
2
Adverse events — posted to ClinicalTrials.gov
Time frame: From screening up to safety follow-up period (Week 32).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07052682 — A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepat
· Phase 1
· terminated
NCT03627091 — Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Diseas
· Phase 3
· terminated
NCT03559517 — Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (C
· Phase 3
· terminated
NCT03290781 — An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Co
· Phase 3
· completed
NCT03259334 — Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
· Phase 3
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 11 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03566823.