Adults 18 to 75, any sex, with Crohn 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.
Percentage of Participants With Clinical RemissionPrimary· At weeks 48, 96, 144, 192, 240
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\
Number of Participants With Treatment Emergent Adverse Events (TEAEs)Primary· From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)
A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; require
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical RemissionSecondary· At weeks 48, 96, 144, 192, 240
Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. Higher scores indicated worse outcomes.
Percentage of Participants With Clinical ResponseSecondary· At weeks 48, 96, 144, 192, 240
Clinical response is defined as a Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\]
Time frame: Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
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Other Celgene trials
Trials by the same sponsor.
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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 Celgene
Last refreshed: 17 September 2025
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/NCT03467958.