Adults 18 to 70, 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.
Crohn's Disease Activity Index (CDAI) ScorePrimary· Week 16
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit.
A CDAI score of less than 150 is considered to be clinical remission.
Group
Value
95% CI
IV Weight-Based Induction Dose
84.67
± 64.82
Standard Subcutaenous Dose
33.3
± 47.14
Number of Patients With a Clinical ResponseSecondary· Week 16
A clinical response is defined as a drop in CDAI score by at least 100 points between week 0 and week 16, or a CDAI \< 150.
Group
Value
95% CI
IV Weight-Based Induction Dose
3
Standard Subcutaenous Dose
3
Number of Patients With a Composite Clinical and Biomarker RemissionSecondary· Week 16
Defined as a CDAI \< 150 and a C-reactive protein (CRP) \<5mg/l or a fecal calprotectin \<150 ug/g
Group
Value
95% CI
IV Weight-Based Induction Dose
2
Standard Subcutaenous Dose
2
Change in Crohn's Disease Activity Index (CDAI) ScoreSecondary· Week 0, Week 16
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit.
A CDAI score of less than 150 is considered to be clinical remission, a score greater than 220 is considered to define moderate to severe disease, and a score greater than 300 is considered to be severe disease.
Group
Value
95% CI
IV Weight-Based Induction Dose
158
± 52.14
Standard Subcutaenous Dose
251
± 39.13
Number of Patients With Improvement in Health-related Quality of LifeSecondary· Week 16
Defined as increase in SIBDQ by at least 9 points between week 0 and week 16.
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a 10-item health-related quality of life (HRQoL) questionnaire validated for use in CD patients. It assesses 4 domains: physical, social, emotional, and systemic and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). The absolute score ranges from 10 (poor HRQOL) to 70 (optimum HRQOL).
Group
Value
95% CI
IV Weight-Based Induction Dose
3
Standard Subcutaenous Dose
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
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· recruiting
NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
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· recruiting
NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
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NCT07170462 — Cranberry and Gut Health in Crohn's Disease
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· recruiting
NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
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· recruiting
Other NYU Langone Health 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 NYU Langone Health
Last refreshed: 5 November 2024
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/NCT04629196.