18 and older, 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.
Proportion of Patients With Steroid Free Clinical Remission and Fecal Calprotectin<250µg/g at Week 48Primary· week 48
Proportion of patients with steroid free clinical remission (patient reported outcome-2 remission: abdominal pain ≤ 1 AND stool frequency ≤ 3) and fecal calprotectin\<250µg/g at week 48. \[stool frequency (ST): average number of liquid stools for 1 week abdominal pain (AP): average scoring for abdominal pain for 1 week (0=none; 1=mild, 2=moderate; 3= severe)\]
Group
Value
95% CI
Ustekinumab q4w
8
Ustekinumab q8w
10
Proportion of Patients With Complete Endoscopic Remission at Week 48Secondary· week 48
Proportion of patients with complete endoscopic remission (simple endoscopic score for Crohn's disease (SES-CD )\<3) at week 48
Group
Value
95% CI
Ustekinumab q4w
4
Ustekinumab q8w
3
Proportion of Patients With Endoscopic Remission at Week 48Secondary· week 48
Proportion of patients with endoscopic remission (simple endoscopic score for Crohn's disease (SES-CD) \<5) at week 48
Group
Value
95% CI
Ustekinumab q4w
15
Ustekinumab q8w
8
Proportion of Patients With Endoscopic Response at Week 48Secondary· week 48
Proportion of patients with endoscopic response (≥50% decrease in simple endoscopic score for Crohn's disease (SES-CD)) at week 48
Group
Value
95% CI
Ustekinumab q4w
12
Ustekinumab q8w
8
Proportion of Patients With Clinical Remission at Week 8Secondary· week 8
Proportion of patients with clinical remission (patient reported outcome-2 remission: abdominal pain ≤ 1 AND stool frequency ≤ 3) at week 8
Group
Value
95% CI
Ustekinumab q4w
19
Ustekinumab q8w
21
Proportion of Patients With Clinical Remission at Week 48Secondary· week 48
Proportion of patients with clinical remission (patient reported outcome-2 remission: abdominal pain ≤ 1 AND stool frequency ≤ 3) at week 48
Group
Value
95% CI
Ustekinumab q4w
16
Ustekinumab q8w
18
Proportion of Patients With Biomarker Remission at Week 48Secondary· week 48
Proportion of patients with biomarker remission (C-reactive protein \<5 mg/L and fecal calprotectin \<250 µg/g) at week 48
Group
Value
95% CI
Ustekinumab q4w
18
Ustekinumab q8w
13
Proportion of Patients With Serious Adverse Events at Week 48Secondary· Week 48
Proportion of patients with serious adverse events at week 48
Group
Value
95% CI
Ustekinumab q4w
9
Ustekinumab q8w
7
Adverse events — posted to ClinicalTrials.gov
Time frame: From signature of informed consent form up to week 48 in the study. For SAE's up to 60 days after the last study treatment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn's disease who show a secondary loss of response over time
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07268534 — Biologics in Folliculitis Decalvans : an Adaptative Trial Research
· Phase 2
· not yet recruiting
NCT06807593 — Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
· Phase 2
· recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT07177118 — Risankizumab for Fibrostenotic Crohn's Disease Treatment
· Phase 3
· not yet recruiting
NCT07116967 — Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
· Phase 3
· recruiting
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat
· Phase 2
· recruiting
NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
· Phase 4
· recruiting
NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
· recruiting
NCT07170462 — Cranberry and Gut Health in Crohn's Disease
· EARLY_PHASE1
· recruiting
NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
· Phase 2, PHASE3
· recruiting
Other Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW trials
Trials by the same sponsor.
NCT05992142 — ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA
· Phase 4
· completed
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 Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Last refreshed: 13 April 2026
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/NCT04245215.