Results from a Phase 2/3 trial (NCT03759288) investigating brazikumab in participants with moderately to severely active Crohn's disease, with adalimumab (Humira) as an active comparator, were posted on 2026-06-23. The terminated study reported serum brazikumab concentrations, with mean values ranging from approximately 0 ng/mL to 509242.871 ng/mL across different dose groups and measurements.
Background
Crohn's disease is a chronic inflammatory bowel disease (IBD) affecting the digestive tract. Adalimumab (Humira) was included in this study as an active comparator.
Trial design
This was a Phase 2/3 study (NCT03759288) that enrolled 89 participants with moderately to severely active Crohn's Disease. The trial evaluated brazikumab at low and high doses against placebo and an active comparator, adalimumab (Humira). The study's overall status was TERMINATED. No primary outcomes were reported in the posted results.
Key results
The trial reported serum concentrations of brazikumab across different dose groups:
- For Brazikumab Low Dose, mean serum concentration was 0 ng/mL (Standard Deviation: 0 ng/mL).
- For Brazikumab High Dose, mean serum concentration was 0 ng/mL (Standard Deviation: 0 ng/mL).
- Another measurement for Brazikumab Low Dose showed a mean of 39740.393 ng/mL (Standard Deviation: 16831.393 ng/mL).
- For Brazikumab High Dose, a mean of 84159.863 ng/mL (Standard Deviation: 45498.163 ng/mL) was observed.
- Further data for Brazikumab Low Dose indicated a mean of 237241.760 ng/mL (Standard Deviation: 176335.398 ng/mL).
- For Brazikumab High Dose, a mean of 509242.871 ng/mL (Standard Deviation: 340284.089 ng/mL) was reported.
- Another measurement for Brazikumab Low Dose showed a mean of 60889.921 ng/mL (Standard Deviation: 31963.196 ng/mL).
- For Brazikumab High Dose, a mean of 126727.906 ng/mL (Standard Deviation: 50760.775 ng/mL) was observed.
- A subsequent measurement for Brazikumab Low Dose indicated a mean of 38736.890 ng/mL (Standard Deviation: 24390.374 ng/mL).
- For Brazikumab High Dose, a mean of 64005.344 ng/mL (Standard Deviation: 32966.081 ng/mL) was reported.
- Another measurement for Brazikumab Low Dose showed a mean of 32301.477 ng/mL (Standard Deviation: 27986.448 ng/mL).
- For Brazikumab High Dose, a mean of 31530.520 ng/mL (Standard Deviation: 19209.280 ng/mL) was observed.
What this means
The posted results provide pharmacokinetic data for brazikumab, detailing its serum concentrations at various points in the study. These measurements are crucial for understanding drug exposure. However, as the trial was TERMINATED and no efficacy or safety outcomes were reported, these results alone do not provide insights into the clinical effectiveness or safety profile of brazikumab for Crohn's Disease. The termination of the study suggests a halt in its development for this indication, pending further analysis or strategic decisions.
Source
The trial results were posted on 2026-06-23 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT03759288.