Phase 2
Completed N=84
Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT01284062 ↗
Enrolled (actual)
84
Serious AEs
16.7%
Results posted
Nov 2014
Primary outcomePrimary: Fold Change From Baseline in Fecal Calprotectin at Week 14 — 0.41; 0.29; 0.79; 1.24 fold change — p=0.5320
Summary
This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fold Change From Baseline in Fecal Calprotectin at Week 14 |
0.41; 0.29; 0.79; 1.24 | 0.5320 |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab |
54480; 101200; 182200; 68270; 121400; 197600 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab |
0.0000; 42.45; 51.19; 13310; 22350; 31120 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab |
8346000; 14670000; 24430000 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) for Anrukinzumab |
392.4; 470.5; 362.4 | — |
| SECONDARY Systemic Clearance (CL) for Anrukinzumab |
0.2844; 0.3090; 0.3789 | — |
| SECONDARY Volume of Distribution (Vz) for Anrukinzumab |
5.726; 9.704; 6.143 | — |
| SECONDARY Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12 |
0.70; 0.81; 0.71; 0.77; 0.92; 0.47 | 0.7352 |
| SECONDARY Total Interleukin-13 (IL-13) Level |
0.6247; 1.6231; 1.2900; 0.7525; 0.5980; 3.6373 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
15; 19; 17; 17; 4; 4 | — |
| SECONDARY Number of Participants Who Discontinued From the Study Due to Adverse Events |
4; 5; 1; 5 | — |
| SECONDARY Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14 |
6; 8; 11; 2; 3; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female, Age >=18 and <=65 years
- Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score
- women of childbearing potential with highly effective method of contraception
Exclusion Criteria
- Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.
Data sourced from ClinicalTrials.gov (NCT01284062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.