Phase 1
Completed N=49
Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs
Crohn's Disease · Ileitis · Ileo-colonic and Colonic Crohn's Disease · Granulomatous Colitis
Source: ClinicalTrials.gov NCT01387594 ↗
Enrolled (actual)
49
Serious AEs
8.2%
Results posted
Apr 2017
Primary outcomePrimary: Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF) — 338.5 cells per milliliter (cells/mL)
Summary
Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF) |
338.5 | — |
| PRIMARY Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3 |
35.2 | — |
| SECONDARY Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period |
9; 36; 0; 0; 1; 3 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 |
4; 11 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity |
1; 6; 0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- males and females >=18 and = 5 mg/L and Harvey-Bradshaw Index > 8 OR when HBI cannot be determined (ie if stoma is present) or hsCRP 3 months; must have endoscopy to confirm active disease during screening; total mayo score of 6 to 12 points and moderate to severe disease on endoscopy
Exclusion Criteria
- Pregnancy or breastfeeding
- TB or active enteric infections
- Entero vesicular fistulae
- Prior use of natalizumab or vedolizumab
- Right or left heart failure including symptomatic diastolic dysfunction or unexplained elevation of troponin I (>0.05 ng/mL)
Data sourced from ClinicalTrials.gov (NCT01387594). 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.