Phase 2
N=262
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01276509 ↗Enrolled (actual)
262
Serious AEs
15.3%
Results posted
Apr 2017
Primary outcome: Primary: Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate — 52.7; 60.1; 62.7; 47.7 Percentage of Participants — p=0.3393
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-00547659 SC injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate |
52.7; 60.1; 62.7; 47.7; 62.0; 64.7 | 0.3393 |
| SECONDARY Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo |
57; 51; 54; 54; 20; 24 | — |
| SECONDARY Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo |
175; 192; 192; 141; 40; 55 | — |
| SECONDARY Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission |
29.1; 23.8; 26.9; 16.7; 26.8; 28.5 | 0.1234 |
| SECONDARY Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time |
35.1; 22.4; 33.8; 35.5; 38.0; 39.5 | — |
| SECONDARY Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer |
19.3; 18.4; 20.0; 18.5; 29.2; 32.3 | — |
| SECONDARY Immunogenicity Assessment of Anti-drug Antibodies (ADAs) |
3; 5; 1; 2; 4; 2 | — |
| SECONDARY The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) |
615300; 4464000; 13760000 | — |
| SECONDARY The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau) |
549500; 4214000; 10850000 | — |
| SECONDARY The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax) |
1756; 10800; 24100 | — |
| SECONDARY The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax) |
140; 143; 165 | — |
| SECONDARY The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf) |
4.977; 8.770; 12.22 | — |
| SECONDARY The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F) |
36.54; 16.79; 16.38 | — |
Summary
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
Eligibility Criteria
Inclusion Criteria
- Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
- hsCRP greater than 3mg/L
- Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening
Exclusion Criteria
- Pregnant or breast feeding
- Short bowel syndrome due to multiple small bowel resections
- Presence of a stoma
Data sourced from ClinicalTrials.gov (NCT01276509). 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.