Phase 2
N=250
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01287897 ↗Enrolled (actual)
250
Serious AEs
18.2%
Results posted
Jan 2016
Primary outcome: Primary: The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg — 30.6; 35.0; 49.3 Percentage of participants — p=0.3406
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04236921 SC injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg |
30.6; 35.0; 49.3 | 0.3406 |
| PRIMARY The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg |
28.8; 39.0 | 0.2258 |
| PRIMARY The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg |
28.6; 35.2; 47.4 | 0.2627 |
| PRIMARY The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg |
26.7; 41.7 | 0.1362 |
| SECONDARY The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg |
12.3; 19.4; 18.1; 16.5; 34.6; 37.0 | 0.1527 |
| SECONDARY The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg |
11.2; 26.5; 15.2; 24.6; 19.5; 27.2 | 0.0662 |
| SECONDARY The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg |
1.6; 3.6; 9.6; 3.4; 4.1; 19.7 | 0.2610 |
| SECONDARY The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg |
1.1; 6.9; 2.4; 5.1; 6.1; 8.8 | 0.1342 |
| SECONDARY The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg |
12.4; 16.7; 12.6; 13.0; 18.1; 26.3 | 0.2687 |
| SECONDARY The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg |
10.3; 12.0; 11.0; 22.1; 12.2; 22.2 | 0.4031 |
| SECONDARY Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg |
-18.9; -28.4; -16.2; -25.1; -37.1; -50.7 | 0.2173 |
| SECONDARY Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg |
-21.3; -30.1; -26.6; -30.5; -36.7; -42.2 | 0.3157 |
| SECONDARY Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs) |
0.0; 0.0; 0.0; 0.0; 1.6; 0.0 | — |
| SECONDARY Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs) |
0.0; 0.0; 0.0; 0.0; 1.6; 0.0 | — |
| SECONDARY Serum PF-04236921 Concentration Over Time |
4.52; 2.05; NA; 1060; 4580; 21300 | — |
| SECONDARY Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs) |
7; 6; 6; 8; 0; 0 | — |
Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Eligibility Criteria
Inclusion Criteria
- Subjects must have failed or are intolerant to anti TNFs
- hsCRP greater or equal to 5.0 mg/L
- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening
Exclusion Criteria
- Pregnant or breastfeeding women
- Crohn's Disease with active fistulae or abscess
- History of diverticulitis or symptomatic diverticulosis
- Abnormality in hematology or chemistry profiles at screening
Data sourced from ClinicalTrials.gov (NCT01287897). 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.