A Phase 2 interventional study of PF-04236921 and PF-04236921 in Crohn's Disease, sponsored by Pfizer. Completed at 127 sites in 16 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 191 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: PF-04236921
Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.
Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.
Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
Time frame: Baseline up to Week 48
Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (\>=) 4.32. Any positive ADA sample was further tested for NAbs.
Time frame: At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.
| Milestone | PF-04236921 |
|---|---|
| Started | 191 |
| Completed | 111 |
| Not completed | 80 |
| Withdrew: Adverse event | 16 |
| Withdrew: Lack of efficacy | 17 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 41 |
| Withdrew: Other | 3 |
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
| participants | PF-04236921 |
|---|---|
| Participants with AEs | 171 |
| Participants with SAEs | 58 |
| Participants discontinued due to AEs | 54 |
Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (\>=) 4.32. Any positive ADA sample was further tested for NAbs.
| percentage of participants | PF-04236921 |
|---|---|
| ADA positive | 0.52 |
| NAbs positive | 0.52 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PF-04236921 | — | 79/191 (41.4%) | 150/191 (78.5%) |
| Event | PF-04236921 |
|---|---|
| Crohn's diseaseGastrointestinal disorders | 41/191 |
| Anal fistulaGastrointestinal disorders | 4/191 |
| Abdominal abscessInfections and infestations | 4/191 |
| Small intestinal perforationGastrointestinal disorders | 3/191 |
| Fistula of small intestineGastrointestinal disorders | 2/191 |
| Rectal haemorrhageGastrointestinal disorders | 2/191 |
| Small intestinal obstructionGastrointestinal disorders | 2/191 |
| CholecystitisHepatobiliary disorders | 2/191 |
| Cytomegalovirus infectionInfections and infestations | 2/191 |
| PneumoniaInfections and infestations | 2/191 |
| Event | PF-04236921 |
|---|---|
| Crohn's diseaseGastrointestinal disorders | 45/191 |
| Abdominal painGastrointestinal disorders | 39/191 |
| NasopharyngitisInfections and infestations | 31/191 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 23/191 |
| HeadacheNervous system disorders | 23/191 |
| VomitingGastrointestinal disorders | 22/191 |
| NauseaGastrointestinal disorders | 21/191 |
| DiarrhoeaGastrointestinal disorders | 20/191 |
| RashSkin and subcutaneous tissue disorders | 18/191 |
| Urinary tract infectionInfections and infestations | 16/191 |
Included all participants who received at least 1 dose of study treatment during the study B0151005
| Age, Continuous(years) | PF-04236921 |
|---|---|
| Mean | 40.1 ± 12.9 |
| Sex: Female, Male(Participants) | PF-04236921 |
|---|---|
| FEMALE | 108 |
| MALE | 83 |
Showing the first 100 of 127 sites across 16 countries.
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