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NCT03395184 · ClinicalTrials.gov registry record · Phase 2
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 244
- Enrollment target
NCT03395184: Completed Phase 2 study, sponsored by Pfizer.
NCT03395184 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 244 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03395184, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 244 participants
- Enrollment target
Study Summary
The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.
Primary Outcome
SES CD50 was defined as 50% improvement from baseline in SES-CD. Baseline was defined as last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=
Interventions
- DRUG PF-06651600
- DRUG PF-06700841
- DRUG PF-06651600 Placebo
- DRUG Placebo PF-06700841
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2023-10-19 |
| Phase | Phase 2 |
What the finished NCT03395184 record still lists
NCT03395184 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 4 interventions - of which PF-06651600 is the first listed.
NCT03395184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03395184 about?
NCT03395184 is a clinical study titled "Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease". The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, fol...
What is the current status of trial NCT03395184?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2018-02-02. Estimated completion is 2023-10-19.
What interventions are being tested in trial NCT03395184?
The interventions under investigation include: PF-06651600 (DRUG), PF-06700841 (DRUG), PF-06651600 Placebo (DRUG), Placebo PF-06700841 (DRUG).
Who is sponsoring clinical trial NCT03395184?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03395184's enrollment target sits among peer trials
244 235th of 2000 higher than 1,765 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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