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NCT03349060 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 387
- Enrollment target
NCT03349060: Completed Phase 3 study, sponsored by Pfizer.
NCT03349060 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 387 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03349060, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 387 participants
- Enrollment target
Study Summary
B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.
Primary Outcome
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3
Interventions
- DRUG Placebo
- DRUG PF-04965842 100 mg
- DRUG PF-04965842 200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 387 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2019-03-26 |
| Phase | Phase 3 |
What the finished NCT03349060 record still lists
NCT03349060 is an interventional study that assigns participants to a tested intervention. The registered 387 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03349060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03349060 about?
NCT03349060 is a clinical study titled "Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis". B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated rela...
What is the current status of trial NCT03349060?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 387 participants. The study started on 2017-12-07. Estimated completion is 2019-03-26.
What interventions are being tested in trial NCT03349060?
The interventions under investigation include: Placebo (DRUG), PF-04965842 100 mg (DRUG), PF-04965842 200 mg (DRUG).
Who is sponsoring clinical trial NCT03349060?
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 NCT03349060's enrollment target sits among peer trials
387 973rd of 2000 higher than 1,028 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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