Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03720470 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 838
- Enrollment target
NCT03720470 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 838 participants.
The verdict
NCT03720470, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 838 participants
- Enrollment target
Study Summary
B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy 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. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.
Interventions
- DRUG Dupilumab
- DRUG Oral Placebo
- DRUG PF-04965842 100 mg
- DRUG PF-04965842 200 mg
- DRUG Injectable Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 838 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03720470
The ClinicalTrials.gov registry entry for NCT03720470 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 838 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dupilumab is the first listed.
NCT03720470 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03720470 about?
NCT03720470 is a clinical study titled "Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy". B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 week...
What is the current status of trial NCT03720470?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 838 participants. The study started on 2018-10-29. Estimated completion is 2020-03-06.
What interventions are being tested in trial NCT03720470?
The interventions under investigation include: Dupilumab (DRUG), Oral Placebo (DRUG), PF-04965842 100 mg (DRUG), PF-04965842 200 mg (DRUG), Injectable Placebo (DRUG).
Who is sponsoring clinical trial NCT03720470?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.