Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
Public ClinicalTrials.gov record NCT03627767. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
Study identification
- NCT ID
- NCT03627767
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,235 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2018 (Actual)
- Primary completion
- Sep 2, 2020 (Actual)
- Completion
- Oct 7, 2020 (Actual)
- Last update posted
- Sep 20, 2021
2018 – 2020
United States locations
- U.S. sites
- 52
- U.S. states
- 22
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | — |
| University of Alabama at Birmingham, Dermatology at the Whitaker Clinic | Birmingham | Alabama | 35233 | — |
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35244 | — |
| Tien Q Nguyen MD Inc dba First OC Dermatology | Fountain Valley | California | 92708 | — |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | — |
| Beach Allergy and Asthma Specialty Group, A Medical Corporation | Long Beach | California | 90808 | — |
| Dermatology Specialists, Inc. | Oceanside | California | 92056 | — |
| University of California San Diego | San Diego | California | 92122 | — |
| San Luis Dermatology and Laser Clinic | San Luis Obispo | California | 93405 | — |
| Southern California Dermatology, Inc. | Santa Ana | California | 92701 | — |
| Mosaic Dermatology | Santa Monica | California | 90403 | — |
| Bay Pines VAHCS | Bay Pines | Florida | 33744 | — |
| Skin Care Research, LLC | Boca Raton | Florida | 33486 | — |
| Skin Research Institute | Coral Gables | Florida | 33146 | — |
| Baumann Cosmetic and Research Institute | Miami | Florida | 33137 | — |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | — |
| USF Asthma, Allergy & Immunology Clinical Research Unit | Tampa | Florida | 33613 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Dermatologic Surgery Specialists, PC | Macon | Georgia | 31217 | — |
| Midwest Allergy Sinus Asthma, SC | Normal | Illinois | 61761 | — |
| NorthShore University HealthSystem Dermatology Clinical Trials Unit | Skokie | Illinois | 60077 | — |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | — |
| Ds Research | New Albany | Indiana | 47150 | — |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | — |
| Kansas City Dermatology, P.A. | Overland Park | Kansas | 66215 | — |
| DXP Imaging | Louisville | Kentucky | 40216 | — |
| Skin Sciences PLLC | Louisville | Kentucky | 40217 | — |
| Qualmedica Research, LLC | Owensboro | Kentucky | 42301 | — |
| Owensboro Dermatology Associates | Owensboro | Kentucky | 42303 | — |
| Meridian Clinical Research, LLC | Baton Rouge | Louisiana | 70808 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | — |
| Saint Louis University Dermatology | St Louis | Missouri | 63104 | — |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11374 | — |
| Juva Skin and Laser Center | New York | New York | 10022 | — |
| UR Dermatology at College Town | Rochester | New York | 14620 | — |
| M3 - Wake Research, Inc. | Raleigh | North Carolina | 27612 | — |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Newton Clinical Research | Oklahoma City | Oklahoma | 73120 | — |
| Oregon Medical Research Center | Portland | Oregon | 97223 | — |
| Paddington Testing Co, Inc. | Philadelphia | Pennsylvania | 19103 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| Dermatology Treatment & Research Center, PA | Dallas | Texas | 75230 | — |
| Innovate Research, LLC | Fort Worth | Texas | 76244 | — |
| The University of Texas Health Science Center Houston | Houston | Texas | 77030 | — |
| Ventavia Research Group Hurst | Hurst | Texas | 76054 | — |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23502 | — |
| Dermatology Associates of Seattle | Seattle | Washington | 98101 | — |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 183 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03627767, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 20, 2021 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03627767 live on ClinicalTrials.gov.