Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.

Key facts

Study ID

NCT02780167

Run by

Pfizer

People needed

269

Starts

2016-04-01

Expected to finish

2017-04-01

Last updated by the study team

2019-05-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
• Must have the following atopic dermatitis criteria:
• Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
• Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
• Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).

You may not qualify if…

• History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
• Infected with hepatitis B or hepatitis C viruses.
• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
• Have received any of the following treatment regiments specified in the timeframes outlined below:
• Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.
• Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
• Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.

Where it is running

• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Huntington Medical Foundation — Pasadena, California, United States
• Peninsula Research Associates, Inc. — Rolling Hills Estates, California, United States
• Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery — Sacramento, California, United States
• TCR Medical Corporation — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• University of Connecticut Health Center (UConn Health) — Farmington, Connecticut, United States
• Olympian Clinical Research — Clearwater, Florida, United States
• North Florida Dermatology Associates, PA — Jacksonville, Florida, United States
• Park Avenue Dermatology Administration Annex — Orange Park, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Leavitt Medical Associates of Florida d/b/a Ameriderm Research — Ormond Beach, Florida, United States
• Forward Clinical Trials, Inc. — Tampa, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dawes Fretzin Dermatology Group, LLC — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• DS Research — Louisville, Kentucky, United States
• Shondra L Smith, MD Dermatology & Advanced Aesthetics — Lake Charles, Louisiana, United States
• Somerset Skin Centre — Troy, Michigan, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Clinical Research Consortium — Las Vegas, Nevada, United States
• Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States
• Clinical Research Center of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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