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May 3, June 20, July 19, August 22, August 23, September 19, November 25, February 20, March 19, April 1, April 28, May 28, June 15, June 29, July 16, August 11, September 11, October 1, October 28, Study Status Record Verification:. FDA-regulated Drug:. Study Description Brief Summary:. B is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study.
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The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country.
Conditions Conditions:.
Study Design Study Type:. Drug: Abrocitinib mg In the initial treatment period, Abrocitinib mg, administered as two tablets to be taken orally once daily. Drug: Placebo For subjects whose dose was changed from mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study. Drug: Abrocitinib mg In the secondary treatment period, Abrocitinib mg, administered as one tablet to be taken orally once daily.
Drug: Abrocitinib mg For subjects whose dose was changed from mg Abrocitinib to mg PF, one tablet will be administered to be taken orally once daily for the remainder of the study. Drug: Abrocitinib mg In the secondary treatment period, Abrocitinib mg, administered as two tablets to be taken orally once daily. Outcome Measures Primary Outcome Measures:. Treatment emergent adverse events The incidence of treatment emergent adverse events [Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years].
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Serious adverse events and adverse events leading to discontinuation The incidence of serious adverse events and adverse events leading to discontinuation [Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years]. Change from baseline in clinical laboratory values Change from baseline in clinical laboratory values [Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years].
Change from baseline in electrocardiogram ECG measurements Change from baseline in electrocardiogram ECG measurements [Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years]. Change from baseline in vital signs Change from baseline in vital signs [Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years].
Body Surface Area BSA affected Change from baseline in the percentage BSA affected at all scheduled time points [Time Frame: Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years]. Eligibility Minimum Age:. Pfizer CT. Emmaus Research Center, Inc. Tilda Research Inc. Dermatology Specialists, Inc. Peninsula Research Associates, Inc. University Clinical Trials lnc. Southern California Dermatology, Inc. Moonshine Research Center, Inc. Clinical Neuroscience Solutions, Inc.
Solutions Through Advanced Research, Inc. La Salud Research Clinic, Inc. Qualmedica Research, LLC. Chesapeake Clinical Research, Inc. Clinical Research Institute, Inc. M3-Wake Research, Inc. Carolina Research Center, Inc. Paddington Testing Co, Inc. Arlington Research Center, Inc. Austin Institute for Clinical Research, Inc. Psoriahue Medicina Interdisciplinaria [Recruiting] C. Skin Health Institute Inc. MHAT ''Dr. Dermatology Clinic "Sofia" - group practice for specialized outpatient medical care [Recruiting] Sofia, Bulgaria, Pacific Dermaesthetics Inc. Wiseman Dermatology Research Inc.
Karma Clinical Trials, Inc. Lynderm Research Inc. North York Research Inc. Manna Research Inc. Innovaderm Research Inc. Diex Research Sherbrooke Inc. Clinica Dermacross S. Kozni ambulance Kutna Hora, s. Lekarna, Nemocnice Pardubickeho kraje, a. Nemocnice Pardubickeho kraje, a. Sanatorium profesora Arenbergera [Recruiting] Praha 1, Czechia, Dermatovenerologicka ambulance [Recruiting] Svitavy, Czechia, Krajska zdravotni a.
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Lekarna Masarykovy nemocnice v Usti nad Labem, o. Universitätsklinikum Erlangen [Recruiting] Erlangen, Germany, Praxis Dr. Beate Schwarz [Recruiting] Langenau, Germany, Dermatologische Gemeinschaftspraxis [Recruiting] Mahlow, Germany, Universitätsklinikum Marburg [Recruiting] Marburg, Germany, Hautaerztliche Gemeinschaftspraxis Dres.
Leitz und Kollegen [Recruiting] Stuttgart, Germany, Intézete [Recruiting] Budapest, Hungary, Synexus Magyarország Egészségügyi Szolgáltató Kft. Trial Pharma Kft. Universita degli Studi G. Sanrui Hifuka [Active, not recruiting] Saitama, Japan, Severance Hospital, Yonsei Univ.
Aesthetic dermatology clinic of Prof. Health Centre 4 Ltd. Clinical Research Institute Saltillo S. Derma Norte del Bajio S. Servicios Hospitalarios de Mexico S. Phylasis Clinicas Research S. Hospital de Jesus, I. Cryptex Investigación Clínica, S. Trials in Medicine S. Eukarya Pharmasite S. SMIQ, S. Sociedad de Metabolismo y Corazon S.
Synexus Polska Sp. Oddzial w Czestochowie [Recruiting] Czestochowa, Poland, Copernicus Podmiot Leczniczy Sp. Neutrum Lekarze M. Oddzial w Gdyni [Recruiting] Gdynia, Poland, Oddzial w Katowicach [Recruiting] Katowice, Poland, Silmedic Sp. Pro Familia Altera Sp. Krakowskie Centrum Medyczne Sp. Centrum Terapii Wspolczesnej J. Dermoklinika-Centrum Medyczne s.
Lesiak [Recruiting] Lodz, Poland, Oddzial w Poznaniu [Recruiting] Poznan, Poland, Successful requests will fall within both the current eligibility guidelines and funding priority areas established by the Amgen Foundation. The Amgen Foundation has established grantmaking partnerships with qualified intermediary partners to manage donations to organizations chartered outside of the U.
Please review the Letter of Inquiry Checklist and the Grant Application Checklist to verify the information that you will need to provide as part of your grant proposal. No, Return to Amgen. Yes, Leave Amgen. Organizations may only submit one request a year for funding. The Foundation's review committees meet quarterly. Paper forms will not be evaluated.