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An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03252587
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : February 28, 2022
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: BMS-986165 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Actual Study Start Date : September 21, 2017
Actual Primary Completion Date : June 29, 2021
Actual Study Completion Date : October 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1 oral administration Drug: BMS-986165
Specified dose on specified days

Experimental: BMS-986165 Dose 2 oral administration Drug: BMS-986165
Specified dose on specified days

Experimental: BMS-986165 Dose 3 oral administration Drug: BMS-986165
Specified dose on specified days

Placebo Comparator: Placebo oral administration Other: Placebo
Specified dose on specified days

Primary Outcome Measures :
  1. Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [ Time Frame: At Week 32 ]

Secondary Outcome Measures :
  1. Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [ Time Frame: At Week 48 ]
  2. Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: At Week 48 ]
  3. Number of participants who achieve Lupus Low Disease Activity State (LLDAS) [ Time Frame: At Week 48 ]
  4. Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline achieving a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score [ Time Frame: At Week 48 ]
  5. Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [ Time Frame: At Week 48 ]
  6. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 56 weeks ]
  7. Incidence of adverse events (AEs) [ Time Frame: Up to 52 weeks ]
  8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 56 weeks ]
  9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 56 weeks ]
  10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 56 weeks ]
  11. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 56 weeks ]
  12. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 56 weeks ]
  13. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 56 weeks ]
  14. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 56 weeks ]
  15. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [ Time Frame: Up to 52 weeks ]
  16. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 48 weeks ]
  17. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 48 weeks ]
  18. Trough observed plasma concentration (Ctrough) [ Time Frame: Up to 48 weeks ]
  19. Change in mean and median interferon-regulated gene (IRG) expression levels [ Time Frame: Up to 52 weeks ]
  20. Change in mean complement (C3, C4) and anti-double-stranded DNA (dsDNA) levels [ Time Frame: Up to 52 weeks ]
  21. Assess the effect of BMS-986165 on measures of global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (ie, high versus low IRG signature) [ Time Frame: Up to 52 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit
  • Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
  • One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
  • Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash [score must be confirmed by Central Review Services (CRS)]
  • Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
  • SLE overlap syndromes such as scleroderma and mixed connective tissue disease
  • Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)
  • History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03252587

Hide Hide 192 study locations
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United States, Alabama
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States, 35233
United States, Arkansas
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States, 72205
United States, California
TriWest Research Associates
El Cajon, California, United States, 92020
BioSolutions Clinical Research Center
La Mesa, California, United States, 91942
Los Angeles County Hospital and University of Southern California Medical Center
Los Angeles, California, United States, 90033
University of California at Irvine College of Medicine
Orange, California, United States, 92868
Desert Medical Advances
Palm Desert, California, United States, 92260
Millennium Clinical Trials - Thousand Oaks
Thousand Oaks, California, United States, 91360
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Inland Rheumatology Clinical Trials
Upland, California, United States, 91786
United States, Connecticut
University of Connecticut Health Center - New England Musculoskeletal Institute - Farmington
Farmington, Connecticut, United States, 06030-5353
Yale University
New Haven, Connecticut, United States, 06520-8018
United States, Florida
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States, 33511
University of Florida Health Shands Hospital
Gainesville, Florida, United States, 32610
Omega Research Group - Orlando
Orlando, Florida, United States, 32808
Millennium Research
Ormond Beach, Florida, United States, 32174-1139
West Broward Rheumatology Associates
Tamarac, Florida, United States, 33321
Advent Health Medical Group
Tampa, Florida, United States, 33613
BayCare Medical Group
Tampa, Florida, United States, 33614
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
Jefrey D. Lieberman, MD., PC
Decatur, Georgia, United States, 30033
North Georgia Rheumatology Group-Duluth
Lawrenceville, Georgia, United States, 30045
Arthritis Research and Treatment Center
Stockbridge, Georgia, United States, 30281
United States, Maryland
Klein & Associates
Cumberland, Maryland, United States, 21502
Klein and Associates
Hagerstown, Maryland, United States, 21740
United States, Michigan
Advanced Rheumatology - Lansing
Lansing, Michigan, United States, 48910
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455-0341
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New York
Weill Cornell Physicians at Brooklyn
Brooklyn, New York, United States, 11201
SUNY Downstate Health Science University
Brooklyn, New York, United States, 11203
Northwell Health
Lake Success, New York, United States, 11042
New York University School of Medicine
New York, New York, United States, 10016
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Thurston Arthritis Research Center
Chapel Hill, North Carolina, United States, 27599-7280
Joint and Muscle Research Institute
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
United States, Texas
Austin Regional Clinic
Austin, Texas, United States, 78731-3146
Tekton Research - Austin
Austin, Texas, United States, 78745
Pioneer Research Solutions
Cypress, Texas, United States, 77429-5890
Baylor Research Institute
Dallas, Texas, United States, 75231
UTSW Medical Center
Dallas, Texas, United States, 75390
Accurate Clinical Management - Greenhouse Road
Houston, Texas, United States, 77084
Accurate Clinical Research
Houston, Texas, United States, 77089
Southwest Rheumatology Research
Mesquite, Texas, United States, 75150
Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas, United States, 78232
United States, Virginia
The Center for Arthritis and Rheumatic Diseases
Chesapeake, Virginia, United States, 23320
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Arthritis Northwest, PLLC
Spokane, Washington, United States, 99204
Investigaciones Reumatologicas y Osteologicas SRL
Caba, Buenos Aires, Argentina, C1114AAF
Clinica Adventista Belgrano
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430
Aprillus Asistencia e Investigacion
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1046AAQ
Consultorios Medicos Doctor Catalan Pellet
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1111AAL
Maffei Centro Medico
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AGC
Instituto CAICI
Rosario, Santa FE, Argentina, 2000
Centro Medico Privado de Reumatologia
San Miguel De Tucum, Tucuman, Argentina, T4000AXL
Consultora Integral de Salud - Centro Medico Privado
Cordoba, Argentina, X5004FHP
Hospital Privado Centro Medico de Cordoba
Cordoba, Argentina, X5016KEH
Instituto de Reumatologia
Mendoza, Argentina, 5500
Australia, Queensland
Rheumatology Research Unit - Maroochydore
Maroochydore, Queensland, Australia, 4558
Australia, Victoria
Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia, 3081
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, Bahia, Brazil, 40150150
CIP - Centro Internacional de Pesquisa
Goiania, Goias, Brazil, 74110-120
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil, 30150-223
Centro Mineiro de Pesquisa - CMiP
Juiz de Fora, Minas Gerais, Brazil, 36010-570
CETI-UFPR Centro de Estudos em Terapias Inovadoras
Curitiba, Parana, Brazil, 80030-110
Hospital de Clinicas de Porto Alegre
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
LMK Servicos Medicos S/S Ltda
Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
Centro Multidisciplinar de Estudos Clinicos
Sao Bernardo do Campo, SAO Paulo, Brazil, 09715-090
CITIPA - Centro de Imunoterapia de Ipanema
Rio de Janeiro, Brazil, 22221-020
CPCLIN - Centro de Pesquisas Clinicas
Sao Paulo, Brazil, 01228-200
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2G3
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8S 4K1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Centro Integral de Reumatologia Circaribe
Barranquilla, Colombia, 080002
Centro de Investigacion Medico Asistencial CIMEDICAL
Barranquilla, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
Bogota, Colombia
Medicity SAS
Bucaramanga, Colombia, 680003
Clinica de Artritis Temprana
Cali, Colombia
Preventive Care
Chia, Colombia, 250001
Healthy Medical Center
Zipaquira, Colombia, 250252
Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi
Berlin, Germany, D-10117
Klinik fur Nieren- und Hochdruckerkrankungen
Hannover, Germany, 30625
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin
Mainz, Germany, 55131
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, Hungary, 1097
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, Hungary, 5700
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary, 6725
Local Institution
Haifa, Israel, 33394
Local Institution
Jerusalem, Israel, 9122001
Local Institution
Kfar Saba, Israel, 4428164
Local Institution
Petah Tikva, Israel, 4941492
Local Institution
Tel-Hashomer, Israel, 52621
National Hospital Organization Chibahigashi National Hospital
Chiba-shi, Chiba, Japan, 260-8712
Kameda Clinic
Kamogawa-shi, Chiba, Japan, 296-0041
Hospital of the University of Occupational and Environmental Health Japan
Kitakyushu, Fukuoka, Japan, 807-8556
Sapporo City General Hospital
Sapporo-shi, Hokkaido, Japan, 0608604
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Tohoku University Hospital
Sendai City, Miyagi, Japan, 980-8574
Tomishiro Central Hospital
Tomigusuku-shi, Okinawa, Japan, 9010243
Dokkyo Medical University
Shimotsuga-gun, Tochigi, Japan, 3210293
Jichi Medical University Hospital
Shimotsuke-city, Tochigi, Japan, 329-0498
St Lukes International Hospital
Chuo-ku, Tokyo, Japan, 104-8560
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 1738610
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan, 1608582
Kanazawa University Hospital
Ishikawa, Japan, 920-8641
Juntendo University Hospital
Tokyo, Japan, 113-8431
Showa University Hospital
Tokyo, Japan, 142-8666
National Hospital Organization Tokyo Medical Center
Tokyo, Japan, 152-8902
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Japan, 162-8655
Korea, Republic of
Local Institution
Daegu, Korea, Republic of, 41944
Local Institution
Daegu, Korea, Republic of, 42601
Local Institution
Daejeon, Korea, Republic of, 35015
Local Institution
Gwangju, Korea, Republic of, 61469
Local Institution
Incheon, Korea, Republic of, 400-711
Local Institution
Seoul, Korea, Republic of, 110-774
Local Institution
Suwon, Korea, Republic of, 16499
Centro de Investigacion y Tratamiento Reumatologico
Mexico City, Distrito Federal, Mexico, 11850
CAIMED Investigacion en Salud
Mexico, Distrito Federal, Mexico, 06760
Consultorio Medico de Reumatologia
Leon, Guanajuato, Guanajuato, Mexico, 37000
Centro de Investigacion Farmacologica del Bajio
Leon, Guanajuato, Mexico, 37160
Centro Integral de Reumatologia
Guadalajara, Jalisco, Mexico, 44160
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, Mexico, 45070
Juan Alberto Rodriguez Ruiz
Zapopan, Jalisco, Mexico, 45116
Accelerium Clinical Research
Monterrey, Nuevo LEON, Mexico, 64000
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
San Luis Potosi, Mexico, 78213
Faicic S. de R.L. de C.V.
Veracruz, Mexico, 91900
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, Poland, 85-168
Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C
Bytom, Poland, 41-902
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, Poland, 82-300
Centrum Medyczne Pratia w Gdyni
Gdynia, Poland, 81-338
Silmedic Sp. z o.o.
Katowice, Poland, 40-282
Zespol Opieki Zdrowotnej w Konskich
Konskie, Poland, 26-200
Koscian, Poland, 64-000
Centrum Medyczne Plejady
Krakow, Poland, 30-363
Centrum Nowoczesnych Terapii Dobry Lekarz Spolka z ograniczona odpowiedzialnoscia
Krakow, Poland, 31-011
Centrum Medyczne ProMiMed
Krak, Poland, 31-637
REUMED Sp. z o.o.
Lublin, Poland, 20-607
Medyczne Centrum Hetmanska - Poznan
Poznan, Poland, 60-218
Solumed Centrum Medyczne
Poznan, Poland, 60-529
Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia
Poznan, Poland, 60-693
Centrum Medyczne Medens - Grupowa Praktyka Lekarska
Sosnowiec, Poland, 41-200
SANUS Szpital Specjalistyczny
Stalowa Wola, Poland, 37-450
Medycyna Kliniczna
Warszawa, Poland, 00-660
Centrum Medyczne Pratia Warszawa
Warszawa, Poland, 01-868
Ars Rheumatica - Reumatika Centrum Reumatologii
Warszawa, Poland, 02-691
Centrum Medyczne AMED Warszawa Targowek
Warszawa, Poland, 03-291
Synexus Polska - Wroclaw
Wroclaw, Poland, 50-363
Wroclaw, Poland, 51-685
Centrum Medyczne Oporow
Wroclaw, Poland, 52-416
Neomed Research
Brasov, Romania, 500283
Centrul Medical Sana
Bucuresti, Romania, 011025
Spitalul Sfanta Maria
Bucuresti, Romania, 011172
Spitalul Clinic Dr. Ioan Cantacuzino
Bucuresti, Romania, 020475
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, Romania, 400006
Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei
Galati, Romania, 800578
Spitalul Judetean de Urgenta Valcea
Ramnicu Valcea, Romania, 240277
Russian Federation
Ekaterinburg, Russian Federation, 620043
Kemerovo State Medical University
Kemerovo, Russian Federation, 650000
Medical Center Maksimum Zdorovia
Kemerovo, Russian Federation, 650066
Medical Center Health Family
Novosibirsk, Russian Federation, 630099
Orenburg State Medical University
Orenburg, Russian Federation, 460018
State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
Petrozavodsk, Russian Federation, 185019
Military Medical Academy S.M. Kirov
Saint - Petersburg, Russian Federation, 191045
Clinical Rheumatological Hospital Number 25
Saint Petersburg, Russian Federation, 190068
Polyclinic of Private Security Personnel
Saint Petersburg, Russian Federation, 192007
Private Healthcare Institution Clinical Hospital
Smolensk, Russian Federation, 214025
Federal Almazov North-West Medical Research Centre
St. Petersburg, Russian Federation, 197341
Tolyatti city clinical hospital ߵ
Tolyatti, Russian Federation, 445039
Vladimir, Russian Federation, 600005
Clinical Hospital named after NA Semashko
Yaroslavl, Russian Federation, 150002
State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2
Yaroslavl, Russian Federation, 150030
Complejo Hospitalario Universitario A Coruna
A Coru, Spain, 15006
Hospital Universitari Vall dHebron
Barcelona, Spain, 08035
Hospital Regional Universitario de Malaga Hospital General
Malaga, Spain, 29010
Hospital de Merida
Merida, Spain, 06800
Corporacio Sanitaria Parc Tauli
Sabadell, Spain, 08208
Hospital Universitario Nuestra Senora de Valme
Sevilla, Spain, 41014
Local Institution
Changhua City, Taiwan, 500
Local Institution
Taichung, Taiwan, 40201
Local Institution
Taipei City, Taiwan, 10630
Local Institution
Taipei, Taiwan, 10002
Local Institution
Taipei, Taiwan, 110
Local Institution
Taipei, Taiwan, 11217
Local Institution
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb Identifier: NCT03252587    
Other Study ID Numbers: IM011-021
2017-001203-79 ( EudraCT Number )
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action