Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis
NCT ID: NCT02581345
Last Updated: 2018-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
572 participants
INTERVENTIONAL
2015-09-30
2017-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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M923
Participants assigned to receive M923
M923
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Humira
Participants assigned to receive Humira
Humira
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
M923 and Humira
Participants assigned to receive M923 and Humira
M923
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Humira
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Interventions
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M923
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Humira
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic plaque-type psoriasis diagnosed for at least 6 months before screening
3. Stable plaque psoriasis
4. History of receipt of or candidate for therapy.
5. Moderate to severe psoriasis at screening and baseline
6. Must be willing and able to self-administer SC injections or have a caregiver available to administer injections
7. Male participants of childbearing potential must employ a highly effective contraceptive measure
8. Female participants must have a negative pregnancy test; are not planning to become pregnant; and must not be lactating. Female participants must also agree to employ a highly effective contraceptive measure.
Exclusion Criteria
2. Drug-induced psoriasis.
3. Other skin conditions which would interfere with assessment of psoriasis
4. Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening
5. Other inflammatory conditions other than psoriasis or psoriatic arthritis
6. Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies
7. Ongoing use of prohibited psoriasis treatments
8. Ongoing use of other non-psoriasis prohibited treatments
9. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks
10. Laboratory abnormalities at screening deemed clinically significant by the investigator
11. Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk
12. History of latex allergy
13. History of or current signs or symptoms or diagnosis of a demyelinating disorder
14. History of or current Class III or IV New York Heart Association congestive heart failure
15. Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
16. Current malignancy or history of any malignancy except adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ; no more than 3 lifetime basal cell and squamous cell carcinomas permitted
17. Chronic infections, recurrent infections; recent infection to be evaluated
18. History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or C virus (HCV)
19. History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
20. Exposure to an investigational product ≤30 days prior to enrollment or participation in another clinical study during the course of this study
21. Participant is a family member or employee of the investigator or site staff or study team
18 Years
ALL
No
Sponsors
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Momenta Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Caminis, MD
Role: STUDY_DIRECTOR
Shire
Locations
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Wallace Medical Group, Inc.
Beverly Hills, California, United States
Encino Research Center
Encino, California, United States
eStudySite
La Mesa, California, United States
eStudySite
Oceanside, California, United States
eStudySite
San Diego, California, United States
Shahram Jacobs MD, INC
Sherman Oaks, California, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
Bioclinical Research Alliance; Inc
Miami, Florida, United States
Sanitas Reasearch, LLC
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Radiant Research; Inc.
Overland Park, Kansas, United States
Tufts Medical Center; Inc.
Boston, Massachusetts, United States
Bay State Clinical Trials, Inc
Watertown, Massachusetts, United States
eStudySite
Las Vegas, Nevada, United States
Radiant Research; Inc.
Cincinnati, Ohio, United States
Radiant Research, Inc.
Columbus, Ohio, United States
Radiant Clinical Research
Anderson, South Carolina, United States
Palmetto Clinical Trial Services, LLC
Fountain Inn, South Carolina, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Austin Institute for Clinical Research, LLC
Pflugerville, Texas, United States
Clinical Trials of Texas; Inc.
San Antonio, Texas, United States
National Clinical Research-Richmond, Inc
Richmond, Virginia, United States
Medical Centre Asklepii, OOD
Dupnitsa, , Bulgaria
DCC Sveti Georgi EOOD
Haskovo, , Bulgaria
UMHAT Dr.Georgi Stranski, EAD
Pleven, , Bulgaria
DCC Sv. Georgi, EOOD
Plovdiv, , Bulgaria
Department of Dermatology and Venereology, Faculty of Medicine, UMHAT Alexandrovska
Sofia, , Bulgaria
Mediprobe Research Inc
London, Ontario, Canada
SKDS Research Inc
Newmarket, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Office of Dr. Michael Robern
Ottawa, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
K Papp Clinical Research Inc
Waterloo, Ontario, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Dr. David Gratton Dermatologue Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Ste-Foy, Quebec, Canada
CCBR Czech Prague s.r.o
Prague, Czech Republic, Czechia
Dermatologie - MUDr. HELENA KORANDOVA s.r.o.
Olomouc, Povel, Czechia
CCBR Czech Brno, s.r.o
Brno, , Czechia
CCBR Czech a.s
Pardubice, , Czechia
Clintrial s.r.o
Prague, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
MUDr. Jaroslav Dragon - Kozni ordinace
Ústí nad Labem, , Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem Dermatovenerologicke oddeleni
Ústí nad Labem, , Czechia
Parnu Hospital
Pärnu, , Estonia
Vahlberg & Pild OU
Tallinn, , Estonia
East Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Medicum AS
Tallinn, , Estonia
Kliiniliste Uuringute Keskus (Clinical Research Centre)
Tartu, , Estonia
Tartu University Hospital; Dermatology Clinic
Tartu, , Estonia
Universitaetsklinikum Schleswig Holstein
Schleswig, Holstein, Germany
Klinische Forschunq Schwerin GmbH
Dorf Mecklenburg, Vorpommern, Germany
Praxis fuer Dermatologie und Venerologie
Dresden, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, , Germany
Clinical Research Hamburg
Hamburg, , Germany
Riga 1 st Hospital
Riga, , Latvia
Derma Clinic Riga Ltd
Riga, , Latvia
Health Centre 4
Riga, , Latvia
J. Kisis Ltd
Riga, , Latvia
Health Centre 4
Riga, , Latvia
Ventspils Outpatient Clinic
Ventspils, , Latvia
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw, Masovian Voivodeship, Poland
Poradnia Kardiologiczna Jaroslaw Jurowiecki
Gdansk, , Poland
Medica Pro Familia Sp. z o. o. S.K.A. Oddzial w Gdyni
Gdynia, , Poland
NZOZ POLIMEDICA FILIA KIELCE (Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA)
Kielce, , Poland
Medica Pro Familia Sp. z o.o. SK.A.
Krakow, , Poland
Grazyna Pulka Specjalistyczny Osrodek ALL-MED
Krakow, , Poland
Centrum Terapii Wspolczesnej _J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
Lodz, , Poland
Centrum Medyczne Szpital Swietej Rodziny
Lodz, , Poland
NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
Lodz, , Poland
KO-MED Centra Kliniczne Lublin II
Lublin, , Poland
Medicome sp.zoo
Oświęcim, , Poland
Centrum Badan Klinicznych S.C.
Poznan, , Poland
Ai Centrum Medyczne
Poznan, , Poland
KO-MED Centra Kliniczne Pulawy
Puławy, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
NZOZ Nasz Lekarz
Torun, , Poland
MTZ Clinical Research Sp z o.o.
Warsaw, , Poland
KO-MED Centra Kliniczne Zamosc
Zamość, , Poland
Nzoz Polimedica
Zgierz, , Poland
Pedi-Derma s.r.o.
Košice, Košice Region, Slovakia
Derma therapy spol. s.r.o.
Bratislava, , Slovakia
Nemocnica Kosice-Saca, a.s., 1.sukromna nemocnica
Košice, , Slovakia
Dema-beauty, s.r.o
Nitra, , Slovakia
Sanare S.r.o
Svidník, , Slovakia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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911401
Identifier Type: -
Identifier Source: org_study_id
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