Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis

Last updated: October 15, 2018
Sponsor: Momenta Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Warts

Psoriasis And Psoriatic Disorders

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT02581345
911401
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic plaque-type psoriasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must be able to understand and communicate with the investigator and comply with therequirements of the study

  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 caregiveravailable to administer injections

  7. Male participants of childbearing potential must employ a highly effectivecontraceptive measure

  8. Female participants must have a negative pregnancy test; are not planning to becomepregnant; and must not be lactating. Female participants must also agree to employ ahighly effective contraceptive measure.

Exclusion

Exclusion Criteria:

  1. Forms of psoriasis other than chronic plaque-type

  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 usedin 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-TNFbiologic 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 atleast 4 weeks

  10. Laboratory abnormalities at screening deemed clinically significant by theinvestigator

  11. Any condition or illness which in the opinion of the investigator or sponsor poses anunacceptable 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 heartfailure

  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 excisednon metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma insitu; 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) orC 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 participationin another clinical study during the course of this study

  21. Participant is a family member or employee of the investigator or site staff or studyteam

Study Design

Total Participants: 572
Study Start date:
September 01, 2015
Estimated Completion Date:
April 04, 2017

Connect with a study center

  • Medical Centre Asklepii, OOD

    Dupnitsa, 2600
    Bulgaria

    Site Not Available

  • DCC Sveti Georgi EOOD

    Haskovo, 6300
    Bulgaria

    Site Not Available

  • UMHAT Dr.Georgi Stranski, EAD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • DCC Sv. Georgi, EOOD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Department of Dermatology and Venereology, Faculty of Medicine, UMHAT Alexandrovska

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Mediprobe Research Inc

    London, Ontario N5X 2P1
    Canada

    Site Not Available

  • SKDS Research Inc

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • North Bay Dermatology Centre

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • Office of Dr. Michael Robern

    Ottawa, Ontario K2G 6E2
    Canada

    Site Not Available

  • The Centre for Dermatology

    Richmond Hill, Ontario K2G 6E2
    Canada

    Site Not Available

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • K Papp Clinical Research Inc

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Dr. David Gratton Dermatologue Inc.

    Montreal, Quebec H3H 1V4
    Canada

    Site Not Available

  • Recherche GCP Research

    Montréal, Quebec H1M 1B1
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

    Ste-Foy, Quebec G1V 4X7
    Canada

    Site Not Available

  • K Papp Clinical Research Inc

    Ontario, N2J 1C4
    Canada

    Site Not Available

  • Dermatologie - MUDr. HELENA KORANDOVA s.r.o.

    Olomouc-Povel, 100 34
    Czech Republic

    Site Not Available

  • CCBR Czech Prague s.r.o

    Praha 3, Czech Republic 13000
    Czechia

    Site Not Available

  • Dermatologie - MUDr. HELENA KORANDOVA s.r.o.

    Olomouc, Povel 779 00
    Czechia

    Site Not Available

  • CCBR Czech Brno, s.r.o

    Brno, 60200
    Czechia

    Site Not Available

  • CCBR Czech a.s

    Pardubice, 530 02
    Czechia

    Site Not Available

  • Clintrial s.r.o

    Praha 10, 100 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem Dermatovenerologicke oddeleni

    Usti nad Labem, 40113
    Czechia

    Site Not Available

  • MUDr. Jaroslav Dragon - Kozni ordinace

    Ústí nad Labem, 400 10
    Czechia

    Site Not Available

  • Parnu Hospital

    Pärnu, 80010
    Estonia

    Site Not Available

  • East Tallinn Central Hospital

    Tallinn, 11312
    Estonia

    Site Not Available

  • Medicum AS

    Tallinn, 13619
    Estonia

    Site Not Available

  • North Estonia Medical Centre Foundation

    Tallinn, 13419
    Estonia

    Site Not Available

  • Vahlberg & Pild OU

    Tallinn, 10134
    Estonia

    Site Not Available

  • Kliiniliste Uuringute Keskus (Clinical Research Centre)

    Tartu, 50106
    Estonia

    Site Not Available

  • Tartu University Hospital; Dermatology Clinic

    Tartu, 50417
    Estonia

    Site Not Available

  • Universitaetsklinikum Schleswig Holstein

    Schleswig, Holstein 23538
    Germany

    Site Not Available

  • Klinische Forschunq Schwerin GmbH

    Mecklenburg, Vorpommern 19055
    Germany

    Site Not Available

  • Praxis fuer Dermatologie und Venerologie

    Dresden, 01097
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Clinical Research Hamburg

    Hamburg, 22143
    Germany

    Site Not Available

  • Klinische Forschunq Schwerin GmbH

    Mecklenburg Vorpommern, 19055
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig Holstein

    Schleswig Holstein, 23538
    Germany

    Site Not Available

  • Derma Clinic Riga Ltd

    Riga, LV-1003
    Latvia

    Site Not Available

  • Health Centre 4

    Riga, LV-1003
    Latvia

    Site Not Available

  • J. Kisis Ltd

    Riga, LV-1003
    Latvia

    Site Not Available

  • Riga 1 st Hospital

    Riga, 1001
    Latvia

    Site Not Available

  • Ventspils Outpatient Clinic

    Ventspils, LV-3601
    Latvia

    Site Not Available

  • Medica Pro Familia Sp. z o.o. S.K.A.

    Warsaw, Mazowieckie 01-868
    Poland

    Site Not Available

  • Poradnia Kardiologiczna Jaroslaw Jurowiecki

    Gdansk, 80-286
    Poland

    Site Not Available

  • Medica Pro Familia Sp. z o. o. S.K.A. Oddzial w Gdyni

    Gdynia, 81-338
    Poland

    Site Not Available

  • NZOZ POLIMEDICA FILIA KIELCE (Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA)

    Kielce, 25-364
    Poland

    Site Not Available

  • Grazyna Pulka Specjalistyczny Osrodek ALL-MED

    Krakow, 31-023
    Poland

    Site Not Available

  • Medica Pro Familia Sp. z o.o. SK.A.

    Krakow, 30-002
    Poland

    Site Not Available

  • Centrum Medyczne Szpital Swietej Rodziny

    Lodz, 90-302
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej _J.M. Jasnorzewska Sp. Komandytowo-Akcyjna

    Lodz, 90-242
    Poland

    Site Not Available

  • NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

    Lodz, 94-048
    Poland

    Site Not Available

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362
    Poland

    Site Not Available

  • Medicome sp.zoo

    Oswiecim, 32-600
    Poland

    Site Not Available

  • Ai Centrum Medyczne

    Poznan, 61-113
    Poland

    Site Not Available

  • Centrum Badan Klinicznych S.C.

    Poznan, 60-773
    Poland

    Site Not Available

  • KO-MED Centra Kliniczne Pulawy

    Pulawy, 24-100
    Poland

    Site Not Available

  • Centrum Medyczne Medyk

    Rzeszow, 35-055
    Poland

    Site Not Available

  • NZOZ Nasz Lekarz

    Torun, 87-100
    Poland

    Site Not Available

  • MTZ Clinical Research Sp z o.o.

    Warsaw, 02-106
    Poland

    Site Not Available

  • KO-MED Centra Kliniczne Zamosc

    Zamosc, 22-400
    Poland

    Site Not Available

  • Nzoz Polimedica

    Zgierz, 95-100
    Poland

    Site Not Available

  • Pedi-Derma s.r.o.

    Kosice, Kosicky Kraj 04011
    Slovakia

    Site Not Available

  • Derma therapy spol. s.r.o.

    Bratislava, 851 01
    Slovakia

    Site Not Available

  • Nemocnica Kosice-Saca, a.s., 1.sukromna nemocnica

    Kosice, 04015
    Slovakia

    Site Not Available

  • Dema-beauty, s.r.o

    Nitra, 949 01
    Slovakia

    Site Not Available

  • Sanare S.r.o

    Svidnik, 089 01
    Slovakia

    Site Not Available

  • Wallace Medical Group, Inc.

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Encino Research Center

    Encino, California 91436
    United States

    Site Not Available

  • eStudySite

    La Mesa, California 91942
    United States

    Site Not Available

  • eStudySite

    Oceanside, California 92056
    United States

    Site Not Available

  • eStudySite

    San Diego, California 92120
    United States

    Site Not Available

  • Shahram Jacobs MD, INC

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Horizons Clinical Research Center, LLC

    Denver, Colorado 80220
    United States

    Site Not Available

  • Bioclinical Research Alliance; Inc

    Miami, Florida 33155
    United States

    Site Not Available

  • Sanitas Reasearch, LLC

    Miami, Florida 33155
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • Compass Research, LLC

    Orlando, Florida 32806
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Radiant Research; Inc.

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Tufts Medical Center; Inc.

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Bay State Clinical Trials, Inc

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • eStudySite

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Radiant Research; Inc.

    Cincinnati, Ohio 45249
    United States

    Site Not Available

  • Radiant Research, Inc.

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Radiant Clinical Research

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Palmetto Clinical Trial Services, LLC

    Fountain Inn, South Carolina 29644
    United States

    Site Not Available

  • Radiant Research, Inc.

    Greer, South Carolina 29650
    United States

    Site Not Available

  • Austin Institute for Clinical Research, LLC

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Clinical Trials of Texas; Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • National Clinical Research-Richmond, Inc

    Richmond, Virginia 23294
    United States

    Site Not Available

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