Clinical trial NCT02581345: Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis
Official title: A Phase 3 Randomized, Double-blind, Multicenter Study to Evaluate Efficacy, Safety, and Immunogenicity of an Adalimumab Biosimilar (M923) and Humira® in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Psoriasis
Keywords: Moderate to severe chronic plaque psoriasis
Psoriasis
Lead sponsor: Momenta Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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 Criteria:

1. Must be able to understand and communicate with the investigator and comply with the requirements 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 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:

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 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

Primary outcomes:
measure: Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16
timeFrame: Baseline; Week 16
Secondary outcomes:
measure: Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16
timeFrame: Week 16
measure: Number of Participants Achieving PASI 50 Response at Week 16
timeFrame: Baseline; Week 16
measure: Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)
timeFrame: Baseline; Week 52
measure: Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)
timeFrame: Baseline; Week 52
measure: Number of Participants Achieving PASI 90 Response at Week 16
timeFrame: Baseline; Week 16
measure: Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)
timeFrame: Baseline; Week 52
measure: Absolute PASI Score at Baseline
timeFrame: Baseline
measure: Absolute PASI Score at Week 16
timeFrame: Week 16
measure: Absolute PASI Score at Week 52 (Follow-Up Visit)
timeFrame: Week 52
measure: Percent Change From Baseline in PASI Score at Week 16
timeFrame: Baseline; Week 16
measure: Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)
timeFrame: Baseline; Week 52
measure: Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline
timeFrame: Baseline
measure: Health-Related Quality of Life During Treatment: DLQI Score at Week 16
timeFrame: Week 16
measure: Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)
timeFrame: Week 48
measure: Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline
timeFrame: Baseline
measure: Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16
timeFrame: Week 16
measure: Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)
timeFrame: Week 48
measure: Number of Participants With Clinically Meaningful Changes in Vital Signs
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline
timeFrame: Baseline
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16
timeFrame: Week 16
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit)
timeFrame: Week 48
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline
timeFrame: Baseline
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16
timeFrame: Week 16
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)
timeFrame: Week 48
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 52
measure: Pharmacokinetics: Serum Concentrations by Treatment
timeFrame: Baseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41
measure: Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline
timeFrame: Baseline (Week 0)
measure: Immunogenicity: Number of Participants With ADA at Week 16
timeFrame: Week 16
measure: Immunogenicity: Number of Participants With ADA at Week 25
timeFrame: Week 25
measure: Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)
timeFrame: Week 52
measure: Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline
timeFrame: Baseline (Week 0)
measure: Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16
timeFrame: Week 16
measure: Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25
timeFrame: Week 25
measure: Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit)
timeFrame: Week 52
measure: Median Time to Seroconversion
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Wallace Medical Group, Inc.
state: California
city: Encino
country: United States
facility: Encino Research Center
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Oceanside
country: United States
facility: eStudySite
state: California
city: San Diego
country: United States
facility: eStudySite
state: California
city: Sherman Oaks
country: United States
facility: Shahram Jacobs MD, INC
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Miami
country: United States
facility: Bioclinical Research Alliance; Inc
state: Florida
city: Miami
country: United States
facility: Sanitas Reasearch, LLC
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Overland Park
country: United States
facility: Radiant Research; Inc.
state: Kansas
city: Boston
country: United States
facility: Tufts Medical Center; Inc.
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc
state: Massachusetts
city: Las Vegas
country: United States
facility: eStudySite
state: Nevada
city: Cincinnati
country: United States
facility: Radiant Research; Inc.
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Anderson
country: United States
facility: Radiant Clinical Research
state: South Carolina
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas; Inc.
state: Texas
city: Richmond
country: United States
facility: National Clinical Research-Richmond, Inc
state: Virginia
city: Dupnitsa
country: Bulgaria
facility: Medical Centre Asklepii, OOD
city: Haskovo
country: Bulgaria
facility: DCC Sveti Georgi EOOD
city: Pleven
country: Bulgaria
facility: UMHAT Dr.Georgi Stranski, EAD
city: Plovdiv
country: Bulgaria
facility: DCC Sv. Georgi, EOOD
city: Sofia
country: Bulgaria
facility: Department of Dermatology and Venereology, Faculty of Medicine, UMHAT Alexandrovska
city: London
country: Canada
facility: Mediprobe Research Inc
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Ottawa
country: Canada
facility: Office of Dr. Michael Robern
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Waterloo
country: Canada
facility: K Papp Clinical Research Inc
state: Ontario
city: Montreal
country: Canada
facility: Dr. David Gratton Dermatologue Inc.
state: Quebec
city: Montréal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Ste-Foy
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
state: Quebec
city: Praha 3
country: Czechia
facility: CCBR Czech Prague s.r.o
state: Czech Republic
city: Olomouc
country: Czechia
facility: Dermatologie - MUDr. HELENA KORANDOVA s.r.o.
state: Povel
city: Brno
country: Czechia
facility: CCBR Czech Brno, s.r.o
city: Pardubice
country: Czechia
facility: CCBR Czech a.s
city: Praha 10
country: Czechia
facility: Clintrial s.r.o
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem Dermatovenerologicke oddeleni
city: Ústí nad Labem
country: Czechia
facility: MUDr. Jaroslav Dragon - Kozni ordinace
city: Pärnu
country: Estonia
facility: Parnu Hospital
city: Tallinn
country: Estonia
facility: Vahlberg & Pild OU
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tallinn
country: Estonia
facility: Medicum AS
city: Tartu
country: Estonia
facility: Kliiniliste Uuringute Keskus (Clinical Research Centre)
city: Tartu
country: Estonia
facility: Tartu University Hospital; Dermatology Clinic
city: Schleswig
country: Germany
facility: Universitaetsklinikum Schleswig Holstein
state: Holstein
city: Mecklenburg
country: Germany
facility: Klinische Forschunq Schwerin GmbH
state: Vorpommern
city: Dresden
country: Germany
facility: Praxis fuer Dermatologie und Venerologie
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Hamburg
country: Germany
facility: Clinical Research Hamburg
city: Riga
country: Latvia
facility: Riga 1 st Hospital
city: Riga
country: Latvia
facility: Derma Clinic Riga Ltd
city: Riga
country: Latvia
facility: Health Centre 4
city: Riga
country: Latvia
facility: J. Kisis Ltd
city: Riga
country: Latvia
facility: Health Centre 4
city: Ventspils
country: Latvia
facility: Ventspils Outpatient Clinic
city: Warsaw
country: Poland
facility: Medica Pro Familia Sp. z o.o. S.K.A.
state: Mazowieckie
city: Gdansk
country: Poland
facility: Poradnia Kardiologiczna Jaroslaw Jurowiecki
city: Gdynia
country: Poland
facility: Medica Pro Familia Sp. z o. o. S.K.A. Oddzial w Gdyni
city: Kielce
country: Poland
facility: NZOZ POLIMEDICA FILIA KIELCE (Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA)
city: Krakow
country: Poland
facility: Medica Pro Familia Sp. z o.o. SK.A.
city: Krakow
country: Poland
facility: Grazyna Pulka Specjalistyczny Osrodek ALL-MED
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej _J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
city: Lodz
country: Poland
facility: Centrum Medyczne Szpital Swietej Rodziny
city: Lodz
country: Poland
facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Oswiecim
country: Poland
facility: Medicome sp.zoo
city: Poznan
country: Poland
facility: Centrum Badan Klinicznych S.C.
city: Poznan
country: Poland
facility: Ai Centrum Medyczne
city: Pulawy
country: Poland
facility: KO-MED Centra Kliniczne Pulawy
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz
city: Warsaw
country: Poland
facility: MTZ Clinical Research Sp z o.o.
city: Zamosc
country: Poland
facility: KO-MED Centra Kliniczne Zamosc
city: Zgierz
country: Poland
facility: Nzoz Polimedica
city: Kosice
country: Slovakia
facility: Pedi-Derma s.r.o.
state: Kosicky Kraj
city: Bratislava
country: Slovakia
facility: Derma therapy spol. s.r.o.
city: Kosice
country: Slovakia
facility: Nemocnica Kosice-Saca, a.s., 1.sukromna nemocnica
city: Nitra
country: Slovakia
facility: Dema-beauty, s.r.o
city: Svidnik
country: Slovakia
facility: Sanare S.r.o
Study officials:
affiliation: Shire
name: John Caminis, MD
role: STUDY_DIRECTOR
References: