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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Chronic Plaque Psoriasis
• Intervention / Treatment: Biological: M923; Biological: Humira

• Study Type: Interventional
• Enrollment (Actual): 572
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Medical Centre Asklepii, OOD
  • Haskovo, Bulgaria, 6300
    • DCC Sveti Georgi EOOD
  • Pleven, Bulgaria, 5800
    • UMHAT Dr.Georgi Stranski, EAD
  • Plovdiv, Bulgaria, 4000
    • DCC Sv. Georgi, EOOD
  • Sofia, Bulgaria, 1431
    • Department of Dermatology and Venereology, Faculty of Medicine, UMHAT Alexandrovska
• Canada
  • Ontario
    • London, Ontario, Canada, N5X 2P1
      • Mediprobe Research Inc
    • Newmarket, Ontario, Canada, L3Y 5G8
      • SKDS Research Inc
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
    • Ottawa, Ontario, Canada, K2G 6E2
      • Office of Dr. Michael Robern
    • Richmond Hill, Ontario, Canada, K2G 6E2
      • The Centre for Dermatology
    • Sarnia, Ontario, Canada, N7T 4X3
      • London Road Diagnostic Clinic and Medical Centre
    • Waterloo, Ontario, Canada, N2J 1C4
      • K Papp Clinical Research Inc
  • Quebec
    • Montreal, Quebec, Canada, H3H 1V4
      • Dr. David Gratton Dermatologue Inc.
    • Montréal, Quebec, Canada, H1M 1B1
      • Recherche GCP Research
    • Ste-Foy, Quebec, Canada, G1V 4X7
      • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
• Czechia
  • Brno, Czechia, 60200
    • CCBR Czech Brno, s.r.o
  • Pardubice, Czechia, 530 02
    • CCBR Czech a.s
  • Praha 10, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 10, Czechia, 100 00
    • Clintrial S.R.O
  • Usti nad Labem, Czechia, 40113
    • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem Dermatovenerologicke oddeleni
  • Ústí nad Labem, Czechia, 400 10
    • MUDr. Jaroslav Dragon - Kozni ordinace
  • Czech Republic
    • Praha 3, Czech Republic, Czechia, 13000
      • CCBR Czech Prague s.r.o
  • Povel
    • Olomouc, Povel, Czechia, 779 00
      • Dermatologie - MUDr. HELENA KORANDOVA s.r.o.
• Estonia
  • Pärnu, Estonia, 80010
    • Parnu Hospital
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
  • Tallinn, Estonia, 11312
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 10134
    • Vahlberg & Pild OU
  • Tallinn, Estonia, 13619
    • Medicum AS
  • Tartu, Estonia, 50106
    • Kliiniliste Uuringute Keskus (Clinical Research Centre)
  • Tartu, Estonia, 50417
    • Tartu University Hospital; Dermatology Clinic
• Germany
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus Tu Dresden
  • Dresden, Germany, 01097
    • Praxis fuer Dermatologie und Venerologie
  • Frankfurt am Main, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Hamburg, Germany, 22143
    • Clinical Research Hamburg
  • Holstein
    • Schleswig, Holstein, Germany, 23538
      • Universitaetsklinikum Schleswig Holstein
  • Vorpommern
    • Mecklenburg, Vorpommern, Germany, 19055
      • Klinische Forschunq Schwerin GmbH
• Latvia
  • Riga, Latvia, 1001
    • Riga 1 st Hospital
  • Riga, Latvia, LV-1003
    • Derma Clinic Riga Ltd
  • Riga, Latvia, LV-1003
    • Health Centre 4
  • Riga, Latvia, LV-1003
    • J. Kisis Ltd
  • Riga, Latvia, LV-1013
    • Health Centre 4
  • Ventspils, Latvia, LV-3601
    • Ventspils Outpatient Clinic
• Poland
  • Gdansk, Poland, 80-286
    • Poradnia Kardiologiczna Jaroslaw Jurowiecki
  • Gdynia, Poland, 81-338
    • Medica Pro Familia Sp. z o. o. S.K.A. Oddzial w Gdyni
  • Kielce, Poland, 25-364
    • NZOZ POLIMEDICA FILIA KIELCE (Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA)
  • Krakow, Poland, 31-023
    • Grazyna Pulka Specjalistyczny Osrodek All-med
  • Krakow, Poland, 30-002
    • Medica Pro Familia Sp. z o.o. SK.A.
  • Lodz, Poland, 94-048
    • NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
  • Lodz, Poland, 90-302
    • Centrum Medyczne Szpital Świętej Rodziny
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej _J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
  • Lublin, Poland, 20-362
    • KO-MED Centra Kliniczne Lublin II
  • Oswiecim, Poland, 32-600
    • Medicome sp.zoo
  • Poznan, Poland, 61-113
    • AI Centrum Medyczne
  • Poznan, Poland, 60-773
    • Centrum Badan Klinicznych S.C.
  • Pulawy, Poland, 24-100
    • KO-MED Centra Kliniczne Pulawy
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne Medyk
  • Torun, Poland, 87-100
    • NZOZ Nasz Lekarz
  • Warsaw, Poland, 02-106
    • MTZ Clinical Research Sp z o.o.
  • Zamosc, Poland, 22-400
    • KO-MED Centra Kliniczne Zamosc
  • Zgierz, Poland, 95-100
    • NZOZ Polimedica
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 01-868
      • Medica Pro Familia sp. z o.o. S.K.A.
• Slovakia
  • Bratislava, Slovakia, 851 01
    • Derma therapy spol. s.r.o.
  • Kosice, Slovakia, 04015
    • Nemocnica Kosice-Saca, a.s., 1.sukromna nemocnica
  • Nitra, Slovakia, 949 01
    • Dema-beauty, s.r.o
  • Svidnik, Slovakia, 089 01
    • SANARE s.r.o
  • Kosicky Kraj
    • Kosice, Kosicky Kraj, Slovakia, 04011
      • Pedi-Derma s.r.o.
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group, Inc.
    • Encino, California, United States, 91436
      • Encino Research Center
    • La Mesa, California, United States, 91942
      • eStudySite
    • Oceanside, California, United States, 92056
      • eStudySite
    • San Diego, California, United States, 92120
      • eStudySite
    • Sherman Oaks, California, United States, 91403
      • Shahram Jacobs MD, INC
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
  • Florida
    • Miami, Florida, United States, 33155
      • Bioclinical Research Alliance; Inc
    • Miami, Florida, United States, 33155
      • Sanitas Reasearch, LLC
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Radiant Research; Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center; Inc.
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • eStudySite
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research; Inc.
    • Columbus, Ohio, United States, 43212
      • Radiant Research, Inc.
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Clinical Research
    • Fountain Inn, South Carolina, United States, 29644
      • Palmetto Clinical Trial Services, LLC
    • Greer, South Carolina, United States, 29650
      • Radiant Research, Inc.
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, LLC
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas; Inc.
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research-Richmond, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: M923; Participants assigned to receive M923	Biological: M923; Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α); Other Names: Adalimumab
ACTIVE_COMPARATOR: Humira; Participants assigned to receive Humira	Biological: Humira; Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α); Other Names: Adalimumab
OTHER: M923 and Humira; Participants assigned to receive M923 and Humira	Biological: M923; Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α); Other Names: Adalimumab; Biological: Humira; Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α); Other Names: Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% in the Week 16 PASI score compared to the score at Baseline.	Baseline; Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16	The sPGA response rate was defined as the percentage of participants who had achieved a clear or almost clear response on the 6-point sPGA scale. The sPGA was the physician's determination of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on a 6-point scale on which 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe.	Week 16
Number of Participants Achieving PASI 50 Response at Week 16	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.	Baseline; Week 16
Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.	Baseline; Week 52
Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% compared to Baseline.	Baseline; Week 52
Number of Participants Achieving PASI 90 Response at Week 16	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.	Baseline; Week 16
Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.	Baseline; Week 52
Absolute PASI Score at Baseline	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.	Baseline
Absolute PASI Score at Week 16	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.	Week 16
Absolute PASI Score at Week 52 (Follow-Up Visit)	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.	Week 52
Percent Change From Baseline in PASI Score at Week 16	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value - Baseline value) / (Baseline value) * 100.	Baseline; Week 16
Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)	The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value - Baseline value) / (Baseline value) * 100.	Baseline; Week 52
Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline	The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.	Baseline
Health-Related Quality of Life During Treatment: DLQI Score at Week 16	The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.	Week 16
Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)	The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.	Week 48
Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline	The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine". Baseline was defined as the last scheduled observation prior to dosing, typically Day 1, predose.	Baseline
Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16	The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine".	Week 16
Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)	The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine".	Week 48
Number of Participants With Clinically Meaningful Changes in Vital Signs	Vital signs included body temperature, respiratory rate, pulse rate, systolic and diastolic blood pressure, and weight. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.	Up to Week 52
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline	Laboratory results included hematology [Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis [Specific Gravity] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.	Baseline
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16	Laboratory results included hematology [Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis [Specific Gravity] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.	Week 16
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit)	Laboratory results included hematology [Red Blood Cell Count, Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes absolute, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Alkaline Phosphatase, Gamma glutamyl transferase, Total bilirubin, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Sodium, Potassium, Chloride, Urea, Creatinine, Albumin, Phosphate, Glucose, and Uric acid) and urinalysis [pH and Specific Gravity] parameters. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.	Week 48
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline	Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.	Baseline
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16	Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.	Week 16
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)	Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.	Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	TEAEs are adverse events that occurred during or after study drug administration. For more details on adverse events please refer the safety section.	Up to Week 52
Pharmacokinetics: Serum Concentrations by Treatment	Serum samples were collected at Baseline (Week 0, perdose), approximately 1 week (peak) after IP administration (Weeks 8 and 16), and 2 weeks after dose administration as a trough sample collected prior to the next dose administration (Weeks 17, 21, 25, 29, 37, 41).	Baseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41
Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline	The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.	Baseline (Week 0)
Immunogenicity: Number of Participants With ADA at Week 16	The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.	Week 16
Immunogenicity: Number of Participants With ADA at Week 25	The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.	Week 25
Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)	The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.	Week 52
Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline	The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.	Baseline (Week 0)
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16	The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.	Week 16
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25	The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.	Week 25
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit)	The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.	Week 52
Median Time to Seroconversion	Time to seroconversion (in days) was defined as the time to the observation of the first confirmed positive ADA response. Participants with confirmed positive ADA response at baseline (Week 0 predose) were excluded.	Up to Week 52

Collaborators and Investigators

• Sponsor: Momenta Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): April 4, 2017
• Study Completion (ACTUAL): April 4, 2017

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (ESTIMATE): October 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Psoriasis; Moderate to severe chronic plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: 911401