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

Primary Purpose

Chronic Plaque Psoriasis, Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

M923

Humira

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Moderate to severe chronic plaque psoriasis, Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must be able to understand and communicate with the investigator and comply with the requirements of the study
Chronic plaque-type psoriasis diagnosed for at least 6 months before screening
Stable plaque psoriasis
History of receipt of or candidate for therapy.
Moderate to severe psoriasis at screening and baseline
Must be willing and able to self-administer SC injections or have a caregiver available to administer injections
Male participants of childbearing potential must employ a highly effective contraceptive measure
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:

Forms of psoriasis other than chronic plaque-type
Drug-induced psoriasis.
Other skin conditions which would interfere with assessment of psoriasis
Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening
Other inflammatory conditions other than psoriasis or psoriatic arthritis
Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies
Ongoing use of prohibited psoriasis treatments
Ongoing use of other non-psoriasis prohibited treatments
All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks
Laboratory abnormalities at screening deemed clinically significant by the investigator
Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk
History of latex allergy
History of or current signs or symptoms or diagnosis of a demyelinating disorder
History of or current Class III or IV New York Heart Association congestive heart failure
Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
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
Chronic infections, recurrent infections; recent infection to be evaluated
History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or C virus (HCV)
History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
Exposure to an investigational product ≤30 days prior to enrollment or participation in another clinical study during the course of this study
Participant is a family member or employee of the investigator or site staff or study team

Sites / Locations

Wallace Medical Group, Inc.
Encino Research Center
eStudySite
eStudySite
eStudySite
Shahram Jacobs MD, INC
Horizons Clinical Research Center, LLC
Bioclinical Research Alliance; Inc
Sanitas Reasearch, LLC
Renstar Medical Research
Compass Research, LLC
Dawes Fretzin Clinical Research Group, LLC
Radiant Research; Inc.
Tufts Medical Center; Inc.
Bay State Clinical Trials, Inc
eStudySite
Radiant Research; Inc.
Radiant Research, Inc.
Radiant Clinical Research
Palmetto Clinical Trial Services, LLC
Radiant Research, Inc.
Austin Institute for Clinical Research, LLC
Clinical Trials of Texas; Inc.
National Clinical Research-Richmond, Inc
Medical Centre Asklepii, OOD
DCC Sveti Georgi EOOD
UMHAT Dr.Georgi Stranski, EAD
DCC Sv. Georgi, EOOD
Department of Dermatology and Venereology, Faculty of Medicine, UMHAT Alexandrovska
Mediprobe Research Inc
SKDS Research Inc
North Bay Dermatology Centre
Office of Dr. Michael Robern
The Centre for Dermatology
London Road Diagnostic Clinic and Medical Centre
K Papp Clinical Research Inc
Dr. David Gratton Dermatologue Inc.
Recherche GCP Research
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
CCBR Czech Prague s.r.o
Dermatologie - MUDr. HELENA KORANDOVA s.r.o.
CCBR Czech Brno, s.r.o
CCBR Czech a.s
Clintrial s.r.o
Fakultni nemocnice Kralovske Vinohrady
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem Dermatovenerologicke oddeleni
MUDr. Jaroslav Dragon - Kozni ordinace
Parnu Hospital
Vahlberg & Pild OU
East Tallinn Central Hospital
North Estonia Medical Centre Foundation
Medicum AS
Kliiniliste Uuringute Keskus (Clinical Research Centre)
Tartu University Hospital; Dermatology Clinic
Universitaetsklinikum Schleswig Holstein
Klinische Forschunq Schwerin GmbH
Praxis fuer Dermatologie und Venerologie
Universitaetsklinikum Carl Gustav Carus TU Dresden
Klinikum der Johann Wolfgang Goethe-Universitaet
Clinical Research Hamburg
Riga 1 st Hospital
Derma Clinic Riga Ltd
Health Centre 4
J. Kisis Ltd
Health Centre 4
Ventspils Outpatient Clinic
Medica Pro Familia Sp. z o.o. S.K.A.
Poradnia Kardiologiczna Jaroslaw Jurowiecki
Medica Pro Familia Sp. z o. o. S.K.A. Oddzial w Gdyni
NZOZ POLIMEDICA FILIA KIELCE (Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA)
Medica Pro Familia Sp. z o.o. SK.A.
Grazyna Pulka Specjalistyczny Osrodek ALL-MED
Centrum Terapii Wspolczesnej _J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
Centrum Medyczne Szpital Swietej Rodziny
NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
KO-MED Centra Kliniczne Lublin II
Medicome sp.zoo
Centrum Badan Klinicznych S.C.
Ai Centrum Medyczne
KO-MED Centra Kliniczne Pulawy
Centrum Medyczne Medyk
NZOZ Nasz Lekarz
MTZ Clinical Research Sp z o.o.
KO-MED Centra Kliniczne Zamosc
Nzoz Polimedica
Pedi-Derma s.r.o.
Derma therapy spol. s.r.o.
Nemocnica Kosice-Saca, a.s., 1.sukromna nemocnica
Dema-beauty, s.r.o
Sanare S.r.o

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

M923

Humira

M923 and Humira

Arm Description

Participants assigned to receive M923

Participants assigned to receive Humira

Participants assigned to receive M923 and Humira

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)

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.

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.

Absolute PASI Score at Baseline

Absolute PASI Score at Week 16

Absolute PASI Score at Week 52 (Follow-Up Visit)

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.

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.

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.

Health-Related Quality of Life During Treatment: DLQI Score at Week 16

Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)

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.

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".

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".

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.

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.

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at 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.

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.

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.

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.

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.

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).

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.

Immunogenicity: Number of Participants With ADA at Week 16

Immunogenicity: Number of Participants With ADA at Week 25

Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02581345

First Posted

October 19, 2015

Last Updated

October 15, 2018

Sponsor

Momenta Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02581345

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

April 4, 2017 (Actual)

Study Completion Date

April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Momenta Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Plaque Psoriasis, Psoriasis

Keywords

Moderate to severe chronic plaque psoriasis, Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

572 (Actual)

8. Arms, Groups, and Interventions

Arm Title

M923

Arm Type

Experimental

Arm Description

Participants assigned to receive M923

Arm Title

Humira

Arm Type

Active Comparator

Arm Description

Participants assigned to receive Humira

Arm Title

M923 and Humira

Arm Type

Other

Arm Description

Participants assigned to receive M923 and Humira

Intervention Type

Biological

Intervention Name(s)

M923

Other Intervention Name(s)

Adalimumab

Intervention Description

Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

Intervention Type

Biological

Intervention Name(s)

Humira

Other Intervention Name(s)

Adalimumab

Intervention Description

Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16

Description

Time Frame

Baseline; Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16

Description

Time Frame

Week 16

Title

Number of Participants Achieving PASI 50 Response at Week 16

Description

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.

Time Frame

Baseline; Week 16

Title

Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)

Description

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.

Time Frame

Baseline; Week 52

Title

Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)

Description

Time Frame

Baseline; Week 52

Title

Number of Participants Achieving PASI 90 Response at Week 16

Description

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.

Time Frame

Baseline; Week 16

Title

Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)

Description

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.

Time Frame

Baseline; Week 52

Title

Absolute PASI Score at Baseline

Description

Time Frame

Baseline

Title

Absolute PASI Score at Week 16

Description

Time Frame

Week 16

Title

Absolute PASI Score at Week 52 (Follow-Up Visit)

Description

Time Frame

Week 52

Title

Percent Change From Baseline in PASI Score at Week 16

Description

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.

Time Frame

Baseline; Week 16

Title

Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)

Description

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.

Time Frame

Baseline; Week 52

Title

Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline

Description

Time Frame

Baseline

Title

Health-Related Quality of Life During Treatment: DLQI Score at Week 16

Description

Time Frame

Week 16

Title

Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)

Description

Time Frame

Week 48

Title

Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline

Description

Time Frame

Baseline

Title

Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16

Description

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".

Time Frame

Week 16

Title

Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)

Description

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".

Time Frame

Week 48

Title

Number of Participants With Clinically Meaningful Changes in Vital Signs

Description

Time Frame

Up to Week 52

Title

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline

Description

Time Frame

Baseline

Title

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16

Description

Time Frame

Week 16

Title

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit)

Description

Time Frame

Week 48

Title

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline

Description

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Time Frame

Baseline

Title

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16

Description

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Time Frame

Week 16

Title

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)

Description

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Time Frame

Week 48

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

TEAEs are adverse events that occurred during or after study drug administration. For more details on adverse events please refer the safety section.

Time Frame

Up to Week 52

Title

Pharmacokinetics: Serum Concentrations by Treatment

Description

Time Frame

Baseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41

Title

Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline

Description

Time Frame

Baseline (Week 0)

Title

Immunogenicity: Number of Participants With ADA at Week 16

Description

Time Frame

Week 16

Title

Immunogenicity: Number of Participants With ADA at Week 25

Description

Time Frame

Week 25

Title

Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)

Description

Time Frame

Week 52

Title

Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline

Description

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.

Time Frame

Baseline (Week 0)

Title

Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16

Description

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.

Time Frame

Week 16

Title

Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25

Description

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.

Time Frame

Week 25

Title

Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit)

Description

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.

Time Frame

Week 52

Title

Median Time to Seroconversion

Description

Time Frame

Up to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be able to understand and communicate with the investigator and comply with the requirements of the study Chronic plaque-type psoriasis diagnosed for at least 6 months before screening Stable plaque psoriasis History of receipt of or candidate for therapy. Moderate to severe psoriasis at screening and baseline Must be willing and able to self-administer SC injections or have a caregiver available to administer injections Male participants of childbearing potential must employ a highly effective contraceptive measure 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: Forms of psoriasis other than chronic plaque-type Drug-induced psoriasis. Other skin conditions which would interfere with assessment of psoriasis Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening Other inflammatory conditions other than psoriasis or psoriatic arthritis Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies Ongoing use of prohibited psoriasis treatments Ongoing use of other non-psoriasis prohibited treatments All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks Laboratory abnormalities at screening deemed clinically significant by the investigator Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk History of latex allergy History of or current signs or symptoms or diagnosis of a demyelinating disorder History of or current Class III or IV New York Heart Association congestive heart failure Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma 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 Chronic infections, recurrent infections; recent infection to be evaluated History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or C virus (HCV) History of active tuberculosis (TB) or untreated or inadequately treated latent TB. Exposure to an investigational product ≤30 days prior to enrollment or participation in another clinical study during the course of this study Participant is a family member or employee of the investigator or site staff or study team

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Caminis, MD

Organizational Affiliation

Shire

Official's Role

Study Director

Facility Information:

Facility Name

Wallace Medical Group, Inc.

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Encino Research Center

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

eStudySite

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

eStudySite

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

eStudySite

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Shahram Jacobs MD, INC

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

Horizons Clinical Research Center, LLC

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Bioclinical Research Alliance; Inc

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Sanitas Reasearch, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Compass Research, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Radiant Research; Inc.

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Tufts Medical Center; Inc.

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Bay State Clinical Trials, Inc

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

eStudySite

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Radiant Research; Inc.

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

Radiant Research, Inc.

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

Radiant Clinical Research

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Palmetto Clinical Trial Services, LLC

City

Fountain Inn

State/Province

South Carolina

ZIP/Postal Code

29644

Country

United States

Facility Name

Radiant Research, Inc.

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Austin Institute for Clinical Research, LLC

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Clinical Trials of Texas; Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

National Clinical Research-Richmond, Inc

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Medical Centre Asklepii, OOD

City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Facility Name

DCC Sveti Georgi EOOD

City

Haskovo

ZIP/Postal Code

6300

Country

Bulgaria

Facility Name

UMHAT Dr.Georgi Stranski, EAD

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

DCC Sv. Georgi, EOOD

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

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

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Mediprobe Research Inc

City

London

State/Province

Ontario

ZIP/Postal Code

N5X 2P1

Country

Canada

Facility Name

SKDS Research Inc

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

North Bay Dermatology Centre

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 3Z7

Country

Canada

Facility Name

Office of Dr. Michael Robern

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2G 6E2

Country

Canada

Facility Name

The Centre for Dermatology

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

K2G 6E2

Country

Canada

Facility Name

London Road Diagnostic Clinic and Medical Centre

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

K Papp Clinical Research Inc

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Dr. David Gratton Dermatologue Inc.

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3H 1V4

Country

Canada

Facility Name

Recherche GCP Research

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1M 1B1

Country

Canada

Facility Name

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

Facility Name

CCBR Czech Prague s.r.o

City

Praha 3

State/Province

Czech Republic

ZIP/Postal Code

13000

Country

Czechia

Facility Name

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

City

Olomouc

State/Province

Povel

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

CCBR Czech Brno, s.r.o

City

Brno

ZIP/Postal Code

60200

Country

Czechia

Facility Name

CCBR Czech a.s

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Clintrial s.r.o

City

Praha 10

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Fakultni nemocnice Kralovske Vinohrady

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

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

City

Usti nad Labem

ZIP/Postal Code

40113

Country

Czechia

Facility Name

MUDr. Jaroslav Dragon - Kozni ordinace

City

Ústí nad Labem

ZIP/Postal Code

400 10

Country

Czechia

Facility Name

Parnu Hospital

City

Pärnu

ZIP/Postal Code

80010

Country

Estonia

Facility Name

Vahlberg & Pild OU

City

Tallinn

ZIP/Postal Code

10134

Country

Estonia

Facility Name

East Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

11312

Country

Estonia

Facility Name

North Estonia Medical Centre Foundation

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Medicum AS

City

Tallinn

ZIP/Postal Code

13619

Country

Estonia

Facility Name

Kliiniliste Uuringute Keskus (Clinical Research Centre)

City

Tartu

ZIP/Postal Code

50106

Country

Estonia

Facility Name

Tartu University Hospital; Dermatology Clinic

City

Tartu

ZIP/Postal Code

50417

Country

Estonia

Facility Name

Universitaetsklinikum Schleswig Holstein

City

Schleswig

State/Province

Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

Klinische Forschunq Schwerin GmbH

City

Mecklenburg

State/Province

Vorpommern

ZIP/Postal Code

19055

Country

Germany

Facility Name

Praxis fuer Dermatologie und Venerologie

City

Dresden

ZIP/Postal Code

01097

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus TU Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Klinikum der Johann Wolfgang Goethe-Universitaet

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Clinical Research Hamburg

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

Riga 1 st Hospital

City

Riga

ZIP/Postal Code

1001

Country

Latvia

Facility Name

Derma Clinic Riga Ltd

City

Riga

ZIP/Postal Code

LV-1003

Country

Latvia

Facility Name

Health Centre 4

City

Riga

ZIP/Postal Code

LV-1003

Country

Latvia

Facility Name

J. Kisis Ltd

City

Riga

ZIP/Postal Code

LV-1003

Country

Latvia

Facility Name

Health Centre 4

City

Riga

ZIP/Postal Code

LV-1013

Country

Latvia

Facility Name

Ventspils Outpatient Clinic

City

Ventspils

ZIP/Postal Code

LV-3601

Country

Latvia

Facility Name

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

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

01-868

Country

Poland

Facility Name

Poradnia Kardiologiczna Jaroslaw Jurowiecki

City

Gdansk

ZIP/Postal Code

80-286

Country

Poland

Facility Name

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

City

Gdynia

ZIP/Postal Code

81-338

Country

Poland

Facility Name

NZOZ POLIMEDICA FILIA KIELCE (Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA)

City

Kielce

ZIP/Postal Code

25-364

Country

Poland

Facility Name

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

City

Krakow

ZIP/Postal Code

30-002

Country

Poland

Facility Name

Grazyna Pulka Specjalistyczny Osrodek ALL-MED

City

Krakow

ZIP/Postal Code

31-023

Country

Poland

Facility Name

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

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

Centrum Medyczne Szpital Swietej Rodziny

City

Lodz

ZIP/Postal Code

90-302

Country

Poland

Facility Name

NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

City

Lodz

ZIP/Postal Code

94-048

Country

Poland

Facility Name

KO-MED Centra Kliniczne Lublin II

City

Lublin

ZIP/Postal Code

20-362

Country

Poland

Facility Name

Medicome sp.zoo

City

Oswiecim

ZIP/Postal Code

32-600

Country

Poland

Facility Name

Centrum Badan Klinicznych S.C.

City

Poznan

ZIP/Postal Code

60-773

Country

Poland

Facility Name

Ai Centrum Medyczne

City

Poznan

ZIP/Postal Code

61-113

Country

Poland

Facility Name

KO-MED Centra Kliniczne Pulawy

City

Pulawy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

Centrum Medyczne Medyk

City

Rzeszow

ZIP/Postal Code

35-055

Country

Poland

Facility Name

NZOZ Nasz Lekarz

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

MTZ Clinical Research Sp z o.o.

City

Warsaw

ZIP/Postal Code

02-106

Country

Poland

Facility Name

KO-MED Centra Kliniczne Zamosc

City

Zamosc

ZIP/Postal Code

22-400

Country

Poland

Facility Name

Nzoz Polimedica

City

Zgierz

ZIP/Postal Code

95-100

Country

Poland

Facility Name

Pedi-Derma s.r.o.

City

Kosice

State/Province

Kosicky Kraj

ZIP/Postal Code

04011

Country

Slovakia

Facility Name

Derma therapy spol. s.r.o.

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

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

City

Kosice

ZIP/Postal Code

04015

Country

Slovakia

Facility Name

Dema-beauty, s.r.o

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Sanare S.r.o

City

Svidnik

ZIP/Postal Code

089 01

Country

Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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