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

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ClinicalTrials.gov Identifier: NCT02581345
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Psoriasis Biological: M923 Biological: Humira Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 827 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2015
Primary Completion Date : September 2016
Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Adalimumab
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 Name: Adalimumab
Biological: Humira
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Other Name: Adalimumab


Outcome Measures

Primary Outcome Measures :
  1. Psoriasis Area and Severity Index 75% improvement (PASI75) response rate [ Time Frame: Baseline and week 16 ]

Secondary Outcome Measures :
  1. Proportion of participants with response by static Physician Global Assessment (sPGA) of clear or almost clear [ Time Frame: Baseline and week 16 ]
  2. Psoriasis Area and Severity Index (PASI)50, PASI75, PASI90, and static Physician Global Assessment (sPGA) response rates over time [ Time Frame: periodically through 52 weeks ]
  3. Absolute Psoriasis Area and Severity Index (PASI) score over time [ Time Frame: periodically through 52 weeks ]
  4. Health-related quality of life during treatment: Dermatology Life Quality Index (DLQI) [ Time Frame: periodically through 48 weeks ]
  5. Health-related quality of life during treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) [ Time Frame: periodically through 48 weeks ]
  6. Clinically significant changes in vital signs [ Time Frame: periodically through 52 weeks ]
  7. Clinically significant changes in laboratory results [ Time Frame: periodically through 52 weeks ]
  8. Clinically significant changes in electrocardiograms (ECGs) [ Time Frame: periodically through 48 weeks ]
  9. Clinically significant adverse events (AEs) [ Time Frame: Throughout the study period of approximately 86 weeks ]
  10. Clinical safety and tolerability of the shift from Humira to M923 [ Time Frame: periodically through 52 weeks ]
  11. Pharmacokinetics: Trough serum levels [ Time Frame: periodically through 52 weeks ]
  12. Immunogenicity: proportion of participants experiencing seroconversion, titer of anti-drug antibody (ADA) levels over time, and neutralizing ADA [ Time Frame: periodically through 52 weeks ]
  13. Immunogenicity: following the shift from Humira to M923 [ Time Frame: periodically through 25 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581345


  Show 90 Study Locations
Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
Investigators
Study Director: John Caminis, MD Shire
More Information

Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02581345     History of Changes
Other Study ID Numbers: 911401
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: April 2017

Keywords provided by Momenta Pharmaceuticals, Inc.:
Moderate to severe chronic plaque psoriasis
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Immunoglobulin G
Anti-Inflammatory Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs