Overview

This trial is active, not recruiting.

Conditions chronic plaque psoriasis, psoriasis
Treatments m923, humira
Phase phase 3
Target TNF-alpha
Sponsor Baxalta US Inc.
Start date September 2015
End date September 2016
Trial size 827 participants
Trial identifier NCT02581345, 911401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants assigned to receive M923
m923 Adalimumab
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
(Active Comparator)
Participants assigned to receive Humira
humira Adalimumab
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
(Other)
Participants assigned to receive M923 and Humira
m923 Adalimumab
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
humira Adalimumab
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

Primary Outcomes

Measure
Psoriasis Area and Severity Index 75% improvement (PASI75) response rate
time frame: Baseline and week 16

Secondary Outcomes

Measure
Proportion of participants with response by static Physician Global Assessment (sPGA) of clear or almost clear
time frame: Baseline and week 16
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
Absolute Psoriasis Area and Severity Index (PASI) score over time
time frame: periodically through 52 weeks
Health-related quality of life during treatment: Dermatology Life Quality Index (DLQI)
time frame: periodically through 48 weeks
Health-related quality of life during treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L)
time frame: periodically through 48 weeks
Clinically significant changes in vital signs
time frame: periodically through 52 weeks
Clinically significant changes in laboratory results
time frame: periodically through 52 weeks
Clinically significant changes in electrocardiograms (ECGs)
time frame: periodically through 48 weeks
Clinically significant adverse events (AEs)
time frame: Throughout the study period of approximately 86 weeks
Clinical safety and tolerability of the shift from Humira to M923
time frame: periodically through 52 weeks
Pharmacokinetics: Trough serum levels
time frame: periodically through 52 weeks
Immunogenicity: proportion of participants experiencing seroconversion, titer of anti-drug antibody (ADA) levels over time, and neutralizing ADA
time frame: periodically through 52 weeks
Immunogenicity: following the shift from Humira to M923
time frame: periodically through 25 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Baxalta US Inc..