NCT02581345CompletedPhase 3
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
Momenta Pharmaceuticals, Inc.174 sites in 6 countries572 target enrollmentStarted: September 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 572
- Locations
- 174
- Primary Endpoint
- Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
M923
Experimental
Participants assigned to receive M923
Intervention: M923 (Biological)
M923 and Humira
Other
Participants assigned to receive M923 and Humira
Intervention: M923 (Biological)
Humira
Active Comparator
Participants assigned to receive Humira
Intervention: Humira (Biological)
M923 and Humira
Other
Participants assigned to receive M923 and Humira
Intervention: Humira (Biological)
Outcomes
Primary Outcomes
Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16
Time Frame: Baseline; 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 Outcomes
- Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16(Week 16)
- Number of Participants Achieving PASI 50 Response at Week 16(Baseline; Week 16)
- Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)(Baseline; Week 52)
- Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)(Baseline; Week 52)
- Number of Participants Achieving PASI 90 Response at Week 16(Baseline; Week 16)
- Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)(Baseline; Week 52)
- Absolute PASI Score at Baseline(Baseline)
- Absolute PASI Score at Week 16(Week 16)
- Absolute PASI Score at Week 52 (Follow-Up Visit)(Week 52)
- Percent Change From Baseline in PASI Score at Week 16(Baseline; Week 16)
- Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)(Baseline; Week 52)
- Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline(Baseline)
- Health-Related Quality of Life During Treatment: DLQI Score at Week 16(Week 16)
- Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)(Week 48)
- Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline(Baseline)
- Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16(Week 16)
- Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)(Week 48)
- Number of Participants With Clinically Meaningful Changes in Vital Signs(Up to Week 52)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline(Baseline)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16(Week 16)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit)(Week 48)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline(Baseline)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16(Week 16)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)(Week 48)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to Week 52)
- Pharmacokinetics: Serum Concentrations by Treatment(Baseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41)
- Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline(Baseline (Week 0))
- Immunogenicity: Number of Participants With ADA at Week 16(Week 16)
- Immunogenicity: Number of Participants With ADA at Week 25(Week 25)
- Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)(Week 52)
- Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline(Baseline (Week 0))
- Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16(Week 16)
- Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25(Week 25)
- Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit)(Week 52)
- Median Time to Seroconversion(Up to Week 52)
Investigators
Study Sites (174)
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