Chronic plaque-type psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: M923
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: M923
Other descriptive name: M923 40m
Sponsors
Momenta Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be = 18 years old at the time of screening 2. Must be able to understand and communicate with the investigator and comply with the requirements of the study (including administration of SC injections at home) and must give a written, signed, and dated informed consent before any study-related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations 3. Chronic plaque-type psoriasis diagnosed for at least 6 months before screening 4. Stable plaque-type psoriasis, defined as no significant change in lesional area or severity, for a period of 2 months or more before screening 5. History of receipt of or candidate for systemic therapy or phototherapy with active plaque-like psoriasis despite topical therapy 6. Moderate to severe psoriasis at screening and baseline (Visit 2), defined as: a. PASI score = 12 b. sPGA score = 3 (based on a scale of 0 - 5) c. Body Surface Area (BSA) affected by plaque-type psoriasis = 10% 7. Must be willing and able to self-administer SC injections or have a caregiver available to administer injections 8. Male subjects must either abstain from sexual intercourse or use a condom in addition to having their female partner use another form of contraception such as an intra-uterine device, barrier method (eg, diaphragm or sponge; female condom not permitted) with spermicide, oral contraceptive, injectable progesterone, sub-dermal implant, unless their partners are infertile or surgically sterile from the time of the first administration of IP until completion of study procedures. Alternatively, male subjects may have been vasectomized, with confirmation of sterility. 9. Female subjects must have a negative pregnancy test at screening and baseline and must not be lactating. Female subjects must also meet one of the conditions below for the entire duration of the study: a. Abstain from sexual intercourse b. Use a method of contraception, as described for female partners in Inclusion Criterion 8, and have their male partner use a condom until 5 months after the last administration of the IP c. Be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria: i. Postmenopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone levels drawn during screening within the laboratory-defined postmenopausal range or postmenopausal with amenorrhea for at least 24 months and on hormonal replacement therapy. ii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, bilateral tubal ligation (BTL; with no subsequent pregnancy at least 1 year from BTL), or bilateral salpingectomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 516 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic, or guttate psoriasis) 2. History of or current drug-induced psoriasis (eg, from beta-blockers or lithium). 3. Presence of other skin conditions, including skin infections, which would interfere with assessment of psoriasis 4. Presence of chronic or ongoing medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening, eg, asthma 5. Presence of other inflammatory conditions other than psoriasis or psoriatic arthritis, eg, rheumatoid arthritis, gout, inflammatory bowel disease 6. Subject must have no major deviations regarding concomitant medication, such as prior use of systemic tumor necrosis factor (TNF) inhibitor therapy, investigational or licensed (ie, other investigational biosimilar TNF inhibitor therapy exposure is not permitted), or 2 or more non-TNF biologic therapies required concomitantly 7. Ongoing use of prohibited psoriasis treatments (eg, prohibited topical corticosteroids, systemic corticosteroids, ultraviolet (UV) therapy including excessive sun exposure, immunosuppressant therapy, including MTX); washout periods detailed in Section 10.4 must be followed 8. Ongoing use of other non-psoriasis prohibited treatments; washout periods detailed in Section 10.4 must be followed. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks before baseline (Visit 2) 9. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks before baseline 10. Laboratory abnormalities at screening deemed clinically significant by the investigator and/or: a. Hemoglobin 1.5 times the upper limit of normal e. Creatinine > 1.5 mg/dL if upper limit of normal if = 65 years old 11. Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease, including pleural effusions or ascites, which in the opinion of the investigator or sponsor pose 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. History or current 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 (3 or more of the same infection requiring anti-infective treatment in any rolling 12 month period); any recent infection requiring hospitalization or any infection requiring parenteral anti-infective therapy within 30 days or oral infective therapies within 14 days of baseline (Visit 2); herpes zoster within 6 months of baseline or more than 2 lifetime episodes of herpes zoster; or history of systemic fungal infection or opportunistic infection (eg, coccidiomycosis, histoplasmosis, toxoplasmosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate equivalence in measures of efficacy between M923 (test) and EU-licensed Humira (referred to as the Reference Protein Product (EU RPP) in subjects with moderate to severe chronic plaque-type psoriasis.;Secondary Objective: 1. Evaluate the continued efficacy safety, immunogenicity, and tolerability of M923 compared with EU RPP 2. Evaluate the transition from EU RPP to M923 based on safety and immunogenicity compared with continuous use of EU RPP 3. Evaluate concentrations over time;Primary end point(s): The primary outcome measure is the Psoriasis Area and Severity Index 75% improvement (PASI75) response rate at Week 13 in subjects treated with M923 vs Humira.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: 1. Proportion of subjects with response by static Physician Global Assessment (sPGA) of clear or almost clear (6-point scale) at Week 16 in subjects treated with M923 vs EU RPP 2. PASI50, PASI75, PASI90, and sPGA response rates over time in subjects treated with M923 or EU RPP 3. Absolute PASI score over time in subjects treated with M923 and EU RPP 4. Health-related quality of life during treatment with M923 and EU RPP based on the Dermatology Life Quality Index (DLQI) and the EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) Safety: 1. Clinical safety and tolerability of M923 compared with EU RPP as assessed by vital signs, clinical laboratory results, electrocardiograms (ECGs), and AEs (including serious AEs [SAEs], withdrawal from the study besause of an AE, discontinuation of study-specific therapy because of an AE, and injection site reactions) 2. Clinical safety and tolerability of the transitions between EU RPP and M923 (occurring twice in arm B2) compared with continuous use of EU RPP (arm B1) Pharmacokinetics and Immunogenicity: 1. Exposure to M923 and EU RPP assessed as serum levels collected periodically throughout the treatment period 2. Immunogenicity of M923 and EU RPP assessed as proportion experiencing seroconversion, titer of anti-drug antibody (ADA) levels over time, and neutralizing ADA 3. Immunogenicity, as evidenced by the presence of ADAs, following the transition from EU RPP to M923 compared with continuous use of EU RPP assessed as proportion of subjects experiencing seroconversion; titer of ADA levels over time, and neutralizing ADA over time;Timepoint(s) of evaluation of this end point: Over the course of the study; | — |
Countries
Bulgaria, Canada, Czech Republic, Estonia, Germany, Hungary, Latvia, Poland, Serbia, Slovakia, Turkey, United States
Contacts
Public ContactClinical Trial Information Desk
Momenta Pharmaceuticals, Inc
Outcome results
None listed