Moderate to Severe Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Code: ABP 501-HCF
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is male or female and is = 18 and = 75 years of age inclusive, at the time of enrollment. 2. Subject has moderate to severe Ps (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator). 3. Subject has a score of PASI = 12, involvement of = 10% body surface area (BSA) and static Physician’s Global Assessment (sPGA) = 3 at screening and at baseline. 4. Subject is a candidate for phototherapy or systemic therapy, when other systemic therapies are clinically less appropriate. 5. Female subject (except if postmenopausal or surgically sterile): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline. 6. Subject or legally acceptable representative is capable of giving signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent. 7. Subject has no known history of latent or active tuberculosis. Subject must meet any 1 of the following 3 criteria: • Subject has a negative test for tuberculosis during screening, defined as either: o Negative purified protein derivative (PPD); =65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: Skin Disease Related Conditions 1. Subject has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of screening (eg eczema) that would interfere with evaluations of the effect of investigational product of psoriasis. Other Medical Conditions 2. Subject has a planned major surgical intervention during the duration of the study. 3. Subject has an active infection or history of infections, as follows: • Any active infection for which systemic anti-infective therapy was used within 28 days prior to enrollment. • A serious infection, defined as requiring hospitalization or IV anti--infective therapy within 8 weeks prior to enrollment. • Opportunistic, recurrent or chronic infections, or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject. 4. Subject has known history of human immunodeficiency virus infection or has positive HIV serology at screening. 5. Subject has hepatitis B surface antigen, is positive for hepatitis B core antibody or has hepatitis C virus antibody positivity at screening. 6. Subject has uncontrolled, clinically significant systemic disease including, but not limited to metabolic disturbances including, uncontrolled diabetes mellitus, cardiovascular, renal, liver, pulmonary, gastrointestinal, hematologic, psychiatric disease, or hypertension. 7. Subject has known malignancy within the previous 5 years. 8. Subject has active neurological disease, such as multiple sclerosis, -Guillain-Barre syndrome, optic neuritis, transverse myelitis, or history of neurologic symptoms suggestive of central nervous system demyelinating disease. 9. Subject has moderate to severe heart failure, history of significant cardiac arrhythmia and/or cardiac hospitalization within 3 months prior to enrollment. 10. Subject has known hypersensitivity to the investigational products or to any of the excipients. 11. Subject has any concurrent medical condition, including hypersensitivity to any biologic medication, that, in the opinion of the investigator, could cause this study to be detrimental to the subject. Laboratory Abnormalities 12. Subject has laboratory abnormalities at screening, including any of the following: • Hemoglobin < 9 g/dL • Platelet count < 100,000/mm3 • White blood cell count < 3,000 cells/mm3 • Aspartate aminotransferase and/or alanine aminotransferase = 2.0 × the upper limit of normal • Creatinine clearance < 50 mL/min • Any other laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results Washouts and Non-permitted Drugs 13. Subject has previously received adalimumab or a biosimilar of adalimumab. 14. Subject has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment. 15. Subject has received any investigational agents within the previous month or 5 half-lives (whichever is longer) prior to enrollment. 16. Subject has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment. 17. Subject has received ultraviolet A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment. 18. Subject has received topical psoriasis treatment within 2 weeks prior to enrollment. 19. Subject has
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate similarity of PK in subjects after multiple switches between adalimumab and ABP 501, compared to subjects receiving continued-use of adalimumab. ;Secondary Objective: To assess the efficacy, safety, and immunogenicity in subjects after multiple switches between ABP 501 and adalimumab compared with subjects receiving continued-use of adalimumab. ;Primary end point(s): Pharmacokinetic parameters: • AUCtau between week 28 and week 30 • Cmax between week 28 and week 30.;Timepoint(s) of evaluation of this end point: • between week 28 and week 30 • between week 28 and week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic related Endpoints: • tmax between week 28 and week 30. • Ctrough between week 14 and week 28. Efficacy related Endpoints: • PASI percent improvement from baseline (day 1) to week 30. • PASI 75 response at week 30. • PASI 90 response at week 30. • PASI 100 response at week 30. Safety related Endpoints: • Treatment-emergent adverse events and serious adverse events, post randomization. • Events of interest, post randomization.;Timepoint(s) of evaluation of this end point: Pharmacokinetic related Endpoints: • between week 28 and week 30. • between week 14 and week 28. Efficacy related Endpoints: • from baseline (day 1) to week 30. • at week 30. • at week 30. • at week 30. Safety related Endpoints: • post randomization. • post randomization. | — |
Countries
Canada, Estonia, Germany, Hungary, Latvia, Poland, United States
Contacts
Public ContactProject Leadership
Parexel International (IRL) Limited
Outcome results
None listed