Moderate to Severe Plaque Psoriasis MedDRA version: 16.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: ABP 501
Product Code: ABP 501
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Not applicable
CAS Number: 1446410-95-2
Current Sponsor code: ABP 501
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has provided informed consent 2. Subject is between 18 and 75 years of age at time of screening 3. Subject has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the Investigator) 4. Subject has involved body BSA more than or equal to 10%, PASI more than or equal to 12, and static Physician’s Global Assessment (sPGA) more than or equal to 3 at screening and at baseline 5. For women (except those at least 2 years postmenopausal or surgically sterile): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline 6. Subject has no known history of active tuberculosis 7. Subject has a negative test for tuberculosis during screening defined as either: -negative purified protein derivative (PPD) (=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Skin disease related 1. Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis Other medical conditions 2. Subject has a planned 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-infectives were used within 28 days prior to first dose of investigational product -a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product -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 5. Hepatitis B surface antigen or Hepatitis C antibody positivity at screening 6. Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease, renal failure, liver disease, or hypertension 7. Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma 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 (New York Heart Association [NYHA] class III/IV) 10.Subject has a history of hypersensitivity to the active substance or to any of the excipients of adalimumab or ABP 501 11.Subject has any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is to evaluate the efficacy of ABP 501 in subjects with moderate to severe plaque psoriasis, as measured by the PASI percent improvement from baseline, compared with adalimumab.;Secondary Objective: The secondary objectives are to assess the safety and immunogenicity of ABP 501 compared with adalimumab and to assess efficacy in terms of PASI 75 response, static Physician’s Global Assessment (sPGA) and percent body surface area (BSA) affected. ;Primary end point(s): The primary efficacy endpoint is the PASI percent improvement.;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is the PASI percent improvement from baseline at week 16. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0–4 scale) of the lesions, weighted by the area of involvement | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include PASI 75 response, the PASI percent improvement , the sPGA responses (with 0 or 1 being a positive result), and BSA involvement. ;Timepoint(s) of evaluation of this end point: Secondary endpoints include PASI 75 response at weeks 16,32 and 50, the PASI percent improvement from baseline to weeks 32 and 50, the sPGA responses (with 0 or 1 being a positive result) at weeks 16, 32 and 50, and BSA involvement at weeks 16, 32 and 50. | — |
Countries
Australia, Canada, France, Germany, Hungary, Poland
Contacts
Public ContactIHQ Medical Info-Clinical Trials
Amgen (Europe) GmbH
Outcome results
None listed