The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis
- Conditions
- Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Moderate to Severe Plaque PsoriasisMedDRA version: 16.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
- Registration Number
- EUCTR2013-000537-12-FR
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
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) (< 5 mm of induration at 48 to 72 hours
after test is placed)
OR
-negative Quantiferon test
8. Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test
9. Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
-no symptoms per tuberculosis worksheet provided by the Sponsor, Amgen
-documented history of adequate prophylaxis initiation prior to receiving study drug in
accordance with local recommendations
-no known exposure to a case of active tuberculosis after most recent prophylaxis
-no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
10. Subject is a candidate for systemic therapy or phototherapy
11. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy (eg, methotrexate, cyclosporine, psoralen plus ultraviolet light [UV] A)
12. Subject is able to complete study procedures
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 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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, PASI percent change, static Physician’s Global Assessment (sPGA) and percent body surface area (BSA) affected.<br>;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 Outcome Measures
Name Time Method 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 and 50, the PASI percent improvement from baseline to week 50, the sPGA responses (with 0 or 1 being a positive result) at weeks 16 and 50, and BSA involvement at weeks 16 and 50.