The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psorasis

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2013-000537-12-PL
• Date of registration: 10/10/2013
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psorasis
• Scientific title: A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis.
• Date of first enrolment: 02/12/2013
• Target sample size: 340
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000537-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Canada, France, Germany, Hungary, Poland

Contacts

• Name: IHQ Medical Info-Clinical Trials
• Affiliation: Amgen (Europe) GmbH

• Name: IHQ Medical Info-Clinical Trials
• Affiliation: Amgen (Europe) GmbH

Key inclusion & exclusion 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) (< 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 within 3 months prior to screening
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

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Moderate to Severe Plaque Psoriasis
MedDRA version: 16.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Intervention(s)

Product Name: ABP 501
Product Code: ABP 501
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Not aplicable
CAS Number: 1446410-95-2
Current Sponsor code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Other descriptive name: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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

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.

Primary end point(s): The primary efficacy endpoint is the PASI percent improvement.

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.

Secondary Outcome(s)

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.

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.

Secondary ID(s)

2013-000537-12-HU

20120263

Source(s) of Monetary Support

Amgen Inc