A randomized, double-blind, multicenter study to show similar efficacy and compare safety and immunogenicity of a biosimilar adalimumab (GP2017) and Humira® in patients with moderate to severe chronic plaque-type psioriasis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 448

Inclusion Criteria

1.Patients must be able to understand and communicate with the investigator and comply with the requirements of the study (including administration of s.c. injections) 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.
2.Men or women of at least 18 years of age at time of screening
3.Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
4.Moderate to severe psoriasis as defined at randomization by:
•PASI score of 12 or greater and,
•IGA score of 3 or greater (based on a scale of 0 - 4) and,
•Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater
5.Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.
6.Patient with the following laboratory values obtained during Screening :
a)hemoglobin = 10g/dL
b)white blood count (WBC) =3,500/µl/);
c)platelet count = 125,000/µl
d)neutrophils = 2000/µl
e)AST, ALT and AP = 2.5 xULN; .
f)serum creatinine level <176.8 µmol/L (2.0 mg/dL)
g)Negative test for serologic or virologic markers for active or latent Hepatitis B (HBV) and/or Hepatitis C (HCV) infections
h) Negative QuantiFERON®-TB Gold test (QFT)

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 403
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1.Forms of psoriasis other than chronic plaque-type
2.Ongoing use of prohibited psoriasis treatments
3.Previous exposure to adalimumab
4.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG)
laboratory test (cut-off as defined by central laboratory)
5.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
6. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment of adalimumab
7.Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator
significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy
8.Pre-existing or recent-onset of central of peripheral nervous system demyelinating disorders according to investigator's discretion and taking into account a neurological assessment; patients who are considered to
have an increased risk of developing a demyelinating disease
9.Significant cardiovascular problems, including but not limited to the following: uncontrolled hypertension (= 160 systolic/95 diastolic mm Hg), congestive heart failure with known decreased left ventricular
ejection fraction
10.Bi-directional chest X-ray, chest high resolution computerized tomography (HR-CT) scan or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process obtained within 12 weeks prior to randomization, and evaluated by a qualified physician. If subjects do not have an image available at the time of screening, a bi-directional chest X-ray must be done prior to randomization after it is fairly certain the patient meets the other inclusion/exclusion criteria in order to minimize unnecessary exposure to X-ray radiation for patients.
11.History of an ongoing, chronic or recurrent infectious disease. History of active TB. Presence of latent (inactive) TB detected by imaging or by the QuantiFERON®-TB Gold test (QFT) at screening.
12.Active systemic infections during the last two weeks (exception: common cold) prior to randomization and any infections that reoccur on a regular basis; patients with a history or evidence of opportunistic infections
13.Past medical history record of infection with human immunodeficiency virus (HIV)
14.History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months before screening, and except for carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
15.Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method