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

Phase 1

• Conditions: Moderate to severe chronic plaque-type psoriasis; MedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-000747-11-PL
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-11
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

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

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 324
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

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. If presence of latent tuberculosis (TB) is detected by imaging, then TB treatment must have been initiated and maintained according to local country guidelines prior to randomization
11.History of an ongoing, chronic or recurrent infectious disease, or evidence of TB infection as defined by a positive QuantiFERON®-TB Gold test (QFT) at screening. Patients with a positive or indeterminate QFT test may participate in the study if full tuberculosis work up (according to local practice/guidelines) completed within 12 weeks establishes conclusively that the patient has no evidence of active TB. If presence of latent TB is established, then TB treatment must have been initiated and maintained according to local country guidelines prior to randomization
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 carcino

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate equivalent efficacy of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI75 response rate at Week 16;Secondary Objective: Key secondary objectives:<br>•For treatment period 1: To compare PASI50, PASI75, PASI90 and PASI100 response rates of patients treated with GP2017 and Humira®<br>•For treatment period 2: to compare efficacy, safety and immunogenicity of pooled data from patients undergoing repeated switches (Groups 1b and 2b) with those from patients constantly treated with GP2017 (Group 1a) and Humira® (Group 2a)<br>;Primary end point(s): The primary efficacy variable is the PASI 75 response rate (proportion of subjects showing at least a 75% improvement PASI at Week 16 in Treatment Period 1);Timepoint(s) of evaluation of this end point: Week 16 of Treatment Period 1