A Randomized, Double-Blind, Multicenter, Equivalence Study of ONS-3010 and Humira® for the Treatment of Patients with Moderate to Severe Plaque Psoriasis
- Conditions
- Moderate to Severe Plaque PsoriasisMedDRA version: 19.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-004614-26-HU
- Lead Sponsor
- Oncobiologics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 452
Patients must meet all of the following inclusion criteria to participate in
the study:
1. Men or women at least 18 years of age at the time of screening
2. Chronic plaque-type psoriasis diagnosed for at least 6 months before
randomization and stable for at least 2 months before screening.
Patients will be considered to have stable disease if there have been no
new lesions while other lesions remain significantly the same, even if the
affected surface area is extensive.
3. Moderate to severe psoriasis as defined at screening and baseline by
meeting all of the following criteria:
o PASI score of 12 or greater
o sPGA score of 3 or greater (based on a scale of 0 to 5)
o BSA affected by plaque-type psoriasis of 10% or greater
4. 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
5. Women of childbearing potential and all males must use an acceptable
form of birth control throughout the study. Women of childbearing
potential must agree to continue using birth control for 5 months after
the last dose. Acceptable methods of birth control include surgery
(bilateral tubal ligation, vasectomized partner), hormonal contraceptive
(oral, patch, injectable, implantable, intravaginal), intrauterine device,
or double physical barrier such as condom plus diaphragm. Postmenopausal status for >1 year will also satisfy this requirement. Also, males are not to donate sperm during the study or for 16 weeks after the last dose.
6. Ability and willingness to self-administer study drug
7. Ability to read and understand the informed consent form and provide written consent
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 298
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 154
Patients who meet any of the following criteria are ineligible to participate in this study:
1. Forms of psoriasis other than chronic plaque-type
2. Drug-induced psoriasis
3. Ongoing use of prohibited psoriasis treatments. Washout periods prior to baseline (first dose of study drug) for prior psoriasis treatments are as follows:
o =2 weeks for topical medications and ultraviolet B (UVB) phototherapy
o =4 weeks for psoralen plus ultraviolet A (UVA) phototherapy
o =4 weeks for nonbiologic systemic therapies
o =12 weeks for other biologic therapies
o =12 months for alkylating agents
4. Exposure to live or live-attenuated vaccines within 8 weeks prior to the screening visit
5. Previous exposure to adalimumab
6. Treatment with an investigational agent within 12 weeks or 5 half-lives of the drug prior to screening, whichever is longer
7. Prior treatment with TNF inhibitors with lack of efficacy as per clinical judgment (primary failure)
8. Major surgery within 8 weeks prior to screening or planned to take place during the study period
9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of study treatment
10. History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
11. History of neurological symptoms suggestive of central nervous system demyelinating disease
12. Acute infection requiring treatment with parenteral antibiotics within 4 weeks prior to baseline (first dose of study drug) or oral/topical antibiotics within 2 weeks prior to baseline
13. History of human immunodeficiency virus 1 or 2, hepatitis B, or hepatitis C
14. Presence of chronic or acute infection at screening, including positive result for active TB or untreated latent TB (eg, positive QuantiFERON® test result without any prior history of active or latent TB, and without evidence of active infection), where the patient is not willing to undergo prophylactic treatment (see Section 11.3)
15. History of chronic infection or infections within the past 2 years requiring hospitalization or administration of intravenous antibiotics (without evidence of a cure)
16. Known hypersensitivity or history of anaphylactoid reaction(s) to adalimumab or its excipients
17. Presence of New York Heart Association (NYHA) Class III/IV heart failure (see Section 11.5)
18. History of congestive heart failure, recent cerebrovascular accident, or any other condition that, in the opinion of the Investigator, would put the patient at risk by participation in the study
19. History of clinically significant cardiac, respiratory (except for mild asthma), renal, hepatic, hematologic, gastrointestinal, neurologic, or psychiatric disease or disorder, or any other uncontrolled medical illness
20. Pregnant, a positive pregnancy test, or intending to become
pregnant during or within 5 months after completion of the study, or
breastfeeding
21. Impaired bone marrow or hepatic or renal function, including the
following:
o Hemoglobin <7.14 mmol/L (11.5 g/dL) for males or <6.21 mmol/L
(10.0 g/dL) for females, absolute neutrophil count <1.5 x 10^9/L (1500
cells/µL), platelets <100 x 10^9/L (100,000/µL)
o Total bilirubin =1.5 x ULN, excluding cases where elevated bilirubin
can be attributed to Gilbert's syndrome
o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
=1.5 x ULN
o Creatinine =1.5 x ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the therapeutic equivalence of ONS-3010 (adalimumab biosimilar) compared to Humira (adalimumab) in patients with plaque psoriasis;Secondary Objective: To assess the safety, tolerability, and immunogenicity of ONS-3010 compared to Humira in patients with plaque psoriasis;Primary end point(s): The primary endpoint of this study is the PASI 75 response rate at Week 17.;Timepoint(s) of evaluation of this end point: Week 17
- Secondary Outcome Measures
Name Time Method