Moderate to Severe Plaque Psoriasis MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Adalimumab
Product Code: ONS-3010
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: ONS-3010
Sponsors
Oncobiologics Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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/?L), platelets <100 x 10^9/L (100,000/?L) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 16.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoints The secondary efficacy endpoints are as follows: - PASI 75 and PASI 90 response rates over time - PASI value and change in PASI from baseline at each visit - Change from baseline in sPGA at each visit - Percentage of patients with sPGA of 0 (clear) or 1 (almost clear) at each visit Safety Endpoints The safety endpoints of this study are as follows: ? Incidence of TEAEs and SAEs ? Incidence of adverse events (AEs) of special interest: o Serious infections o Malignancies o Injection site reactions ? Incidence of circulating ADAs ? Incidence of neutralizing antibodies ? Clinically significant changes in laboratory values;Timepoint(s) of evaluation of this end point: - PASI 75 and PASI 90 response rates over time - PASI value and change in PASI from baseline at each visit - Change from baseline in sPGA at each visit - Percentage of patients with sPGA of 0 (clear) or 1 (almost clear) at each visit | — |
Countries
Australia, Bulgaria, Canada, Chile, France, Germany, Hungary, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactElizabeth Yamashita
Oncobiologics Limited
Outcome results
None listed