Chronic Plaque-Psoriasis MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: MYL-1401A
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: MYL-1401A
Other descriptive name
Sponsors
Mylan GmbH (Mylan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject must meet all of the following criteria to be enrolled in this study: 1. Subject has signed the ICF and documentation as required by relevant competent authorities and is able to understand and adhere to the visit schedule and study requirements 2. Subject is aged 18 to 75 years, inclusive, at time of Screening 3. Subject has had moderate to severe chronic plaque psoriasis for at least 6 months a) Subject has involved BSA =10%, PASI =12, and sPGA =3 (moderate) at Screening and at Baseline 4. Subject has had stable disease for at least 2 months (i.e. without significant changes as defined by the investigator) 5. Subject is a candidate for systemic therapy or phototherapy 6. Subject has had a previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy (e.g. methotrexate, cyclosporine, psoralen plus ultra violet [UV] A [PUVA], UVB) 7. Subject is naïve to adalimumab therapy, approved or investigational 8. For female subjects of childbearing potential, a negative serum pregnancy test during Screening and a negative urine pregnancy test at Baseline Note: Childbearing potential is defined as any female subject who has experienced menarche and is not postmenopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (however, women who have been surgically sterilized by bilateral oophorectomy or bilateral tubal ligation within the last 6 months must also have a negative pregnancy test at Screening to be considered of nonchildbearing potential). All other women will be considered to be of childbearing potential and must be using an acceptable contraceptive method as described in detail in Inclusion Criterion no. 9. 9. Fertile male and female subjects participating in heterosexual relations must be willing to use adequate contraception (i.e. 2 effective methods, one of which must be a physical barrier method) from Screening until 5 months after their last dose of study treatment; or must be sexually inactive by abstinence, which is consistent with the preferred and usual lifestyle of the subject a) Effective forms of contraception are a condom, an established form of hormonal contraception, a diaphragm or cervical/vault cap or an intrauterine device. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. b) Sterile males and females and subjects who have same-sex sexual relations do not have to use contraception. Sterile males and females must be surgically sterile for at least 6 months or postmenopausal (females) at least 2 years. 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 264 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: Skin disease related: 1. Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (e.g. eczema), or other systemic autoimmune disorder inflammatory disease at the time of the screening visit that would interfere with evaluations of the effect of the study treatment on psoriasis Prior and concomitant medications: 2. Subject has used any of the following medications within specified time periods or will require their use during the study: a) Topical medications within 2 weeks before the end of the screening period b) PUVA phototherapy and/or UVB phototherapy within 4 weeks before the end of the screening period c) Nonbiologic systemic therapies within 4 weeks before the end of the screening period (e.g. cyclosporine, methotrexate, and acitretin) d) Any prior or concomitant adalimumab therapy, approved or investigational e) Any other investigational agent within 90 days or 5 half-lives obefore the end of the screening period (whichever is longer) f) Any systemic steroid in the 4 weeks before the end of the screening period Note: Low-potency topical corticosteroids applied to the palms, soles, face, and intertriginous areas are permitted during study participation. 3. Subject has received live vaccines during the 4 weeks prior to Screening or has the intention of receiving a live vaccine at any time during the study Other medical conditions: 4. Subject has a positive test for TB during Screening or a known history of active or latent TB, except documented and complete adequate treatment of TB or initiation (>1 month) of adequate prophylaxis of latent TB, with an isoniazid-based regimen A positive test for TB during Screening is defined as either: - Positive purified protein derivative test (=5 mm of induration at 48 to 72 hours after test is placed) OR- Positive IGRA. Refer to protocol for Note Positive IGRA conditions. 5. 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 subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy 6. Subject has a planned surgical intervention during the duration of the study except those related to the underlying disease and which, in the opinion of the investigator, will not put the subject at further risk or hinder the subject’s ability to maintain compliance with study treatment and the visit schedule 7. Subject has any active and serious infection or history of infections as follows: - Any active infection - For which nonsystemic anti-infectives were used within 4 weeks prior to randomization. Note: Subjects receiving topical antibiotics for facial acne do not need to be excluded. - Requiring hospitalization or systemic anti-infectives within 8 weeks prior to randomization - 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 - Invasive fungal infection or mycobacterial infection - Opportunistic infections, such as listeriosis, legionellosis or pneumocystis 8. Subject is positive for HIV or HCV antibody or HBsAg or is positive for HBcAb and negative for HBsAg at Screening 9. Sub
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the equivalence of MYL-1401A to Humira® with regards to efficacy at Week 12 in subjects with moderate-to-severe chronic plaque psoriasis.;Secondary Objective: The secondary objectives of this study are: • To compare the efficacy of MYL-1401A and Humira® in subjects with moderate to severe chronic plaque psoriasis at Weeks 4,8, 12, 16, 24, and 52. • To compare the safety and tolerability of MYL-1401A and Humira® • To compare the immunogenicity of MYL-1401A and Humira® • To assess steady-state pharmacokinetics of MYL-1401A and Humira® ;Primary end point(s): The primary efficacy endpoint is the percent improvement in PASI from Baseline to Week 12 ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The key secondary efficacy endpoints are: • Proportion of subjects showing at least a 75% improvement in PASI (PASI 75 response rate) at Week 12 • Number and percentage of subjects achieving sPGA response of clear (0) or almost clear (1) at Week 12 - The additional secondary efficacy endpoints are: • PASI 75 response rate at Weeks 4,8,16, 24 and 52 • PASI 50, 90, and 100 response rates at Weeks 4,8,16, 24 and 52, 56,60,64 and 68 • Percent improvement in PASI from Baseline to Weeks 4,8,16, 24 and 52 • Number and percentage of subjects achieving sPGA response of clear (0) or almost clear (1) at Weeks 4,8,16,24 and 52 • Change from Baseline in body surface area (BSA) involvement at Weeks 4,8, 16, 24, and 52 • Change from Baseline in quality of life as measured by DLQI scores at Weeks 16, 24, and 52 - The safety endpoints are: • Frequency, type and severity of AEs, including ADRs • Frequency and severity of ISRs • Detection of antidrug antibodies to MYL-1401A or Humira® at Weeks 4, 8, 12, 16, 24, 42, 52 and follow-up • Routine safety parameters, including laboratory safety, vital sign measurements, 12 lead ECG and chest x-ray results, and physical examination findings - Pharmacokinetic Endpoint The PK endpoint is the serum trough concentrations of MYL-1401A and Humira®. - The exploratory endpoints are: • Concentration of PD marker hs-CRP at Week 16 • Change from Baseline in RAPID3 at Week 12 Additionally, immunogenicity will be assessed when subject displays signs or symptoms of immune -response-related AE(s) or in case of early discontinuation from the study;Timepoint(s) of evaluation of this end point: Endpoints will be assessed during the whole study till Follow-up visit (Weeks 4, 8, 12, 16, 24, 42 and 52). Please note not all endpoints will be assessed on each of the visits. | — |
Countries
Bulgaria, Estonia, Germany, Hungary, Poland, Russian Federation, Ukraine
Contacts
Public ContactClinial Development Lead
Mylan GmbH
Outcome results
None listed