A study to evaluate the similarity in efficacy and safety of Mylan Adalimumab (MYL-1401A) Compared With Humira® in Subjects With Moderate-to-Severe Chronic skin inflammatory disease.
- Conditions
- Chronic Plaque-PsoriasisMedDRA version: 19.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-003420-46-HU
- Lead Sponsor
- Mylan GmbH (Mylan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 294
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>• 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.<br>• To compare the safety and tolerability of MYL-1401A and Humira®<br>• To compare the immunogenicity of MYL-1401A and Humira®<br>• To assess steady-state pharmacokinetics of MYL-1401A and Humira®<br>;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 Outcome Measures
Name Time Method