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MYL-1401A Efficacy and Safety Comparability Study to Humira®

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ClinicalTrials.gov Identifier: NCT02714322
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with moderate-to-severe chronic plaque psoriasis

Condition or disease Intervention/treatment Phase
Psoriasis Arthritis, Psoriatic Biological: MYL-1401A (Adalimumab) Biological: Humira® (Adalimumab) Phase 3

Detailed Description:

Eligible subjects will be randomly assigned based on predefined stratification factors of weight, geographic region, and presence of psoriatic arthritis:

Randomization is 2:1 to MYL-1401A or Humira®, respectively.

The study will be conducted in the outpatient setting and comprises 3 periods: a screening period of up to 4 weeks, a 52-week treatment period, and a safety follow-up for 8 weeks.

A subject will be considered to have completed the study once they have completed the 52-week treatment period and the 8-week follow-up visit.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double-Blind, Randomized, 2-Arm, Parallel-Group, Equivalence Study Evaluating Efficacy and Safety Similarity of Mylan Adalimumab (MYL-1401A) Compared With Humira® in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis
Study Start Date : June 2015
Primary Completion Date : May 2016
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MYL-1401A (Adalimumab)
MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose
Biological: MYL-1401A (Adalimumab)
MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose
Active Comparator: Humira® (Adalimumab)
Humira® initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose
Biological: Humira® (Adalimumab)
Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose


Outcome Measures

Primary Outcome Measures :
  1. Percent improvement in PASI from Baseline [ Time Frame: Baseline and Week 12 ]

Secondary Outcome Measures :
  1. Proportion of subjects showing at least a 75% improvement in PASI (PASI 75 response rate) [ Time Frame: Week 12 ]
  2. Number of subjects achieving static Physician's Global Assessment (sPGA) responses of clear (0) or almost clear (1) [ Time Frame: Week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has signed the informed consent form
  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

    • 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
  6. Subject has had a previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy
  7. Subject is naïve to adalimumab therapy, approved or investigational
  8. For females of childbearing potential, a negative serum pregnancy test during Screening and a negative urine pregnancy test at Baseline

Exclusion Criteria:

  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
  2. Subject has used any of the following medications within specified time periods or will require their use during the study:

    • Topical medications within 2 weeks before the end of the screening period
    • oral psoralen with ultraviolet A (PUVA) phototherapy and/or ultraviolet B (UVB) phototherapy within 4 weeks before the end of the screening period
    • Nonbiologic systemic therapies within 4 weeks before the end of the screening period (e.g. cyclosporine, methotrexate, and acitretin)
    • Any prior or concomitant adalimumab therapy, approved or investigational
    • Any other investigational agent within 90 days or 5 half-lives of Screening (whichever is longer)
    • 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
  4. Subject has a positive test for tuberculosis (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

    • Subjects with a positive purified protein derivative (PPD) and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Interferon-γ release assays (IGRA)
    • Subjects with a positive PPD test without a history of Bacillus Calmette-Guérin vaccination or subjects with a positive or indeterminate IGRA are allowed if they have all of the following:
    • No symptoms or signs of active TB, including a negative chest x-ray within 3 months prior to the first dose of study treatment
    • Documented history of completion of adequate treatment of TB or initiation (>1 month) of adequate prophylaxis of latent TB, with an isoniazid-based regimen prior to receiving study treatment in accordance with local recommendations
  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 an 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.
    • 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 human immunodeficiency virus, hepatitis C virus antibody or hepatitis B surface antigen (HBsAg) or is positive for hepatitis B core antibody and negative for HBsAg at Screening
  9. Subject has a history of clinically significant hematological abnormalities, including cytopenias (e.g. thrombocytopenia, leukopenia)
  10. Subject has severe progressive or uncontrolled, clinically significant disease that in the judgment of the investigator renders the subject unsuitable for the study
  11. Subject has history of malignancy within 5 years except adequately treated cutaneous squamous or basal cell carcinoma, in situ cervical cancer or in situ breast ductal carcinoma
  12. Subject has active neurological disease such as multiple sclerosis, Guillain-Barré syndrome, optic neuritis, transverse myelitis, or history of neurologic symptoms suggestive of central nervous system demyelinating disease
  13. Subject has moderate-to-severe heart failure (New York Heart Association class III/IV)
  14. Subject has a history of hypersensitivity to the active substance or to any of the excipients of Humira® or MYL-1401A
  15. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
  16. Evidence of alcohol or drug abuse or dependency at the time of Screening, for the 5 years prior to Screening or during the study
  17. Subject is unable to follow study instructions and comply with the protocol in the opinion of the investigator
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714322


Locations
Bulgaria
Mylan Investigational Site 102
Plovdiv, Bulgaria
Mylan Investigational Site 105
Plovdiv, Bulgaria
Mylan Investigational Site 101
Sevlievo, Bulgaria
Mylan Investigational Site 100
Sofia, Bulgaria
Mylan Investigational Site 103
Sofia, Bulgaria
Estonia
Mylan Investigational Site 107
Tallinn, Estonia
Mylan Investigational Site 108
Tallinn, Estonia
Mylan Investigational Site 109
Tallinn, Estonia
Mylan Investigational site 110
Tallinn, Estonia
Mylan Investigational Site 106
Tartu, Estonia
Mylan Investigational SIte 112
Tartu, Estonia
Hungary
Mylan Investigational Site 127
Budapest, Hungary
Mylan Investigational Site 128
Budapest, Hungary
Mylan Investigational Site 125
Debrecen, Hungary
Mylan Investigational Site 129
Gyula, Hungary
Mylan Investigational Site 126
Szekszárd, Hungary
Poland
Mylan Investigational Site 131
Bialystok, Poland
Mylan Investigational Site 137
Bialystok, Poland
Mylan Investigational Site 135
Iwonicz-Zdroj, Poland
Mylan Investigational Site 140
Krakow, Poland
Mylan Investigational Site 139
Lodz, Poland
Mylan Investigational Site 133
Olsztyn, Poland
Mylan Investigational Site 138
Poznan, Poland
Mylan Investigational Site 136
Warsaw, Poland
Mylan Investigational Site 130
Wroclaw, Poland
Mylan Investigational Site 132
Wroclaw, Poland
Mylan Investigational Site 134
Wroclaw, Poland
Russian Federation
Mylan investigational site 156
Kazan, Russian Federation
Mylan Investigational site 155
Penza, Russian Federation
Mylan Investigational Site 148
Ryazan, Russian Federation
Mylan Investigational Site 149
St. Petersburg, Russian Federation
Ukraine
Mylan Investigational site 159
Kharkiv, Ukraine
Mylan investigational site 161
Uzhhorod, Ukraine
Sponsors and Collaborators
Mylan Inc.
Mylan GmbH
Investigators
Study Chair: Abhijit Barve, MD Mylan
More Information

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02714322     History of Changes
Other Study ID Numbers: MYL-1401A-3001
2014-003420-46 ( EudraCT Number )
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mylan Inc.:
Adalimumab
Biologics
Biosimilar

Additional relevant MeSH terms:
Psoriasis
Arthritis, Psoriatic
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents