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PsoriasisPhase 3NCT02714322

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

A Phase 3 study testing MYL-1401A (Adalimumab) and Humira® (Adalimumab) in people with Psoriasis and Arthritis, Psoriatic, run by Mylan Inc. at 33 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with moderate-to-severe chronic plaque psoriasis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis, Arthritis, Psoriatic
What is being tested?
MYL-1401A (Adalimumab) and Humira® (Adalimumab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
294 participants
Where
33 sitesin 6 countries
Study dates
Jun 2015to Mar 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has signed the informed consent form
  • Subject is aged 18 to 75 years, inclusive, at time of Screening
  • 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
  • Subject has had stable disease for at least 2 months (i.e. without significant changes as defined by the investigator)
  • Subject is a candidate for systemic therapy
Show all 9Show fewer
  • Subject has had a previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy
  • Subject is naïve to adalimumab therapy, approved or investigational
  • For females of childbearing potential, a negative serum pregnancy test during Screening and a negative urine pregnancy test at Baseline

Who cannot join

  • 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
  • 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
Show all 33Show fewer
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Subject has a history of clinically significant hematological abnormalities, including cytopenias (e.g. thrombocytopenia, leukopenia)
  • Subject has severe progressive or uncontrolled, clinically significant disease that in the judgment of the investigator renders the subject unsuitable for the study
  • 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
  • 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
  • Subject has moderate-to-severe heart failure (New York Heart Association class III/IV)
  • Subject has a history of hypersensitivity to the active substance or to any of the excipients of Humira® or MYL-1401A
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
  • Evidence of alcohol or drug abuse or dependency at the time of Screening, for the 5 years prior to Screening or during the study
  • Subject is unable to follow study instructions and comply with the protocol in the opinion of the investigator

Trial locations and contacts

33 sites in 6 countries.

33 sites in 6 countries

Poland11 sites

  • Mylan Investigational Site 131

    Bialystok

  • Mylan Investigational Site 137

    Bialystok

  • Mylan Investigational Site 135

    Iwonicz-Zdrój

  • Mylan Investigational Site 140

    Krakow

  • Mylan Investigational Site 139

    Lodz

  • Mylan Investigational Site 133

    Olsztyn

  • Mylan Investigational Site 138

    Poznan

  • Mylan Investigational Site 136

    Warsaw

  • Mylan Investigational Site 130

    Wroclaw

  • Mylan Investigational Site 132

    Wroclaw

  • Mylan Investigational Site 134

    Wroclaw

Other trials in Poland

Estonia6 sites

  • Mylan Investigational Site 107

    Tallinn

  • Mylan Investigational Site 108

    Tallinn

  • Mylan Investigational Site 109

    Tallinn

  • Mylan Investigational site 110

    Tallinn

  • Mylan Investigational Site 106

    Tartu

  • Mylan Investigational SIte 112

    Tartu

Other trials in Estonia

Bulgaria5 sites

  • Mylan Investigational Site 102

    Plovdiv

  • Mylan Investigational Site 105

    Plovdiv

  • Mylan Investigational Site 101

    Sevlievo

  • Mylan Investigational Site 100

    Sofia

  • Mylan Investigational Site 103

    Sofia

Other trials in Bulgaria

Hungary5 sites

  • Mylan Investigational Site 127

    Budapest

  • Mylan Investigational Site 128

    Budapest

  • Mylan Investigational Site 125

    Debrecen

  • Mylan Investigational Site 129

    Gyula

  • Mylan Investigational Site 126

    Szekszárd

Other trials in Hungary

Russia4 sites

  • Mylan investigational site 156

    Kazan'

  • Mylan Investigational site 155

    Penza

  • Mylan Investigational Site 148

    Ryazan

  • Mylan Investigational Site 149

    Saint Petersburg

Other trials in Russia

Ukraine2 sites

  • Mylan Investigational site 159

    Kharkiv

  • Mylan investigational site 161

    Uzhhorod

Other trials in Ukraine

About this study

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

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

Read the 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.

Being tested
MYL-1401A (Adalimumab), Humira® (Adalimumab)
Keywords
Adalimumab, Biologics, Biosimilar
Medical subject headings
Psoriasis, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MYL-1401A (Adalimumab)Biological

    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

  • Humira® (Adalimumab)Biological

    Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose

Study groups in NCT02714322
Study groupRoleWhat they receive
MYL-1401A (Adalimumab)ExperimentalMYL-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
Receives: Biological: MYL-1401A (Adalimumab)
Humira® (Adalimumab)Active comparatorHumira® initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose
Receives: Biological: Humira® (Adalimumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent improvement in PASI from Baseline

    Measured: Baseline and Week 12

Secondary outcomes (2)

  1. Proportion of subjects showing at least a 75% improvement in PASI (PASI 75 response rate)

    Measured: Week 12

  2. Number of subjects achieving static Physician's Global Assessment (sPGA) responses of clear (0) or almost clear (1)

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionMay 2016
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02714322
Sponsor's protocol ID
MYL-1401A-3001
Other IDs
2014-003420-46, 2014
Status last verified
Mar 2022
First submitted
9 Nov 2015
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MYL-1401A (Adalimumab) and Humira® (Adalimumab) in people with Psoriasis and Arthritis, Psoriatic, run by Mylan Inc. at 33 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Poland, Estonia, Bulgaria, Hungary, Russia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent improvement in PASI from Baseline (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714322.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.

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