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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 March 2022
• Main ID: NCT02714322
• Date of registration: 09/11/2015
• Prospective Registration: No
• Primary sponsor: Mylan Inc.
• Public title: MYL-1401A Efficacy and Safety Comparability Study to Humira®
• Scientific 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
• Date of first enrolment: June 2015
• Target sample size: 294
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02714322
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Estonia, Hungary, Poland, Russian Federation, Ukraine

Contacts

• Name: Abhijit Barve, MD
• Affiliation: Mylan

Key inclusion & exclusion 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-?
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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Arthritis, Psoriatic

Intervention(s)

Biological: MYL-1401A (Adalimumab)

Biological: Humira® (Adalimumab)

Primary Outcome(s)

Percent improvement in PASI from Baseline [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Number of subjects achieving static Physician's Global Assessment (sPGA) responses of clear (0) or almost clear (1) [Time Frame: Week 12]

Proportion of subjects showing at least a 75% improvement in PASI (PASI 75 response rate) [Time Frame: Week 12]

Secondary ID(s)

2014-003420-46

MYL-1401A-3001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mylan GmbH