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

NCT02714322 | Completed Phase 3

• 2 other identifiers: MYL-1401A-30012014-003420-46
• Study Type: interventional
• Target: 294
• Locations: 6 countries
• Sites: 33

Brief Summary

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

Conditions

Psoriasis; Arthritis, Psoriatic

Keywords

Adalimumab; Biologics; Biosimilar

Outcome Measures

Primary Outcomes (1)

• Percent improvement in PASI from Baseline

  Baseline and Week 12

Secondary Outcomes (2)

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

  Week 12

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

  Week 12

Study Arms (2)

MYL-1401A (Adalimumab)

EXPERIMENTAL

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)

Humira® (Adalimumab)

ACTIVE COMPARATOR

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)

Interventions

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

MYL-1401A (Adalimumab)

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

Humira® (Adalimumab)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan GmbH: collaborator

Study Sites (33)

Mylan Investigational Site 102

Plovdiv, Bulgaria

Location

Mylan Investigational Site 105

Plovdiv, Bulgaria

Location

Mylan Investigational Site 101

Sevlievo, Bulgaria

Location

Mylan Investigational Site 100

Sofia, Bulgaria

Location

Mylan Investigational Site 103

Sofia, Bulgaria

Location

Mylan Investigational Site 107

Tallinn, Estonia

Location

Mylan Investigational Site 108

Tallinn, Estonia

Location

Mylan Investigational Site 109

Tallinn, Estonia

Location

Mylan Investigational site 110

Tallinn, Estonia

Location

Mylan Investigational Site 106

Tartu, Estonia

Location

Mylan Investigational SIte 112

Tartu, Estonia

Location

Mylan Investigational Site 127

Budapest, Hungary

Location

Mylan Investigational Site 128

Budapest, Hungary

Location

Mylan Investigational Site 125

Debrecen, Hungary

Location

Mylan Investigational Site 129

Gyula, Hungary

Location

Mylan Investigational Site 126

Szekszárd, Hungary

Location

Mylan Investigational Site 131

Bialystok, Poland

Location

Mylan Investigational Site 137

Bialystok, Poland

Location

Mylan Investigational Site 135

Iwonicz-Zdrój, Poland

Location

Mylan Investigational Site 140

Krakow, Poland

Location

Mylan Investigational Site 139

Lodz, Poland

Location

Mylan Investigational Site 133

Olsztyn, Poland

Location

Mylan Investigational Site 138

Poznan, Poland

Location

Mylan Investigational Site 136

Warsaw, Poland

Location

Mylan Investigational Site 130

Wroclaw, Poland

Location

Mylan Investigational Site 132

Wroclaw, Poland

Location

Mylan Investigational Site 134

Wroclaw, Poland

Location

Mylan investigational site 156

Kazan', Russia

Location

Mylan Investigational site 155

Penza, Russia

Location

Mylan Investigational Site 148

Ryazan, Russia

Location

Mylan Investigational Site 149

Saint Petersburg, Russia

Location

Mylan Investigational site 159

Kharkiv, Ukraine

Location

Mylan investigational site 161

Uzhhorod, Ukraine

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Abhijit Barve, MD

  Mylan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: March 21, 2016
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (5); BU (5); ES (6); PL (11); UA (2); RU (4)