Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis

NCT04453137 | Completed Phase 3

• 1 other identifier: AVT02-GL-302
• Study Type: interventional
• Target: 567
• Locations: 5 countries
• Sites: 25

Brief Summary

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve over the dosing interval from Week 26 to Week 28 (AUCtau,26-28)

  Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUCtau, 26-28) of AVT02 and Humira

  Week 26 to Week 28

• Maximum concentration over the dosing interval from Week 26 to Week 28 (Cmax, 26-28)

  Venous blood samples will be collected for measurement of serum concentration of AVT02 and Humira

  Week 26 to Week 28

Secondary Outcomes (1)

• Psoriasis Area and severity index

  Week 1 to Week 28 and week 12 to Week 28

Study Arms (4)

Humira 40 mg/mL (Adalimumab Originator)

ACTIVE COMPARATOR

During the LeadIn Period, patients will receive Humira (initial dose of 80 mg \[2 × 40 mg\] administered subcutaneously \[SC\], followed by 40 mg SC given every other week starting 1 week after the initial dose). At Week 12, responsive patients (Psoriasis Area and Severity Index \[PASI\] ≥ 75 \[PASI75\]) will be randomly assigned in a 1:1 ratio to either of the following groups for participation in the Double-Blind Switching Module.

Biological: Adalimumab originator

IC - Humira 40 mg/mL (Adalimumab Originator)

ACTIVE COMPARATOR

patients continue to receive Humira 40 mg every other week from Week 12 until Week 26 (8 injections)

Biological: Adalimumab originator

IC - Humira/AVT02 40 mg/mL (Adalimimab Biosimilar)

EXPERIMENTAL

patients undergo repeated switches (Sw) of AVT02 and Humira from Week 12 until Week 26: * Sw1-AVT02 (40 mg every other week) for 4 weeks (2 injections), * Sw2-Humira (40 mg every other week) for 4 weeks (2 injections), * Sw3-AVT02 (40 mg every other week) for 8 weeks (4 injections).

Biological: Adalimumab originator; Biological: Adalimumab biosimilar

AVT02 40 mg/mL (Adalimimab Biosimilar)

EXPERIMENTAL

At Week 28, after the EoS IC visit, responsive patients (PASI ≥ 50 \[PASI50\]) will be offered to continue with the optional open-label Extension Phase (Weeks 28 to 52). AVT02 40 mg will be administered every other week starting from Week 28 (after completing EoS IC assessments), ending with the final study drug administration at Week 50. The EoS visit is planned for Week 52.

Biological: Adalimumab biosimilar

Interventions

Adalimumab originator BIOLOGICAL

Subcutaneous injection every other week

Also known as: Humira

Humira 40 mg/mL (Adalimumab Originator); IC - Humira 40 mg/mL (Adalimumab Originator); IC - Humira/AVT02 40 mg/mL (Adalimimab Biosimilar)

Adalimumab biosimilar BIOLOGICAL

Subcutaneous injection every other week

Also known as: AVT02

AVT02 40 mg/mL (Adalimimab Biosimilar); IC - Humira/AVT02 40 mg/mL (Adalimimab Biosimilar)

Eligibility Criteria

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

You may qualify if:

• Patient has signed the informed consent form and documentation as required by relevant competent authorities and is able to understand and adhere to the visit schedule and study requirements.
• Patient is male or female aged 18 to 75 years, inclusive, at the time of Screening.
• Patients with moderate-to-severe chronic plaque psoriasis who has involved body surface area (BSA) ≥ 10% (Palm Method), ≥ 12 on the PASI, and static Physicians Global Assessments (sPGA) ≥ 3 (moderate) at Screening and at Baseline (Week 1/Day 1).
• Patient has had stable disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
• Patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
• Patient is naive to adalimumab therapy, approved or investigational.
• Patient has a negative QuantiFERON test for tuberculosis (TB) during Screening. Note: Patients with an indeterminate QuantiFERON test are allowed if they have all of the following:
• No evidence of active TB on chest radiograph within 3 months prior to the first dose of study drug.
• Documented history of treatment of TB or adequate prophylaxis initiation with an isoniazid-based regimen \> 1 month prior to receiving study drug in accordance with local recommendations.
• No known exposure to active TB after most recent prophylaxis.
• Asymptomatic at Screening and Baseline. Investigators should check with the medical monitor before enrolling such subjects.
• Women of childbearing potential (except those who are postmenopausal for more than 2 years or if surgically sterile) must have a negative serum pregnancy test during Screening and negative urine pregnancy test at Baseline (Week 1/Day 1).
• Sexually active women of childbearing potential must agree to use highly effective contraception (sterilization, hormonal contraception pills or injection or implants, sterilization and abstinence) for the duration of the study and until 6 months after the last dose of the study drug. Male patients must agree to use contraception for the duration of the study and agree not to donate sperm during and for 6 months after the last dose of study drug.

You may not qualify if:

• Patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, 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 of psoriasis.
• Patient has prior use of any of the following medications within specified time periods or will require use during the study:
• Topical medications within 2 weeks of Baseline (Week 1/Day 1). PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the Baseline (Week 1/Day 1).
• Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the Baseline (Week 1/Day 1).
• Any prior or concomitant adalimumab therapy, either approved or investigational.
• Any systemic steroid in the 4 weeks prior to Screening.
• Investigational agent(s) within 90 days or 5 half-lives (whichever is longer) before Baseline (Week 1/Day 1) (Refer to the following table for approved/marketed products).
• Specified washout periods are as follows:
• Adalimumab: not allowed
• Alefacept, Briakinumab, Brodalumab, Golimumab: 24 weeks
• Ustekinumab: 15 weeks
• Etanercept , Secukinumab , Infliximab , Certolizumab, Pegol: 12 weeks
• Cyclosporine: 4 weeks
• Methotrexate: 4 weeks
• PUVA-UVA/UVB: 4 weeks

Sponsors & Collaborators

• Alvotech Swiss AG: lead

Study Sites (25)

9901

Tbilisi, Georgia

Location

Alvotech Swiss AG - 9904

Tbilisi, Georgia

Location

Alvotech Swiss AG - Site 9902

Tbilisi, Georgia

Location

Alvotech Swiss AG - Site 9903

Tbilisi, Georgia

Location

Alvotech Swiss AG - Site 3501

Reykjavik, Iceland

Location

Alvotech Swiss AG - Site 4803

Gdansk, Poland

Location

Alvotech Swiss AG - Site 4804

Krakow, Poland

Location

Alvotech Swiss AG - Site 4807

Krakow, Poland

Location

Alvotech Swiss AG - Site 4805

Lodz, Poland

Location

Alvotech Swiss AG - Site 4806

Torun, Poland

Location

Wromedica Centrum Zdrowia

Wroclaw, 51-685, Poland

Location

Alvotech Swiss AG - 4808

Wroclaw, Poland

Location

Alvotech Swiss AG - Site 7001

Kemerovo, Russia

Location

Alvotech Swiss AG - Site 7005

Krasnodar, Russia

Location

Alvotech Swiss AG - Site 7003

Saint Petersburg, Russia

Location

Alvotech Swiss AG - Site 7004

Saint Petersburg, Russia

Location

Alvotech Swiss AG - Site 7006

Saint Petersburg, Russia

Location

Alvotech Swiss AG - Site 7002

Saratov, Russia

Location

Alvotech Swiss AG - Site 3805

Kharkiv, Ukraine

Location

Alvotech Swiss AG - Site 3807

Kharkiv, Ukraine

Location

Alvotech Swiss AG - Site 3801

Kyiv, Ukraine

Location

Alvotech Swiss AG - Site 3806

Kyiv, Ukraine

Location

Alvotech Swiss Ag - Site 3802

Rivne, Ukraine

Location

Alvotech Swiss AG - Site 3804

Uzhhorod, Ukraine

Location

Alvotech Swiss AG - Site 3803

Zaporizhzhya, Ukraine

Location

Related Publications (1)

• Feldman SR, Kay R, Reznichenko N, Sobierska J, Dias R, Otto H, Haliduola HN, Sattar A, Ruffieux R, Stroissnig H, Berti F. Assessing the Interchangeability of AVT02 and Humira(R) in Participants with Moderate-to-Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study. BioDrugs. 2023 Jul;37(4):551-567. doi: 10.1007/s40259-023-00600-x. Epub 2023 May 19.

  PMID: 37204631 DERIVED

MeSH Terms

Interventions

Adalimumab; adalimumab biosimilar HS016

Intervention Hierarchy (Ancestors)

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

Study Officials

• Steven Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open label lead-in phase, followed by blinded 1:1 randomization with open label extension phase.

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: July 1, 2020
• Study Start: June 30, 2020
• Primary Completion: May 31, 2021
• Study Completion: November 16, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1); UA (7); RU (6); PL (7); GE (4)