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

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ClinicalTrials.gov Identifier: NCT03849404
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Alvotech Swiss AG

Brief Summary:
Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Biological: Adalimumab Phase 3

Detailed Description:

A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS).

This study will be conducted at about 40 study centers in central and eastern European countries. A contract research organization, will oversee operational aspects of this study on behalf of Alvotech Swiss AG (Alvotech), the Sponsor of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double blind study.
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: AVT02 100mg/mL (Adalimumab Biosimilar)
Patients will be randomized to AVT02 on 1: 1 basis from the dosing day of Day 1 until week 48
Biological: Adalimumab
Patients in AVT02 arm will receive an initial loading dose of AVT02 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) starting 1 week after the loading dose, and will continue to receive AVT02 until Week 48 Patients in EU-Humira arm will receive an initial loading dose of Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW starting 1 week after the loading dose and will continue to receive Humira until Week 48

Experimental: EU-Humira 100mg/mL (Adalimumab Originator)
Patients will be randomized to EU-Humira on 1: 1 basis from the dosing day of Day 1 until week 48
Biological: Adalimumab
Patients in AVT02 arm will receive an initial loading dose of AVT02 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) starting 1 week after the loading dose, and will continue to receive AVT02 until Week 48 Patients in EU-Humira arm will receive an initial loading dose of Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW starting 1 week after the loading dose and will continue to receive Humira until Week 48




Primary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline to Week 16 ]
    Percent (%) change in Psoriasis Area and Severity Index (PASI)


Secondary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) [ Time Frame: Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50 ]
    Percent (%) change in Psoriasis Area and Severity Index (PASI)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patient 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 BL.
  • Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
  • Patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB).

Exclusion Criteria:

  • Patient has prior use of 2 or more biologics for treatment of PsO.
  • 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 drug on psoriasis.
  • Patient has prior use of any of the following medications within specified time periods or will require use during the study:

    1. Topical medications within 2 weeks of BL (Week 1).
    2. PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit.
    3. Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the BL Visit.
    4. Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational.
    5. Any systemic steroid in the 4 weeks prior to BL.

Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened and randomized per the list in the protocol


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): NCT03849404


Contacts
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Contact: Roshan Director, Clinical Operations, MSc +41786595945 roshan.dias@alvotech.com
Contact: Heimo Medical Monitor, MD +49 2461 690586 Heimo.Stroissnig@alvotech.com

Locations
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Estonia
Innomedica OU Recruiting
Tallin, Estonia, 10117
Contact: Jaak Principal Investigator, MD    3726109434    jaak.talli@innomedica.ee   
Sponsors and Collaborators
Alvotech Swiss AG
Investigators
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Principal Investigator: Steven Feldman, MD, PhD Wake Forest University Health Sciences

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Responsible Party: Alvotech Swiss AG
ClinicalTrials.gov Identifier: NCT03849404     History of Changes
Other Study ID Numbers: AVT02-GL-301
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents