Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03849404
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Alvotech Swiss AG

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE February 21, 2019
Last Update Posted Date February 21, 2019
Estimated Study Start Date  ICMJE February 18, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline to Week 16 ]
Percent (%) change in Psoriasis Area and Severity Index (PASI)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis
Official Title  ICMJE 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)
Brief Summary Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Biological: Adalimumab
  • 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
    Intervention: Biological: Adalimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roshan Director, Clinical Operations, MSc +41786595945 roshan.dias@alvotech.com
Contact: Heimo Medical Monitor, MD +49 2461 690586 Heimo.Stroissnig@alvotech.com
Listed Location Countries  ICMJE Estonia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03849404
Other Study ID Numbers  ICMJE AVT02-GL-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alvotech Swiss AG
Study Sponsor  ICMJE Alvotech Swiss AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Feldman, MD, PhD Wake Forest University Health Sciences
PRS Account Alvotech Swiss AG
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP