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

NCT03849404 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2020-07-28

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Alvotech Swiss AG

    lead INDUSTRY

Principal Investigators

  • Steven Feldman, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2019-12-23
Completion
2020-07-20

Countries

  • Estonia
  • Georgia
  • Poland
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849404 on ClinicalTrials.gov