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Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT05510063 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2023-05-25

No results posted yet for this study

Summary

This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.

Conditions

Interventions

DRUG

Humira (Adalimumab)

Subcutaneous (SC) injection

DRUG

SB5 (Adalimumab Biosimilar)

Subcutaneous (SC) injection

Sponsors & Collaborators

  • Organon and Co

    collaborator INDUSTRY

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2023-04-04
Completion
2023-05-04

Countries

  • Bulgaria
  • Czechia
  • Lithuania
  • Poland

Study Locations

More Related Trials

Entities

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 NCT05510063 on ClinicalTrials.gov