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A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

NCT05073315 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2024-02-09

Study results available
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Summary

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

Conditions

Interventions

DRUG

Adalimumab

Participants will receive subcutaneous (SC) injection of adalimumab

DRUG

ABP 501

Participants will receive SC injection of ABP 501

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2022-12-19
Completion
2022-12-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Estonia
  • Germany
  • Latvia
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT05073315 on ClinicalTrials.gov