Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
(ADACCESS Trial)

Recruiting in Palo Alto (17 mi)

+78 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sandoz

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Research Team

Eligibility Criteria

Inclusion Criteria

Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and

Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization

PASI score of 12 or greater

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Treatment Details

Interventions

GP2017 Adalimumab (Monoclonal Antibodies)
Humira ® Adalimumab (Monoclonal Antibodies)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: GP2017 AdalimumabExperimental Treatment1 Intervention

Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

Group II: Humira ® AdalimumabActive Control1 Intervention

Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.