A multicenter study to evaluate safety and efficacy of GP2017 comparing to Humira in patients with long term plaque-type psoriasis.

A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar adalimumab (GP2017) and HumiraÂ® in patients with moderate to severe chronic plaque-type psoriasis. - ADACESS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/06/005941

Enrollment

448

Registered

2015-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Plaque-type Psoriasis

Interventions

Intervention1: GP2017 Adalimumab: 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 4

Eligibility

Inclusion criteria

Inclusion criteria: > > Men or women at least 18 years of age at time of screening > > Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization > > Moderate to severe psoriasis as defined at baseline by: > > PASI score of 12 or greater > > InvestigatorÂ´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and, > > Body Surface Area affected by plaque-type psoriasis of 10% or greater > > Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.

Exclusion criteria

Exclusion criteria: 1. Forms of psoriasis other than chronic plaque-type 2. Drug-induced psoriasis 3. Ongoing use of prohibited psoriasis treatments 4. Previous exposure to adalimumab 5. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept.

Design outcomes

Secondary

Measure	Time frame
1. PASI response rates [Designated as safety issue: No] PASI 50, 75, 90 and 100 will be assessed. Timepoint: Time Frame: Weeks 1,3,5,7,9,11,13, 15,16,17;2. Change from baseline in IGA [Designated as safety issue: No] Timepoint: Time Frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 16 and 17.;3. Patient health related quality of life (HRQoL) [Designated as safety issue: No] Timepoint: Time Frame: Week 11 and 16.	—

Measure

Time frame

1. PASI response rates [Designated as safety issue: No] PASI 50, 75, 90 and 100 will be assessed. Timepoint: Time Frame: Weeks 1,3,5,7,9,11,13, 15,16,17;2. Change from baseline in IGA [Designated as safety issue: No] Timepoint: Time Frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 16 and 17.;3. Patient health related quality of life (HRQoL) [Designated as safety issue: No] Timepoint: Time Frame: Week 11 and 16.

—

Primary

Measure	Time frame
The primary outcome measure is the PASI 75 response rate. [Designated as safety issue: No]Timepoint: The primary outcome measure is the PASI 75 response rate. [Designated as safety issue: No]	—

Countries

Bulgaria, France, Germany, India, Russian Federation, Spain, United States of America

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026