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

Phase 3

• Conditions: Health Condition 1: null- Chronic Plaque-type Psoriasis

• Registration Number: CTRI/2015/06/005941
• Lead Sponsor: ovartis Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 448

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

> > Investigator´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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the PASI 75 response rate. <br/ ><br> <br/ ><br>[Designated as safety issue: No]Timepoint: The primary outcome measure is the PASI 75 response rate. <br/ ><br> <br/ ><br>[Designated as safety issue: No]

Secondary Outcome Measures

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