Skip to main content
OpenTrials
Completed

NCT Number: NCT02016105

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plaque Type Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UMHAT Dr. Georgi Stranski, EAD, Pleven, Bulgaria

Loading trial locations.

About this study

The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.

The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Forms of psoriasis other than chronic plaque-type
  • Drug-induced psoriasis
  • Ongoing use of prohibited psoriasis treatments
  • Previous exposure to adalimumab
  • Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab

Other In-/Exclusion criteria may apply

Treatment and study plan

GP2017 Adalimumab

Drug

Humira ® Adalimumab

Drug

Primary outcomes

  1. PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab

    Time frame: At Week 16 only

    The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.

Secondary outcomes

  1. Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)

    Time frame: Baseline to Week 16

    The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.

  2. Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)

    Time frame: Baseline to Week 16

    The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).

  3. PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates

    Time frame: At Week 17 only

    Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)

  4. PASI 50, PASI75, PASI 90 and PASI100 Response Rates

    Time frame: At Week 35 only

    Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)

  5. PASI 50, PASI75, PASI 90 and PASI100 Response Rates

    Time frame: At Week 51 only

    Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)

  6. IGA Response Rate

    Time frame: At Week 17 only

    Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 17.

  7. IGA Response Rate

    Time frame: At Week 35 only

    Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51

  8. IGA Response Rate

    Time frame: At Week 51 only

    Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51

  9. DLQI

    Time frame: At Week 17 only

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

  10. DLQI

    Time frame: At Week 35 only

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

  11. DLQI

    Time frame: At Week 51 only

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

  12. ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17

    Time frame: At Week 17 only

    Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17.

    Patients with ADA positive results at baseline were excluded from subsequent results.

  13. ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51

    Time frame: At Week 51 only

    Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51.

    Patients with ADA positive results at baseline were excluded from subsequent results.

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

  • Hexal AG

Registry information

Official study title

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Acronym: ADACCESS

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 19, 2013
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.