Chronic Stable Plaque PsoriasisPhase 3EGALITYNCT01891864

Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel

A Phase 3 study testing GP2015 Etanercept and Enbrel in people with Chronic Stable Plaque Psoriasis, run by Sandoz at 74 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 response rate at Week 12. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Stable Plaque Psoriasis
What is being tested?: GP2015 Etanercept and Enbrel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 531 participants
Where: 74 sitesin 12 countries
Study dates: Jun 2013to Mar 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women at least 18 years of age at time of screening
Chronic plaque-type psoriasis diagnosed for at least 6 months before baseline
Moderate to severe psoriasis as defined at baseline by:
PASI score of 10 or greater and,
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.

Who cannot join

Forms of psoriasis other than chronic plaque-type
Drug-induced psoriasis
Ongoing use of prohibited treatments
Previous exposure to etanercept
Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept
Other In-/Exclusion criteria may apply

Trial locations and contacts

74 sites in 12 countries.

Country

City, postcode or hospital

74 sites in 12 countries

Poland14 sites

Sandoz Investigational Site
Gdansk
Sandoz Investigational Site
Gdynia
Sandoz Investigational Site
Katowice
Sandoz Investigational Site 1
Krakow
Sandoz Investigational Site 2
Krakow
Sandoz Investigational Site 1
Lodz
Sandoz Investigational Site 2
Lodz
Sandoz Investigational Site 3
Lodz
Sandoz Investigational Site 4
Lodz
Sandoz Investigational Site
Poznan
Sandoz Investigational Site
Rzeszów
Sandoz Investigational Site
Warsaw
Sandoz Investigational Site
Wroclaw
Sandoz Investigational Site
Zgierz

Other trials in Poland

Romania9 sites

Sandoz Investigational Site
Brasov
Sandoz Investigational Site 1
Bucharest
Sandoz Investigational Site 2
Bucharest
Sandoz Investigational Site 3
Bucharest
Sandoz Investigational Site
Cluj-Napoca
Sandoz Investigational Site 1
Iași
Sandoz Investigational Site 2
Iași
Sandoz Investigational Site
Târgu Mureş
Sandoz Investigational Site
Timișoara

Other trials in Romania

Slovakia8 sites

Sandoz Investigational Site
Banská Bystrica
Sandoz Investigational Site
Bojnice
Sandoz Investigational Site 1
Bratislava
Sandoz Investigational Site 2
Bratislava
Sandoz Investigational Site
Košice
Sandoz Investigational Site
Kosice-Saka
Sandoz Investigational Site
Nitra
Sandoz Investigational Site
Svidník

Other trials in Slovakia

Ukraine8 sites

Sandoz Investigational Site
Dnipropetrovsk
Sandoz Investigational Site
Donetsk
Sandoz Investigational Site
Kharkiv
Sandoz Investigational Site
Kyiv
Sandoz Investigational Site
Luhansk
Sandoz Investigational Site
Rivne
Sandoz Investigational Site
Simferopol
Sandoz investigational Site
Zaporizhzhya

Other trials in Ukraine

Germany7 sites

Sandoz Investigational Site 1
Berlin
Sandoz Investigational Site 2
Berlin
Sandoz Investigational Site 1
Dresden
Sandoz Investigational Site 2
Dresden
Sandoz Investigational Site
Kiel
Sandoz Investigational Site
Lübeck
Sandoz Investigational Site
Munich

Other trials in Germany

Bulgaria5 sites

Sandoz Investigational Site
Pleven
Sandoz Investigational Site
Plovdiv
Sandoz Investigational Site 1
Sofia
Sandoz Investigational Site 2
Sofia
Sandoz Investigational Site 3
Sofia

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Estonia5 sites

Sandoz Investigational Site 1
Tallinn
Sandoz Investigational Site 2
Tallinn
Sandoz Investigational Site 3
Tallinn
Sandoz Investigational Site 1
Tartu
Sandoz Investigational Site 2
Tartu

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United Kingdom5 sites

Sandoz Investigational Site
Dundee
Sandoz Investigational Site
Leeds
Sandoz Investigational Site
London
Sandoz Investigational Site
Newcastle upon Tyne
Sandoz Investigational Site
Salford

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Hungary4 sites

Sandoz Investigational Site
Budapest
Sandoz Investigational Site
Debrecen
Sandoz Investigational Site
Gyula
Sandoz Investigational Site
Szolnok

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South Africa4 sites

Sandoz Investigational Site
Bloemfontein
Sandoz Investigational Site
Krugersdorp
Sandoz Investigational Site 1
Pretoria
Sandoz Investigational Site
Worcester

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Czechia3 sites

Sandoz Investigational Site
Olomouc
Sandoz Investigational Site
Prague
Sandoz Investigational Site
Ústí nad Labem

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Russia2 sites

Sandoz Investigational Site
Saint Petersburg
Sandoz Investigational Site
Smolensk

Other trials in Russia

About this study

Official title: A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Etanercept (GP2015) and Enbrel® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Read the detailed description

The purpose of this confirmatory safety and efficacy study (GP15-302) was to demonstrate equivalence in efficacy and similarity in safety and immunogenicity of GP2015 and Enbrel (EU-authorized) in patients with moderate to severe chronic plaque-type psoriasis and to evaluate the effects of repeated switching between GP2015 and Enbrel on efficacy, overall safety, and immunogenicity. Since only EU-authorized Enbrel was utilized in this study, the use of the term "Enbrel" throughout this report describes EU-authorized Enbrel only.

Conditions: Chronic Stable Plaque Psoriasis
Being tested: GP2015 Etanercept, Enbrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GP2015 EtanerceptDrug
Also called GP2015, Etanercept
Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.
EnbrelDrug
Also called Etanercept
Enbrel is used as reference product to GP2015.

Study groups in NCT01891864
Study group	Role	What they receive
GP2015 Etanercept	Experimental	Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter Receives: Drug: GP2015 Etanercept
Enbrel ® Etanercept	Active comparator	Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter Receives: Drug: Enbrel

What is being measured

The primary outcome is the main question the study is designed to answer.

PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Measured: Week 12

Secondary outcomes (4)

Percent Change From Baseline in PASI Score up to Week 12
The key secondary efficacy endpoint was the % change from baseline in PASI score up to Week 12. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. Two approaches (longitudinal approach applying a Mixed Model Repeated Measures and Averaged Treatment Effect approach applying an ANCOVA model) were employed in order to calculate 2-sided 95% confidence intervals (CI) for the difference between the treatment groups.
Measured: 12 weeks
PASI 50, 75 and 90 Response Rates
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, and PASI 90 responses at Week 12. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders .PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders .
Measured: Week12
Injection Site Reactions
Percentage of patients with injection site reactions up to Week 52
Measured: Week52
Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept
Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Mar 2015

First posted3 Jul 2013 (estimated)
Study startJun 2013
Primary completionJun 2014
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Stable Plaque PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 531 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01891864
Sponsor's protocol ID: GP15-302
Acronym: EGALITY
Status last verified: Feb 2017
First submitted: 24 Jun 2013
Last updated: 27 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Thaci D, Gerdes S, Schulze-Koops H, Allanore Y, Kavanaugh A, Both C, Gattu S, Hachaichi S, Matucci-Cerinic M. Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA). Drugs R D. 2025 Jun;25(2):107-115. doi: 10.1007/s40268-025-00507-8. Epub 2025 Apr 25.
PubMed 40279006

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Etanercept (GP2015) and Enbrel® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
ClinicalTrials.gov ID: NCT01891864
Acronym / sponsor ID: EGALITY / GP15-302
Conditions: Chronic Stable Plaque Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 531 participants (actual)
Lead sponsor: SandozIndustry (pharma, biotech, devices)
Collaborators: Hexal AG
Study start: Jun 2013
Primary completion: Jun 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 3 Jul 2013 (estimated)
Results: Posted 27 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GP2015 Etanercept	Experimental	Drug: GP2015 EtanerceptSolution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
Enbrel ® Etanercept	Active comparator	Drug: EnbrelSolution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Men or women at least 18 years of age at time of screening
Chronic plaque-type psoriasis diagnosed for at least 6 months before baseline
Moderate to severe psoriasis as defined at baseline by:
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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GP2015 EtanerceptAlso: GP2015, EtanerceptSandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.	Drug	GP2015 Etanercept
EnbrelAlso: EtanerceptEnbrel is used as reference product to GP2015.	Drug	Enbrel ® Etanercept

Primary outcome

PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
Time frame: Week 12
The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.

4 secondary outcomes

Percent Change From Baseline in PASI Score up to Week 12
Time frame: 12 weeks
PASI 50, 75 and 90 Response Rates
Time frame: Week12
Injection Site Reactions
Time frame: Week52
Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept
Time frame: Week 52

Results and safety

Results posted to the registry on 27 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GP2015 Etanercept	264	256
Enbrel ® Etanercept	267	255
GP2015 Etanercept Continued	0	0
Enbrel ® Etanercept Continued	0	0
GP2015 Etanercept Switched	0	0
Enbrel ® Etanercept Switched	0	0

Primary outcome: PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept

Time frame: Week 12. Number. Unit: % of patients achieving PASI75 response

Measure	GP2015 Etanercept n = 239	Enbrel ® Etanercept n = 241
Value	73.4	75.7

GP2015 Etanercept vs Enbrel ® Etanercept: Risk Difference (RD): -2.3 (95% CI -9.85 to 5.3)

Population analysed: The analysis of the primary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are reported until the end of the study (week 52).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GP2015 Etanercept Continued	7 of 164 (4.3%)	97 of 164 (59.1%)	Not reported
Enbrel ® Etanercept Switched	6 of 96 (6.3%)	57 of 96 (59.4%)	Not reported
GP2015 Etanercept Switched	6 of 100 (6%)	60 of 100 (60%)	Not reported
Enbrel ® Etanercept Continued	7 of 171 (4.1%)	94 of 171 (55%)	Not reported

Limitations and caveats (from the sponsor): None reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40279006Thaci D, Gerdes S, Schulze-Koops H, Allanore Y, Kavanaugh A, Both C, Gattu S, Hachaichi S, Matucci-Cerinic M. Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA). Drugs R D. 2025 Jun;25(2):107-115. doi: 10.1007/s40268-025-00507-8. Epub 2025 Apr 25.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sascha Gerdes, MD principal investigator

Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig Holstein, Kiel, Germany

74 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GP2015 Etanercept and Enbrel in people with Chronic Stable Plaque Psoriasis, run by Sandoz at 74 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Poland, Romania, Slovakia, Ukraine, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01891864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.