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Plaque PsoriasisPhase 3NCT02134210

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)

A Phase 3 study testing Etanercept and CHS-0214 in people with Plaque Psoriasis, run by Coherus Oncology, Inc. at 100 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Etanercept and CHS-0214
Could I receive a placebo?
No, everyone receives an active treatment
How many people
521 participants
Where
100 sitesin 7 countries
Study dates
16 Jun 2014to 12 May 2016
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

  • Male or female adults
  • PsO diagnosis for 6 months
  • Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale or 0-5),
  • Body Surface Area (BSA) involved with PsO greater than or equal to 10%
  • Dermatology Life Quality Index (DQLI) greater than or equal to 10
  • Previously received phototherapy or systemic non-biologic therapy for PsO

Who cannot join

  • Forms of Psoriasis other than PsO
  • Drug induced Psoriasis
  • Positive QuantiFERON-tuberculosis (TB) Gold Test
  • Presence of significant comorbid conditions
  • Chemistry and hematology values outside protocol specified range
  • Major systemic infections

Trial locations and contacts

100 sites in 7 countries.

100 sites in 7 countries

United States50 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Dream Team Clinical Research

    Anaheim, California, 92801

  • Radiant Research - Anderson

    Anderson, South Carolina, 29621

  • Altman Dermatology Associates

    Arlington Heights, Illinois, 60005

  • Radiant Research - Atlanta

    Atlanta, Georgia, 30328

  • Private Practice - Jamie Weisman

    Atlanta, Georgia, 30342

  • PMG Research of Carey, LLC

    Cary, North Carolina, 27518

  • Dermatology and Laser Center of Charleston

    Charleston, South Carolina, 29414

  • DJL Clinical Research

    Charlotte, North Carolina, 28210

  • Radiant Research

    Cincinnati, Ohio, 45249

  • Mountain State Clinical Research

    Clarksburg, West Virginia, 26301

  • Neighborhood Medical Center

    Dallas, Texas, 75254

  • Horizons Clinical Research Center

    Denver, Colorado, 80220

  • Altoona Center for Clincal Research

    Duncansville, Pennsylvania, 16635

  • The Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • Radiant Research - Edina

    Edina, Minnesota, 55435

  • Private Practice

    Encino, California, 91436

  • Hamzavi Dermatology Clinical Research

    Fort Gratiot, Michigan, 48059

  • Rivergate Dermatology

    Goodlettsville, Tennessee, 37072

  • Radient Research - Greer

    Greer, South Carolina, 29650

  • Center for Clinical Studies

    Houston, Texas, 72004

  • Heights Dermatology and Aesthetic Center

    Houston, Texas, 77008

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Derm Research

    Louisville, Kentucky, 40217

  • Florida Academic Dermatology Center (U of Miami Hospital)

    Miami, Florida, 33136

  • The Savin Center

    New Haven, Connecticut, 06511

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Kansas City Dermatology

    Overland Park, Kansas, 66215

  • Arizona Research Center

    Phoenix, Arizona, 85020

  • Radiant Research - Pinellas Park

    Pinellas Park, Florida, 33781

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Skin Search of Rochester, Inc

    Rochester, New York, 14623

  • Progressive Clinical Research - San Antonio

    San Antonio, Texas, 78229

  • Skin Surgery Medical Group, Inc

    San Diego, California, 92117

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Radiant Research - Scottsdale

    Scottsdale, Arizona, 85251

  • Dermatology Associates, PLLC

    Seattle, Washington, 98101

  • Premier Clinical Research

    Spokane, Washington, 99204

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Central Dermatology

    St Louis, Missouri, 63117

  • DermResearch Center of New York

    Stony Brook, New York, 11790

  • Healthcare Partners Medical Group

    Torrance, California, 90503

  • New England Research Associates

    Trumbull, Connecticut, 06611

  • Grekin Skin Institute

    Warren, Michigan, 48093

  • Center for Clinical Studies

    Webster, Texas, 77598

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801

  • Atlantic Clinical Research Collaborative

    West Palm Beach, Florida, 33406

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland18 sites

  • NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik

    Bialystok, 15540

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J

    Bialystok, 15879

  • Centrum Badan Klinicznych PI-House Sp. Z o.o

    Gdansk, 80546

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81384

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40040

  • Specjalistyczny Osrodek ALL-MED

    Krakow, 31023

  • Krakowskie Centrum Medyczne

    Krakow, 31501

  • Center Med

    Krakow, 31530

  • Specjalistyczne Gabinety Lekarskie "Dermed

    Lodz, 90265

  • Centrum Medyczne SYNEXUS POZNAN

    Poznan, 60702

  • Centrum Medyczne Medyk

    Rzeszów, 35055

  • SANUS Szpital Specjalistyczny Sp. z o.o

    Stalowa Wola, 37450

  • EuroMedis Sp. z o.o.

    Szczecin, 70111

  • NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy z Przychodnia Specjalistyczna

    Torun, 87100

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, 01192

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02106

  • Synexus Polska sp. z o.o

    Wroclaw, 50088

  • Dermmedica Sp. z o.o

    Wroclaw, 51318

Other trials in Poland

Canada10 sites

  • CCA Medical Research Corporation

    Ajax, Ontario

  • E and D Woolner Professional Corporation

    Calgary, Alberta

  • Institute for Skin Advancement Inc

    Calgary, Alberta

  • Lynderm Research Inc

    Markham, Ontario

  • North Bay Dermatology Centre Inc

    North Bay, Ontario

  • Institute of Cosmetic and Laser Surgery

    Oakville, Ontario

  • SKiN Center for Dermatology

    Peterborough, Ontario

  • Private Practice

    Richmond Hill, Ontario

  • Research Toronto

    Toronto, Ontario

  • K. Papp Clinical Research Inc

    Waterloo, Ontario

Other trials in Canada

South Africa7 sites

  • Dr IC Louw

    Cape Town, 7500

  • Vincent Pallotti Hospital

    Pinelands, Cape Town, 7405

  • Jongaie Research

    Pretoria West, Pretoria, 0183

  • Synopsis Research

    Rondebosch, Cape Town, 7700

  • Helderberg Clinical Trial Centre

    Somerset West, Western Cape, 7130

  • Winelands Rheumatology Centre

    Stellenbosch

  • Clinical Projects Research

    Worcester, 6850

Other trials in South Africa

Germany6 sites

  • MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow

    Berlin, 13055

  • Klinische Forschung Dresden GmbH

    Dresden, 01069

  • Hautklinik Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Johann Wolfgang Hospital - Goethe University

    Frankfurt, 60590

  • Dermatologikum Hamburg

    Hamburg, 20354

  • University Hospital Schleswig-Holstein - Campus Luebeck

    Lübeck, 23538

Other trials in Germany

Australia5 sites

  • Sinclair Dermatology

    East Melbourne, Victoria, 3002

  • North Eastern Health Specialists

    Hectorville, South Australia, 5073

  • Dr S P Shumack (St George Dermatology and Skin Cancer Center)

    Kogarah, New South Wales, 2217

  • Woden Dermatology Pty

    Phillip, Australian Capital Territory, 2606

  • Dr S P Shumack (Central Sydney Dermatology)

    Sydney, New South Wales, 2000

Other trials in Australia

Israel4 sites

  • Haemek Medical Center

    Afula, 18101

  • Rambam Health Care Campus

    Haifa, 31096

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Chronic Plaque Psoriasis (RaPsOdy)

This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones).

Read the detailed description

Pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 75% improvement from baseline according to the Psoriasis Area and Severity Index (PASI-75). Comparing CHS-0214 to Enbrel for efficacy and safety at a dosage of 50mg subcutaneous (Sc) twice weekly.

Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.

Being tested
Etanercept, CHS-0214
Keywords
PsO

What participants receive

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

  • EtanerceptDrug

    Also called Enbrel, European Enbrel

    Head-to-head comparison

  • CHS-0214Drug

Study groups in NCT02134210
Study groupRoleWhat they receive
Enbrel (etanercept)Active comparatorEnbrel 50mg twice weekly times 12 weeks
Receives: Drug: Etanercept
CHS-0214ExperimentalCHS-0214 50mg twice weekly times 12 weeks
Receives: Drug: CHS-0214

What is being measured

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

  1. Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12

    The Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis.

    Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US.

    Measured: 12-weeks

  2. Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks

    Mean percent changed in PASI from baseline (last non-missing value prior to first dose) at Week 12. This was the primary endpoint supporting the Marketing Authorization Application in the EU.

    Measured: 12 Weeks

Secondary outcomes (11)

  1. Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline

    Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48

    Measured: Weeks 4, 8, 12, 24, 36, and 48

  2. Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)

    The proportion of subjects who achieved PASI-75 (75% Improvement in Psoriasis Area and Severity Index) from baseline at Weeks 4, 8, 12, 24, 36, and 48.

    Measured: Weeks 4, 8, 12, 24, 36, and 48

  3. Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)

    The proportion of subjects who achieved a 50% improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% improvement in PASI (PASI-90) response rates from baseline at Weeks 4, 8, 12, 24, 36, and 48

    Measured: Weeks 4, 8, 12, 24, 36, and 48

  4. Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5

    Change in PSGA (Physician's Static Global Assessment) of disease activity on a scale of 0 to 5 from baseline to Weeks 4, 8, 12, 24, 36, and 48.

    Minimum Value: 0 Maximum Value: 5

    The PSGA of PsO (Psoriasis) was assessed on a scale of 0 to 5, with 0 indicating no PsO (clear of disease),1 (almost clear), and 2 or higher scores indicating more severe disease. Subjects with a clear (0) or almost clear (1) evaluation were considered PSGA responders.

    Measured: 4, 8, 12, 24, 36, and 48

  5. The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1

    The proportion of subjects with a change in a PSGA (Physician's Static Global Assessment) score = 0 to 1, demonstrating clear or almost clear skin at Weeks 4, 8, 12, 24, 36, and 48;

    Minimum: 0 Maximum: 1 Subjects with a clear(0) or almost clear(1) evaluation were considered PSGA responders.

    Measured: Weeks 4, 8, 12, 24, 36, and 48

  6. Change in Subject's Global Assessment (SGA) of PsO

    Change in Subject's Global Assessment (SGA) of PsO from baseline to Weeks 4, 8, 12, 24, 36, and 48. The SGA of PsO was assessed using VAS (visual analog scale in the unit of millimeters) , ranging from 0 (good) to 100 (severe). The SGA was assessed at randomization (Week 0/Day 0) and Weeks 4, 8, 12, 24, 36, and 48, as well as at the Follow-up Visit, if applicable. The change in SGA is the value at baseline minus sum of values at weeks 4, 8, 12, 24, 36, and 48. Since the change in SGA is measured from baseline, a negative value indicates a decrease in overall SGA and better overall assessment of PsO.

    Measured: Weeks 4, 8, 12, 24, 36, and 48

  7. Change in DLQI (Dermatology Life Quality Index)

    Change in DLQI (Dermatology Life Quality Index) from baseline to Weeks 12, 24, and 48

    The DLQI is a 10-question validated questionnaire that was performed at screening, randomization (Week 0/Day 0), and Weeks 12, 24, and 48. It was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired.

    Measured: Weeks 12, 24, and 48

  8. Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)

    Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) from baseline to Weeks 12, 24, and 48

    The EQ-5D was performed at randomization (Week 0/Day 0), and Weeks 12, 24, and 48. The EQ-5D is a generic (non-disease specific), preference-based health-related quality of life measure based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).

    Measured: Weeks 12, 24, and 48

  9. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)

    HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.

    Measured: Weeks 12, 24, and 48

  10. Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)

    Change in highly sensitive C-reactive protein (hs-CRP; mg/L) from baseline to Weeks 12, 24, and 48 for subjects with PsA (Psoriatic arthritis) only.

    Highly sensitive C-reactive protein For subjects with PsA, change in hs-CRP from baseline to Weeks 12, 24, and 48 was assessed.

    Measured: Weeks 12, 24, and 48

  11. The Proportion of Subjects With a Durability of Response at Week 48

    The proportion of subjects with a durability of response during Part 2. Durability of response was defined as the maintenance of the PASI-50 or greater at Weeks 24, 36, and 48 when compared to baseline (Week 0).

    Measured: Weeks 24, 36, and 48 when compared to baseline (Week 0).

Timeline

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

  1. First posted9 May 2014 (estimated)
  2. Study start16 Jun 2014
  3. Primary completion27 Jul 2015
  4. Study completion12 May 2016

Resources

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
521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02134210
Sponsor's protocol ID
CHS-0214-04
Status last verified
Jun 2019
First submitted
7 May 2014
Last updated
28 Jun 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etanercept and CHS-0214 in people with Plaque Psoriasis, run by Coherus Oncology, Inc. at 100 sites in 7 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 6 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 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Poland, Canada, South Africa, Germany and 2 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 13 May 2019). 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?

Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 (time frame: 12-weeks). The study lists 2 primary outcomes in all. 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 NCT02134210.

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 28 Jun 2019.

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