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Plaque PsoriasisPhase 3PsOsimNCT02489227

Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

A Phase 3 study testing CHS-1420 and Adalimumab in people with Plaque Psoriasis, run by Coherus Oncology, Inc. at 99 sites in 16 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 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis. 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?
CHS-1420 and Adalimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
545 participants
Where
99 sitesin 16 countries
Study dates
Aug 2015to Mar 2017
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 of 0-5),
  • Body Surface Area (BSA) involved with PsO greater than or equal to 10%

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

99 sites in 16 countries.

99 sites in 16 countries

United States28 sites

  • James Henry Kopp, MD

    Anderson, South Carolina, 29621

  • Arlington Research Center, Inc.

    Arlington, Texas, 76011

  • PMG Research of Bristol, LLC

    Bristol, Tennessee, 37620

  • PMG Research of Raleigh, LLC

    Cary, North Carolina, 27518

  • Box Arthritis & Rheumetology of the Carolinas

    Charlotte, North Carolina, 28210

  • Michael Joseph Noss, MD

    Cincinnati, Ohio, 45249

  • Francisco A Kerdel, MD

    Coral Gables, Florida, 33134

  • Horizons Clinical Research Center, LLC.

    Denver, Colorado, 80220

  • Jack C Scott, MD

    Edina, Minnesota, 55435

  • Encino Research Center

    Encino, California, 91436

  • Dermatology and Skin Surgery Center, PC

    Exton, Pennsylvania, 19341

  • Center for Clinical Studies TMC/ Museum District Office

    Houston, Texas, 77004

  • Center for Clinical Studies

    Houston, Texas, 77065

  • Mark A Knautz, MD

    Marietta, Georgia, 30060

  • Central Sooner Research

    Norman, Oklahoma, 73031

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Sadra Sasha Jazayeri, MD

    Phoenix, Arizona, 85032

  • Linda Tripodis Murray, DO

    Pinellas Park, Florida, 33781

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Center for Dermatology and Laser Surgery

    Sacramento, California, 95819

  • Kenneth M Stein, MD

    Santa Rosa, California, 95405

  • Central Dermatology

    St Louis, Missouri, 63117

  • Craig L Leonardi, MD

    St Louis, Missouri, 63117

  • HealthCare Partners Medical Group Clinical Research Center

    Torrance, California, 90503

  • New England Research Associates LLC

    Trumbull, Connecticut, 06611

  • Grekin Skin Institute

    Warren, Michigan, 48088

  • Center for Clinical Studies

    Webster, Texas, 77598

  • ACRC-Dermatology

    West Palm Beach, Florida, 33406

Other trials in United States

Canada11 sites

  • Kingsway Clinical Research

    Etobicoke, Ontario, M8X 1Y9

  • Dermatology Center

    London, Ontario, N5X 2P1

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X2

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B 3Z7

  • Research by ICLS

    Oakville, Ontario, L6J 7W5

  • Skin Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • The Centre for Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • Research Toronto

    Toronto, Ontario, M4W 2N2

  • Research Toronto

    Toronto, Ontario, M5S 3B4

  • Probity Medical Research, Inc.

    Waterloo, Ontario, N2J 1C4

  • Windsor Clinical Research

    Windsor, Ontario, N8W 5L7

Other trials in Canada

Ukraine11 sites

  • Medical Center Private Enterprise "Dzerkalo"

    Dnipro, 49044

  • Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary

    Ivano-Frankivsk, 76018

  • Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2

    Kharkiv, 61038

  • Khmel'nytskyy Regional Dermatovenereological Dispensary

    Khmelnytskyi, 29009

  • National Medical University named after O.O.Bohomolets, Dept. of Dermatology and Venereology based on Oleksandrivska Clinical Hospital of Kyiv City, Dept. of Dermatology

    Kyiv, 01601

  • National Medical University named after Danyla Galytskoho, Dept. of Family Medicine and Dermatology, Venereology based on Dept. of Dermatovenereology of the clinical Hospital of Ukrainian State Border Guard Services

    Lviv, 79014

  • Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary

    Odesa, 65006

  • Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council

    Rivne, 33028

  • Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary

    Ternopil, 46006

  • Diagnostic and Treatment Dermatology and Gynecology Center

    Uzhhorod, 88000

  • Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council

    Zaporizhzhya, 69063

Other trials in Ukraine

Poland9 sites

  • Zdrowie Osteo-Medic s.c.

    Bialystok, 15-351

  • ClinicMed Badurski i wspólnicy Spółka Jawna

    Bialystok, 15-879

  • Centrum Badań Kliniccznych

    Gdansk, 80-456

  • Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"

    Krakow, 31-023

  • CenterMed Kraków Śp. z o. o.

    Krakow, 31-530

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

    Poznan, 60-702

  • Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"

    Torun, 87-100

  • Synexus Polska Śp. z o.o.

    Warsaw, 01-192

  • Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny

    Wroclaw, 51-124

Other trials in Poland

Russia7 sites

  • Altay State Medical University

    Barnaul, 651045

  • Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow

    Moscow, 109044

  • Moscow State University and Dentistry named after Evdokimov

    Moscow, 121614

  • Imc "Sogaz"

    Saint Petersburg, 191186

  • Olga Mikerina, MD

    Saint Petersburg, 195257

  • Alliance Biomedical Group

    Saint Petersburg, 94356

  • Clinic of Skin and Venereal Diseases of the Saratov State Medical University

    Saratov, 410028

Other trials in Russia

South Africa7 sites

  • Zubar Fazal Ahmed Vawda. MD

    Durban, 4091

  • Panorama Medical Centre, Room 136

    Panorama, Cape Town, 7500

  • The Park, Room 201, 2nd Floor

    Pinelands, 7405

  • Medicross Pretoria West 1st Floor

    Pretoria West, Pretoria, 0183

  • Synopsis Research cc

    Rondebosch, 7700

  • Synexus Heiderberg Clinical Research Centre

    Somerset West, 7130

  • Clinical Projects Research SA (PTY) Ltd.

    Worcester, 6850

Other trials in South Africa

Georgia5 sites

  • Aleksandre Aladshvili Clinic LLC

    Tbilisi, 0102

  • Tbilisi State Medical University Alexandre Aladashvili University Clinic

    Tbilisi, 0144

  • Scientific/Research National Center of Dermatology and Venereology

    Tbilisi, 0159

  • Health Institute LLC

    Tbilisi, 0160

  • Medical Center Clto Ltd

    Tbilisi, 0179

Other trials in Georgia

Israel4 sites

  • Department of Dermatology- Ha'Emek Medical Center

    Afula, 1834111

  • Meir Medical Center Dermatologic Clinic

    Kfar Saba, 4428164

  • Rabin Medical Center Department of Dermatology

    Petah Tikva, 49100

  • Department of Dermatology Phototherapy and Day Care Center

    Ramat Gan, 52621

Other trials in Israel

Chile3 sites

  • Clinica Dermacross SA

    Santiago, 7640881

  • Centro Intrnacional de Estudios Clinicos- CIEC

    Santiago, 8420383

  • Antonio Guglielmetti, MD

    Viña del Mar, 2520000

Other trials in Chile

Estonia3 sites

  • Tartu University Hospital, Dermatology Clinic

    Raja, Tartu, 50417

  • Innomedica OÜ

    Tallinn, 10117

  • North Estonian Medical Centre Foundation Skin and Sexual Diseases Center

    Tallinn, 13419

Other trials in Estonia

Italy3 sites

  • Department of Clinical and Molecular Sciences Dermatologic Clinic

    Ancona

  • Department of Internal Medicine and Medical Specialties Unit of Dermatology

    Reggio Emilia

  • Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore

    Rome

Other trials in Italy

Latvia3 sites

  • Janis Kisis, MD

    Jūrmala, LV-2008

  • Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre

    Riga, LV-1001

  • Kristine Berzina, MD, PhD

    Riga, LV-1046

Other trials in Latvia

Croatia2 sites

  • Naftalan, Special Hospital for Medical Rehabilitation

    Ivanić-Grad, 10310

  • Clinical Hospital Centre "Osijek"

    Osijek, 31000

Other trials in Croatia

Bulgaria1 site

  • Center for Dermatology and Venerology Diseases, EOOD, Sofia City

    Sofia, 1415

Other trials in Bulgaria

Moldova1 site

  • PMSI Institute of Cardiology

    Chisinau, MD2025

Other trials in Moldova

Slovakia1 site

  • DOST - Dermatovenerologicke oddelenie sanatorneho typu

    Svidník, 089 01

Other trials in Slovakia

About this study

Official title: A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.

Read the detailed description

This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO.

The study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.

Being tested
CHS-1420, Adalimumab
Keywords
PsO

What participants receive

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

Study groups in NCT02489227
Study groupRoleWhat they receive
Humira (adalimumab)Active comparatorAdalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be assigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. The assignments for treatment sequences (Treatment Period 1 and Treatment Period 2) were made randomly at the beginning of Treatment Period 1. At week 24 subjects will switch to CHS-1420 open label until study end.
Receives: Drug: CHS-1420; Drug: Adalimumab
CHS-1420ExperimentalCHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.
Receives: Drug: CHS-1420

What is being measured

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

  1. Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12

    The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.

    Measured: 12 weeks

Timeline

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

  1. First posted2 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completion6 May 2016
  4. Study completionMar 2017

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
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02489227
Sponsor's protocol ID
CHS-1420-02
Acronym
PsOsim
Status last verified
Mar 2020
First submitted
1 Jul 2015
Last updated
8 Apr 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CHS-1420 and Adalimumab in people with Plaque Psoriasis, run by Coherus Oncology, Inc. at 99 sites in 16 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 4 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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Canada, Ukraine, Poland, Russia and 11 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 18 Oct 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?

Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12 (time frame: 12 weeks). 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 NCT02489227.

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 8 Apr 2020.

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