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PsoriasisPhase 3NAVIGATENCT02203032

A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

A Phase 3 study testing Ustekinumab and Guselkumab in people with Psoriasis, run by Janssen Research & Development, LLC at 85 sites in 10 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 evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Psoriasis
What is being tested?
Ustekinumab and Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
872 participants
Where
85 sitesin 10 countries
Study dates
7 Oct 2014to 24 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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug
  • Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
  • Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
  • Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
  • Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)

Who cannot join

  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Has unstable cardiovascular disease, defined as a recent clinical deterioration (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
  • Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
  • Has previously received guselkumab or ustekinumab

Trial locations and contacts

85 sites in 10 countries.

85 sites in 10 countries

United States29 sites

  • Study site

    Alpharetta, Georgia

  • Study site

    Arlington, Texas

  • Study site

    Arlington Heights, Illinois

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bakersfield, California

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Buffalo, New York

  • Study site

    Chicago, Illinois

  • Study site

    Coral Gables, Florida

  • Study site

    Dallas, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Johnston, Rhode Island

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Ocala, Florida

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plainfield, Indiana

  • Study site

    Portland, Oregon

  • Study site

    San Antonio, Texas

  • Study site

    Santa Monica, California

  • Study site

    Skokie, Illinois

  • Study site

    Spokane, Washington

  • Study site

    Troy, Michigan

  • Study site

    Webster, Texas

Other trials in United States

Poland11 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Gdansk

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Olsztyn

  • Study site

    Poznan

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Germany10 sites

  • Study site

    Berlin

  • Study site

    Bonn

  • Study site

    Essen

  • Study site

    Gera

  • Study site

    Hamburg

  • Study site

    Leipzig

  • Study site

    Lübeck

  • Study site

    Mahlow

  • Study site

    Münster

  • Study site

    Witten

Other trials in Germany

Canada8 sites

  • Study site

    Ajax, Ontario

  • Study site

    Halifax, Nova Scotia

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Richmond Hill, Ontario

  • Study site

    Surrey, British Columbia

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Russia7 sites

  • Study site

    Chelyabinsk

  • Study site

    Krasnodar

  • Study site

    Lipetsk

  • Study site

    Saint Petersburg

  • Study site

    Stavropol

  • Study site

    Ufa

  • Study site

    Yekaterinburg

Other trials in Russia

Spain5 sites

  • Study site

    A Coruña

  • Study site

    Alcorcón

  • Study site

    Alicante

  • Study site

    Barcelona

  • Study site

    Madrid

Other trials in Spain

Australia4 sites

  • Study site

    Fremantle

  • Study site

    Victoria Park

  • Study site

    Woden

  • Study site

    Woolloongabba

Other trials in Australia

Taiwan4 sites

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

United Kingdom4 sites

  • Study site

    Dudley

  • Study site

    Dundee

  • Study site

    London

  • Study site

    Salford

Other trials in United Kingdom

South Korea3 sites

  • Study site

    Anyang

  • Study site

    Incheon

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.

Read the detailed description

This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.

Conditions
Psoriasis
Being tested
Ustekinumab, Guselkumab, Placebo for ustekinumab, Placebo for guselkumab
Keywords
Psoriasis, Plaque-type psoriasis, Guselkumab, Ustekinumab, CNTO 1959, Monoclonal antibody
Medical subject headings
Psoriasis

What participants receive

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

  • UstekinumabDrug

    45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.

  • GuselkumabDrug

    100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.

  • Placebo for ustekinumabDrug

    Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.

  • Placebo for guselkumabDrug

    Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.

Study groups in NCT02203032
Study groupRoleWhat they receive
Open-label ustekinumabExperimentalNot described
Receives: Drug: Ustekinumab
Double-blind guselkumabExperimentalNot described
Receives: Drug: Guselkumab; Drug: Placebo for ustekinumab
Double-blind ustekinumabExperimentalNot described
Receives: Drug: Ustekinumab; Drug: Placebo for guselkumab

What is being measured

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

  1. Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40

    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

    Measured: Week 28 through Week 40

Secondary outcomes (3)

  1. Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40

    The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

    Measured: Week 28 through Week 40

  2. Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40

    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

    Measured: Week 28 through Week 40

  3. Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28

    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

    Measured: Week 28

Timeline

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

  1. First posted29 Jul 2014 (estimated)
  2. Study start7 Oct 2014
  3. Primary completion25 Dec 2015
  4. Study completion24 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
872 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02203032
Sponsor's protocol ID
CR104918
Other IDs
CNTO1959PSO3003, 2014-000721-20, 2014
Acronym
NAVIGATE
Status last verified
Aug 2017
First submitted
25 Jul 2014
Last updated
12 Sep 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.

    PubMed 37906417

  • Campbell K, Li K, Yang F, Branigan P, Elloso MM, Benson J, Orlovsky Y, Chen Y, Garcet S, Krueger JG. Guselkumab More Effectively Neutralizes Psoriasis-Associated Histologic, Transcriptomic, and Clinical Measures than Ustekinumab. Immunohorizons. 2023 Apr 1;7(4):273-285. doi: 10.4049/immunohorizons.2300003.

    PubMed 37071038

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab and Guselkumab in people with Psoriasis, run by Janssen Research & Development, LLC at 85 sites in 10 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 5 inclusion and 4 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Poland, Germany, Canada, Russia and 5 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 17 Jul 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?

Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40 (time frame: Week 28 through Week 40). 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 NCT02203032, which also lists 2 linked publications.

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 12 Sep 2017.

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