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Pustular PsoriasisPhase 3NCT02343744

An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

A Phase 3 study testing Guselkumab in people with Pustular Psoriasis, run by Janssen Pharmaceutical K.K. at 20 sites in Japan.

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 examine descriptively the efficacy of CNTO 1959 in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Pustular Psoriasis
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
20 sitesJapan
Study dates
19 Jan 2015to 2 Nov 2018
Phase
Phase 3
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. A diagnosis of GPP must be classified on the basis of the criteria for diagnosis of GPP by Japanese Dermatological Association (JDA)
  • Have a history of plaque-type psoriasis if subjects have a diagnosis of EP
  • Have an involved body surface area (BSA) of lesion greater than or equal to (>=) 80 percent (%) at baseline if subjects have a diagnosis of EP.
  • Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
  • Before the first administration of study drug, a woman must be either not of childbearing potential or of childbearing potential and practicing a highly effective methods of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies

Who cannot join

  • Has a total score of JDA severity index for GPP >=14 at baseline if subjects have a diagnosis of GPP
  • Has a differential diagnosis of the erythroderma (exmaple (eg), erythroderma caused by lymphoma or drug eruption) other than EP.
  • Has refused hospitalization though the investigator needed hospitalization
  • Has body mass index (BMI) less than (<) 18 kilogram per square meters (kg/m^2) or meets the following modified criteria for cachexia.
  • Has a BMI < 20 kg/m^2 and has lost more than 5% of their body weight in the previous months, and 4 out of the following are present: a) decreased muscle strength b) fatigue or reduced physical activity c) anorexia d) low muscle mass e) CRP greater than (>) 7 mg/L 6) hemoglobin (Hb) <12 gram per deciliters (g/dL) f) serum albumin < 3.0 g/dL
  • Has Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Grade 2 or higher heart failure or CTCAE v.4 Grade 3 or higher kidney failure

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Japan20 sites

  • Study site

    Asahikawa

  • Study site

    Fukuoka

  • Study site

    Gifu

  • Study site

    Izumo

  • Study site

    Kawasaki

  • Study site

    Kita-Gun

  • Study site

    Kochi

  • Study site

    Kurume

  • Study site

    Matsumoto

  • Study site

    Miyagi

  • Study site

    Morioka

  • Study site

    Nagoya

  • Study site

    Sapporo

  • Study site

    Shimotsuke

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Tsu

  • Study site

    Tsukuba

  • Study site

    Ube

  • Study site

    Yokosuka

Other trials in Japan

About this study

Official title: A Phase 3, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of CNTO1959 (Guselkumab) in the Treatment of Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

The purpose of this study is to examine descriptively the efficacy of CNTO 1959 in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Read the detailed description

This is a phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), open-label study evaluating the efficacy and safety of CNTO1959 (Guselkumab) in the treatment of participants with GPP or EP. Participants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 up to Week 52 participants who will be defined "Very much improved" or "Much improved" in Clinical Global Impression (CGI) will continue to receive guselkumab 50 mg every 8 weeks from Week 20 to the study end (Week 52). At each visit timing from Week 20, participants who will be defined "No change" or "Worsened" will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until Week 52. Participants who are "Minimally improved" will also receive guselkumab 100 mg only if investigator considers it necessary. Participants will primarily be assessed for the treatment success. Participants' safety will be monitored throughout the study.

Being tested
Guselkumab
Keywords
Generalized Pustular Psoriasis, Erythrodermic Psoriasis, Guselkumab, CNTO1959
Medical subject headings
Psoriasis

What participants receive

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

  • GuselkumabDrug

    Also called CNTO 1959

    Participants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 through the study end (Week 52) participants who are defined "Very much improved" or "Much improved" in Clinical Global Impression (CGI) will continue to receive guselkumab 50 mg every 8 weeks from Week 20 to the study end (Week 52). At each visit timing from Week 20, participants who are defined "No change" or "Worsened" in CGI will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until the study end (Week 52). Participants who are defined "Minimally improved" in CGI will also receive guselkumab 100 mg only if the investigator considers that it is necessary.

Study groups in NCT02343744
Study groupRoleWhat they receive
GuselkumabExperimentalParticipants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 through the study end (Week 52) participants who are defined "Very much improved" or "Much improved" in Clinical Global Impression (CGI) will continue to receive guselkumab 50 mg every 8 weeks from Week 20 to the study end (Week 52). At each visit timing from Week 20, participants who are defined "No change" or "Worsened" in CGI will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until the study end (Week 52). Participants who are defined "Minimally improved" in CGI will also receive guselkumab 100 mg only if the investigator considers that it is necessary.
Receives: Drug: Guselkumab

What is being measured

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

  1. Percentage of Participants with Treatment Success at Week16

    Treatment success is defined as "Very much improved", "Much improved" or "Minimally improved" in Clinical Global Impression (CGI) scale. The CGI scale is a brief clinician-rated instrument which has five categories (Very much improved (1), Much improved (2), Minimally improved (3), No change (4), Worsened (5).

    Measured: Week 16

Secondary outcomes (14)

  1. Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 and Over Time

    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score less than (<) 6 indicates that psoriasis has small or no effect at all on participant's life. In addition to evaluating overall quality of life (QOL) can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.

    Measured: Baseline, Week 16, 28, 36, 48 and 52

  2. Percentage of Participants with Treatment Success Over Time

    Treatment success is defined as "Very much improved", "Much improved" or "Minimally improved" in Clinical Global Impression (CGI) scale. The CGI scale is a brief clinician-rated instrument which has five categories (Very much improved (1), Much improved (2), Minimally improved (3), No change (4), Worsened (5).

    Measured: Baseline and Every 4 weeks up to Week 52

  3. Percentage of Participants With Investigator's global assessment (IGA) score of 0 or 1 at Week 16 and over time

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

    Measured: Week 16, 28, 36, 48 and 52

  4. Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 and over time

    The Psoriasis Area and Severity Index (PASI) is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a total numeric score that can range from 0 to 72.

    Measured: Week 16, 28, 36, 48 and 52

  5. Change From Baseline in Total and Component Japanese Dermatological Association (JDA) Severity Index for Generalized Pustular Psoriasis (GPP) Over Time

    Japanese Dermatological Association (JDA) severity index for GPP consists of area of etythema with pustules, area of erythema (total), area of edema, fever, white blood cells (WBC), high sensitivity C-reactive protein (hsCRP) and serum albumin. The total score of JDA severity index for GPP is assigned a score of 0-17 (0=best, 17=worst).

    Measured: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52

  6. Change From Baseline in Components of the JDA Severity Index for GPP Over Time

    Area of erythema with pustules, area of erythema (total), area of edema are rated as 0 to 3. Fever, WBC, hsCRP and serum albumin are rated as 0 to 2.

    Measured: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52

  7. Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP Over Time

    Area of erythema with pustules, area of erythema (total), area of edema are rated as 0 to 3. Fever, WBC, hsCRP and serum albumin are rated as 0 to 2.

    Measured: Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52

  8. Change From Baseline in Body Surface Area (BSA) of Involvement of Lesion for Erythrodermic Psoriasis (EP) Over Time

    Calculation of BSA involvement in dermatological lesion is used to measure disease severity and treatment responses for participants with EP.

    Measured: Baseline, Week 1, 2, 4, 6, 8, 16, 28, 36, 48 and 52

  9. Percentage of Participants with DLQI Score of 0 or 1 Over Time in Participants With Baseline DLQI More Than 1

    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score less than (<) 6 indicates that psoriasis has small or no effect at all on participant's life. In addition to evaluating overall quality of life (QOL) can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.

    Measured: Baseline, Week 8, 16, 28, 36, 48 and 52

  10. Percentage of Participants With a Reduction of 5 or More Points in DLQI Score Over Time

    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score less than (<) 6 indicates that psoriasis has small or no effect at all on participant's life. In addition to evaluating overall quality of life (QOL) can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.

    Measured: Baseline, Week 8, 16, 28, 36, 48 and 52

  11. Change From Baseline in Physical and Mental Component Summary Scores of SF-36 Over Time

    The Short Form Health Survey (SF-36) is a generic 36-item questionnaire measuring health-related quality of life (HRQL) having 2 measures: physical component summary (PCS) and mental component summary (MCS). It consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.

    Measured: Baseline, Week 16, 28, 36 and 48

  12. Change From Baseline in Work Productivity and Activity Impairment (WPAI): Psoriasis (PSO) Over Time

    Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. This instrument generates four scores between 0 and 100: absenteeism (work time missed), presenteeism (impairment at work / reduced productivity while working), work productivity loss (overall work impairment /absenteeism plus presenteeism) and activity impairment, which were expressed in percentage of impairment.

    Measured: Baseline, Week 16, 28, 36 and 48

  13. Observed Serum Guselkumab Concentrations

    Measured: Baseline, Pre-dose on Week 4, 8, 12, 16, 20, 24, 28, 36, 44, 48 and 52

  14. Number of Participants With Guselkumab Antibodies

    Measured: Baseline, Pre-dose on Week 4, 16, 28, 48 and 52

Timeline

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

  1. First posted22 Jan 2015 (estimated)
  2. Study start19 Jan 2015
  3. Primary completion4 Dec 2015
  4. Study completion2 Nov 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02343744
Sponsor's protocol ID
CR104128
Other IDs
CNTO1959PSO3005
Status last verified
Oct 2019
First submitted
16 Jan 2015
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guselkumab in people with Pustular Psoriasis, run by Janssen Pharmaceutical K.K. at 20 sites in Japan.

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 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 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants with Treatment Success at Week16 (time frame: Week 16). 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 NCT02343744.

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 24 Oct 2019.

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