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CompletedNCT02052609Updated Aug 25, 2023

A Phase 3 Clinical Study of KHK 4827

A Phase 3 interventional study of KHK4827 140mg SC and KHK4827 210mg SC in Psoriasis Vulgaris, Psoriatic Arthritis and Pustular; Psoriasis, Palmaris Et Plantaris, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-25.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
155
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).

02

Conditions studied

  • Psoriasis Vulgaris
  • Psoriatic Arthritis
  • Pustular; Psoriasis, Palmaris Et Plantaris
  • Psoriatic Erythroderma
03

In context

Arthritis, Psoriatic

594 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.

This study's enrollment of 155 is above the median of 138 across 329 interventional studies indexed under Arthritis, Psoriatic.

Browse Arthritis, Psoriatic studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 9 are open to participants now.

Browse Kyowa Kirin Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject has voluntarily signed the written informed consent form to participate in this study
  • Subject has completed the week 52 evaluation either in Study 003 or 004

Exclusion criteria

Exclusion Criteria:

  • Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
  • Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    KHK4827 140mg SC

    Drug: KHK4827 140mg SC

  • Experimental
    KHK4827 210mg SC

    Drug: KHK4827 210mg SC

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence and types of adverse events and adverse reactions

    Time frame: 28 weeks

  2. Anti-KHK4827 antibody

    Time frame: 28 weeks

Secondary outcomes

  1. Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.

    Time frame: 28 weeks

  2. Percent improvement in PASI

    Time frame: 28 Weeks

  3. PASI 50, 75, 90, and 100

    Time frame: 28 Weeks

  4. Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"

    Time frame: 28 Weeks

  5. sPGA of "0 (clear)

    Time frame: 28 weeks

  6. Change in body surface area involvement (BSA) of lesion

    Time frame: 28 weeks

  7. Clinical Global Impression (CGI)

    Time frame: 28 weeks

  8. American College of Rheumatology (ACR) 20

    Time frame: 28 weeks

  9. Pustular symptom score

    Time frame: 28 weeks

  10. Serum KHK4827 concentration

    Time frame: 28 weeks

07

Study locations

1 site
  • For additional information regarding investigative sites for this trial, contact Kyowa Kirin
    Chiyoda-ku, Tokyo 100-8185, Japan
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014, a primary completion of Jan 2015 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2014
First posted
Feb 3, 2014
Start
Feb 2014
Primary completionActual
Jan 28, 2015
CompletionActual
Jul 4, 2016
Last update
Aug 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02052609
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Feb 3, 2014
Start date
Feb 2014
Primary completion
Jan 28, 2015
Completion
Jul 4, 2016
Last update
Aug 25, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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