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CompletedNCT02982005Updated Apr 29, 2024

A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea

A Phase 3 interventional study of KHK4827 and Placebo in Moderate to Severe Plaque Psoriasis, sponsored by Kyowa Kirin Korea Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Kyowa Kirin Korea Co., Ltd. (part of Kyowa Kirin Co., Ltd.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study summary

The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks

02

Conditions studied

  • Moderate to Severe Plaque Psoriasis

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Keywords

  • KHK4827 (brodalumab)
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 62 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Kyowa Kirin Korea Co., Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Browse Kyowa Kirin Korea Co., Ltd. studies →All Kyowa Kirin Co., Ltd. studies →

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

04

Who can participate

Ages eligible
20 Years to 85 Years
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 had stable moderate to severe plaque psoriasis for at least 6 months
  • Subject has involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline

Exclusion criteria

Exclusion Criteria:

  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations
  • Subject scheduled to undergo a surgical intervention during the study period
  • Subject has any active infection or history of infections as defined in the study protocol
  • Subject has known history of Crohn's disease
  • Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
  • Subject has not stopped using certain psoriasis therapies as defined in the study protocol
  • Subject has previously used any anti-IL-17 biologic therapy
  • Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study
  • Women of or fertile men who do not agree to use effective from the day of providing consent through 12 weeks after the last dose of product.
  • Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or at baseline
  • Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline
  • Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Subject has known history of alcohol and/or substance abuse within the last 12 months"
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    KHK4827

    KHK4827 administered SC

    Drug: KHK4827

  • Placebo comparator
    Placebo

    Placebo administered SC

    Drug: Placebo

Interventions

  • DrugKHK4827

    Administered KHK4827 by subcutaneous (SC) injection until week 62.

    Also known as: Brodalumab

  • DrugPlacebo

    Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.

06

What researchers measure

Primary outcomes

  1. Psoriasis area and severity index (PASI) 75 response

    Time frame: at week 12

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

    Time frame: at week 12

Secondary outcomes

  1. PASI 50/75/90/100 response by visit

    Time frame: Baseline to week 64

  2. sPGA of "0 (clear) or 1 (almost clear)" by visit

    Time frame: Baseline to week 64

  3. Body surface area (BSA) involvement of lesion

    Time frame: Baseline to week 64

  4. Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)

    Time frame: Baseline to week 64

  5. Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)

    Time frame: Baseline to week 64

  6. Dermatology life quality index (DLQI)

    Time frame: Baseline to week 64

  7. Treatment-emergent adverse events (TEAEs) or drug-related TEAEs

    Time frame: Baseline to week 64

  8. Laboratory values

    Time frame: Baseline to week 64

  9. Vital signs

    Time frame: Baseline to week 64

  10. Anti-KHK4827 antibodies

    Time frame: Baseline, Week 12, Week 24, Week 48, Week 64

  11. Serum KHK4827 concentration

    Time frame: Baseline, Week 8, Week 10, Week 12, Week 24

07

Study locations

1 site
  • Korea, Republic of
    Seoul, 49241, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

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

The record gives a start of Jan 2017, a primary completion of Aug 2018 and a completion of Aug 2018. 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
Dec 1, 2016
First posted
Dec 5, 2016
Start
Jan 2017
Primary completionActual
Aug 14, 2018
CompletionActual
Aug 14, 2018
Last update
Apr 29, 2024
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 Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02982005
Lead sponsor
Kyowa Kirin Korea Co., Ltd.
Responsible party
Sponsor
First posted
Dec 5, 2016
Start date
Jan 2017
Primary completion
Aug 14, 2018
Completion
Aug 14, 2018
Last update
Apr 29, 2024

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Brodalumab

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