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Psoriasis VulgarisPhase 3NCT02052609

A Phase 3 Clinical Study of KHK 4827

A Phase 3 study testing KHK4827 140mg SC and KHK4827 210mg SC in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by Kyowa Kirin Co., Ltd. at 1 site 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

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KHK4827 140mg SC and KHK4827 210mg SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
1 siteJapan
Study dates
Feb 2014to 4 Jul 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • For additional information regarding investigative sites for this trial, contact Kyowa Kirin

    Chiyoda-ku, Tokyo, 100-8185

Other trials in Japan

About this study

Official title: An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

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).

Being tested
KHK4827 140mg SC, KHK4827 210mg SC
Medical subject headings
Arthritis, Psoriatic, Psoriasis

What participants receive

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

  • KHK4827 140mg SCDrug

    Experimental1:KHK4827 140mg subcutaneous injection

  • KHK4827 210mg SCDrug

    Experimental2:KHK4827 210mg subcutaneous injection

Study groups in NCT02052609
Study groupRoleWhat they receive
KHK4827 140mg SCExperimentalNot described
Receives: Drug: KHK4827 140mg SC
KHK4827 210mg SCExperimentalNot described
Receives: Drug: KHK4827 210mg SC

What is being measured

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

  1. Incidence and types of adverse events and adverse reactions

    Measured: 28 weeks

  2. Anti-KHK4827 antibody

    Measured: 28 weeks

Secondary outcomes (10)

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

    Measured: 28 weeks

  2. Percent improvement in PASI

    Measured: 28 Weeks

  3. PASI 50, 75, 90, and 100

    Measured: 28 Weeks

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

    Measured: 28 Weeks

  5. sPGA of "0 (clear)

    Measured: 28 weeks

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

    Measured: 28 weeks

  7. Clinical Global Impression (CGI)

    Measured: 28 weeks

  8. American College of Rheumatology (ACR) 20

    Measured: 28 weeks

  9. Pustular symptom score

    Measured: 28 weeks

  10. Serum KHK4827 concentration

    Measured: 28 weeks

Timeline

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

  1. First posted3 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completion28 Jan 2015
  4. Study completion4 Jul 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02052609
Sponsor's protocol ID
4827-005
Status last verified
Nov 2019
First submitted
30 Jan 2014
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KHK4827 140mg SC and KHK4827 210mg SC in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by Kyowa Kirin Co., Ltd. at 1 site 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 2 inclusion and 2 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 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Incidence and types of adverse events and adverse reactions (time frame: 28 weeks). The study lists 2 primary outcomes in all. 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 NCT02052609.

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 25 Aug 2023.

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