PsoriasisPhase 3NCT01782937
An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis
A Phase 3 study testing KHK4827 in people with Psoriasis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- KHK4827
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2013to Dec 2014
- 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 signed voluntarily the written informed consent form to participate in this study.
- Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma.
- Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
Who cannot join
- Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion < 80% at baseline.
- Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis.
- Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of KHK4827 on psoriasis.
- Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
- Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
- Subject has used Ultra Violet B (UVB) therapy within 14 days of the first dose or Ultra Violet A (UVA) (with or without psoralen) within 28 days of the first dose.
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- Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively.
- Subject has stopped ustekinumab or other anti-Interleukin (IL)-23 biologics therapy due to lack of efficacy
- Subject has used live vaccine within 3 months of the first dose
- Subject has previously used an anti-IL-17 biologic therapy
Trial locations and contacts
1 site in 1 country.
Japan1 site
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, 100-8185
About this study
Official title: A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.
- Conditions
- Psoriasis
- Being tested
- KHK4827
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4827Drug
140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)
| Study group | Role | What they receive |
|---|---|---|
| KHK4827 | Experimental | Not described Receives: Drug: KHK4827 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression (CGI)
CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened
Measured: 52 weeks
Secondary outcomes (10)
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
Measured: 52 weeks
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
Measured: 52 weeks
Pustular symptom score (only in subjects with pustular psoriasis)
Measured: 52 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma)
Measured: 52 weeks
sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)
Measured: 52 weeks
Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)
Measured: 52 weeks
Incidence and types of adverse events and adverse reactions
Measured: 52 weeks
Laboratory values and vital signs
Measured: 52 weeks
Profiles of pharmacokinetics
Concentration of KHK4827 in serum
Measured: 52 weeks
Development of anti-KHK4827 antibody
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782937
- Sponsor's protocol ID
- 4827-004
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2013
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
- ClinicalTrials.gov ID
- NCT01782937
- Acronym / sponsor ID
- 4827-004
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KHK4827 | Experimental | Drug: KHK4827 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has signed voluntarily the written informed consent form to participate in this study.
- Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma.
- Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
Key exclusion criteria (10 listed)
- Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion < 80% at baseline.
- Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis.
- Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of KHK4827 on psoriasis.
- Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
- Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHK4827140 mg (dosage may be increased to 210 mg in case of insufficient efficacy) | Drug | KHK4827 |
Primary outcome
Clinical Global Impression (CGI)
Time frame: 52 weeks
CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened
10 secondary outcomes
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
Time frame: 52 weeks
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
Time frame: 52 weeks
Pustular symptom score (only in subjects with pustular psoriasis)
Time frame: 52 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma)
Time frame: 52 weeks
sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)
Time frame: 52 weeks
Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)
Time frame: 52 weeks
Incidence and types of adverse events and adverse reactions
Time frame: 52 weeks
Laboratory values and vital signs
Time frame: 52 weeks
Profiles of pharmacokinetics
Time frame: 52 weeks
Development of anti-KHK4827 antibody
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KHK4827 in people with Psoriasis, 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 3 inclusion and 10 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 16 Feb 2015. 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?
Clinical Global Impression (CGI) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2015.