Moderate to Severe Plaque PsoriasisPhase 2NCT01748539
A Phase 2 Clinical Study of KHK4827
A Phase 2 study testing KHK4827 in people with Moderate to Severe Plaque Psoriasis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- KHK4827
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2012to Sep 2013
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has had stable moderate to severe plaque psoriasis for at least 6 months.
- 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.
- Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.
Who cannot join
- Subject diagnosed with erythrodermic psoriasis, pustular 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 investigational product 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 the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus
- , topical vitamin A, activated form D3 or activated form D3 analogue preparations, weak through strong topical steroids (excluding application on the scalp, axillae, and groin)
Show all 10Show fewer
- Subject has used the following therapies within 28 days of the first dose: any other systemic psoriasis therapy (eg, vitamin A, calcineurin inhibitors, methotrexates, steroids), UVA therapy (with or without psoralen), very strong or strongest topical steroid, tar therapy
- Subject has used the following therapies within 3 months of the first dose: adalimumab, etanercept, infliximab, or live vaccines
- Subject has used ustekinumab within 6 months of the first dose
- Subject has previously used an anti-interleukin-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
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis
This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- KHK4827, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4827Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KHK4827 70mg SC | Experimental | Not described Receives: Drug: KHK4827 |
| KHK4827 140mg SC | Experimental | Not described Receives: Drug: KHK4827 |
| KHK4827 210mg SC | Experimental | Not described Receives: Drug: KHK4827 |
| Placebo SC | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12
Measured: 12 weeks
Secondary outcomes (8)
PASI 75 at Week 12
Measured: 12 Weeks
PASI 50, 90 and 100 at Week 12
Measured: 12 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12
Measured: 12 Weeks
sPGA of "clear (0)" at Week 12
Measured: 12 weeks
Body surface area involvement (BSA) of lesion at Week 12
Measured: 12 weeks
American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12
Measured: 12 weeks
Incidence and types of adverse events and adverse reactions
Measured: 12 weeks
Profiles of Pharmacokinetics
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Plaque 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants (estimated)
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
- NCT01748539
- Sponsor's protocol ID
- 4827-002
- Status last verified
- Sep 2013
- First submitted
- 10 Dec 2012
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Nakagawa H, Niiro H, Ootaki K; Japanese brodalumab study group. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: Efficacy and safety results from a phase II randomized controlled study. J Dermatol Sci. 2016 Jan;81(1):44-52. doi: 10.1016/j.jdermsci.2015.10.009. Epub 2015 Oct 24.
PubMed 26547109
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01748539
- Acronym / sponsor ID
- 4827-002
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Dec 2012 (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 designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KHK4827 70mg SC | Experimental | Drug: KHK4827 |
| KHK4827 140mg SC | Experimental | Drug: KHK4827 |
| KHK4827 210mg SC | Experimental | Drug: KHK4827 |
| Placebo SC | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has had stable moderate to severe plaque psoriasis for at least 6 months.
- 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.
- Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.
Key exclusion criteria (10 listed)
- Subject diagnosed with erythrodermic psoriasis, pustular 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 investigational product 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 the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus
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 |
|---|---|---|
| KHK4827 | Drug | KHK4827 140mg SC, KHK4827 210mg SC, KHK4827 70mg SC |
| Placebo | Drug | Placebo SC |
Primary outcome
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12
Time frame: 12 weeks
8 secondary outcomes
PASI 75 at Week 12
Time frame: 12 Weeks
PASI 50, 90 and 100 at Week 12
Time frame: 12 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12
Time frame: 12 Weeks
sPGA of "clear (0)" at Week 12
Time frame: 12 weeks
Body surface area involvement (BSA) of lesion at Week 12
Time frame: 12 weeks
American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12
Time frame: 12 weeks
Incidence and types of adverse events and adverse reactions
Time frame: 12 weeks
Profiles of Pharmacokinetics
Time frame: 12 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 5 Sep 2013.
- Derived from this study: PubMed 26547109Nakagawa H, Niiro H, Ootaki K; Japanese brodalumab study group. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: Efficacy and safety results from a phase II randomized controlled study. J Dermatol Sci. 2016 Jan;81(1):44-52. doi: 10.1016/j.jdermsci.2015.10.009. Epub 2015 Oct 24.
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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 2 study testing KHK4827 in people with Moderate to Severe Plaque 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 5 Sep 2013. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 (time frame: 12 weeks). 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 NCT01748539, which also lists 1 linked publication.
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 5 Sep 2013.