Moderate to Severe Plaque PsoriasisPhase 3NCT02982005
A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea
A Phase 3 study testing KHK4827 in people with Moderate to Severe Plaque Psoriasis, run by Kyowa Kirin Korea Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- KHK4827
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to 14 Aug 2018
- 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 20 to 85 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 involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline
Who cannot join
- 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
Show all 13Show fewer
- 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 child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational 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"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Moderate to Severe Plaque Psoriasis
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
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- KHK4827, Placebo
- Keywords
- KHK4827 (brodalumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4827Drug
Also called Brodalumab
Administered KHK4827 by subcutaneous (SC) injection until week 62.
PlaceboDrug
Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.
| Study group | Role | What they receive |
|---|---|---|
| KHK4827 | Experimental | KHK4827 administered SC Receives: Drug: KHK4827 |
| Placebo | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis area and severity index (PASI) 75 response
Measured: at week 12
Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"
Measured: at week 12
Secondary outcomes (11)
PASI 50/75/90/100 response by visit
Measured: Baseline to week 64
sPGA of "0 (clear) or 1 (almost clear)" by visit
Measured: Baseline to week 64
Body surface area (BSA) involvement of lesion
Measured: Baseline to week 64
Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)
Measured: Baseline to week 64
Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)
Measured: Baseline to week 64
Dermatology life quality index (DLQI)
Measured: Baseline to week 64
Treatment-emergent adverse events (TEAEs) or drug-related TEAEs
Measured: Baseline to week 64
Laboratory values
Measured: Baseline to week 64
Vital signs
Measured: Baseline to week 64
Anti-KHK4827 antibodies
Measured: Baseline, Week 12, Week 24, Week 48, Week 64
Serum KHK4827 concentration
Measured: Baseline, Week 8, Week 10, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion14 Aug 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982005
- Sponsor's protocol ID
- 4827-KR001
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2016
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02982005
- Acronym / sponsor ID
- 4827-KR001
- Conditions
- Moderate to Severe Plaque Psoriasis
- Keywords
- KHK4827 (brodalumab)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kyowa Kirin Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 5 Dec 2016 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHK4827 | Experimental | Drug: KHK4827KHK4827 administered SC |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| KHK4827Also: BrodalumabAdministered KHK4827 by subcutaneous (SC) injection until week 62. | Drug | KHK4827 |
| PlaceboAdministered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62. | Drug | Placebo |
Primary outcome
Psoriasis area and severity index (PASI) 75 response
Time frame: at week 12
Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"
Time frame: at week 12
11 secondary outcomes
PASI 50/75/90/100 response by visit
Time frame: Baseline to week 64
sPGA of "0 (clear) or 1 (almost clear)" by visit
Time frame: Baseline to week 64
Body surface area (BSA) involvement of lesion
Time frame: Baseline to week 64
Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)
Time frame: Baseline to week 64
Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)
Time frame: Baseline to week 64
Dermatology life quality index (DLQI)
Time frame: Baseline to week 64
Treatment-emergent adverse events (TEAEs) or drug-related TEAEs
Time frame: Baseline to week 64
Laboratory values
Time frame: Baseline to week 64
Vital signs
Time frame: Baseline to week 64
Anti-KHK4827 antibodies
Time frame: Baseline, Week 12, Week 24, Week 48, Week 64
Serum KHK4827 concentration
Time frame: Baseline, Week 8, Week 10, Week 12, Week 24
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 29 Apr 2024.
- Individual participant dataSharing planned: No
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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 Moderate to Severe Plaque Psoriasis, run by Kyowa Kirin Korea Co., Ltd. at 1 site in South Korea.
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 13 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 29 Apr 2024. 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 South Korea. 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 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?
Psoriasis area and severity index (PASI) 75 response (time frame: at week 12). 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?
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 29 Apr 2024.