Moderate to Severe Plaque PsoriasisPhase 4NCT04614298
A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 4 study testing KHK4827-Active in people with Moderate to Severe Plaque Psoriasis, run by Kyowa Kirin Co., Ltd. at 25 sites in China.
Trial summary
The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- KHK4827-Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 25 sitesChina
- Study dates
- Jan 2021to Nov 2022
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are ≥18 and ≤70 years of age at the time of signing the written informed consent form
- Those who have involved BSA (the percentage (%) of body surface area involved with lesion) ≥10%, PASI (Psoriasis Area and Severity Index) ≥12 and sPGA (static Physician's global assessment) ≥ 3 at screening and at baseline.
Who cannot join
- Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis
- Those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Site 01
Beijing
Site 03
Beijing
Site 04
Beijing
Site 10
Beijing
Site 11
Beijing
Site 12
Beijing
Site 21
Beijing
Site 07
Changchun
Site 13
Changchun
Site 14
Chongqing
Site 09
Hangzhou
Site 17
Hangzhou
Site 24
Hangzhou
Site 25
Nanjing
Site 02
Shanghai
Site 05
Shanghai
Site 08
Shanghai
Site 06
Tianjin
Site 22
Tianjin
Site 23
Ürümqi
Site 16
Wenzhou
Site 19
Wuhan
Site 20
Wuhan
Site 15
Xi'an
Site 18
Xi'an
About this study
Official title: A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis
The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- KHK4827-Active, KHK4827-Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4827-ActiveDrug
Single SC administration
KHK4827-PlaceboDrug
Single SC administration
| Study group | Role | What they receive |
|---|---|---|
| KHK4827 210 mg SC (Subcutaneous) | Experimental | Single SC administration Receives: Drug: KHK4827-Active |
| Placebo SC | Placebo comparator | Single SC administration Receives: Drug: KHK4827-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12
Measured: Week 12
Secondary outcomes (2)
To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12
Measured: Week 12
To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study startJan 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Due to the reconsideration of KHK4827's business in China, it. was decided to withdraw this clinical trial prior to enrollment of first participant.
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin China Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614298
- Sponsor's protocol ID
- 4827-CN001
- Status last verified
- Sep 2021
- First submitted
- 27 Oct 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04614298
- Acronym / sponsor ID
- 4827-CN001
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the reconsideration of KHK4827's business in China, it. was decided to withdraw this clinical trial prior to enrollment of first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin China Pharmaceutical Co., Ltd.
- Study start
- Jan 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 3 Nov 2020 (actual)
- 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 objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHK4827 210 mg SC (Subcutaneous) | Experimental | Drug: KHK4827-ActiveSingle SC administration |
| Placebo SC | Placebo comparator | Drug: KHK4827-PlaceboSingle SC administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those who are ≥18 and ≤70 years of age at the time of signing the written informed consent form
- Those who have involved BSA (the percentage (%) of body surface area involved with lesion) ≥10%, PASI (Psoriasis Area and Severity Index) ≥12 and sPGA (static Physician's global assessment) ≥ 3 at screening and at baseline.
Key exclusion criteria (2 listed)
- Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis
- Those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug.
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-ActiveSingle SC administration | Drug | KHK4827 210 mg SC (Subcutaneous) |
| KHK4827-PlaceboSingle SC administration | Drug | Placebo SC |
Primary outcome
To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12
Time frame: Week 12
2 secondary outcomes
To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12
Time frame: Week 12
To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12
Time frame: Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KHK4827-Active in people with Moderate to Severe Plaque Psoriasis, run by Kyowa Kirin Co., Ltd. at 25 sites in China.
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: withdrawn, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12 (time frame: Week 12). 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 30 Sep 2021.