Psoriasis VulgarisPhase 4NCT04183881
A Phase 4 Clinical Study of Brodalumab
A Phase 4 study testing Brodalumab 210mg SC in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This study [4827-005 (post market)] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed Study 4827-003 (Study 003) and in subjects with pustular psoriasis (generalized) or psoriatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris
- What is being tested?
- Brodalumab 210mg SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteJapan
- Study dates
- 4 Jul 2016to 24 Jul 2017
- 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 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 study 4827-005 (phase 3)
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.
About this study
Official title: An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
This study [4827-005 (post market)] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) 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). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris, Psoriatic Erythroderma
- Being tested
- Brodalumab 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.
Brodalumab 210mg SCDrug
210 mg, subcutaneous dosing, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Brodalumab 210mg SC | Experimental | Brodalumab 210mg subcutaneous injection Receives: Drug: Brodalumab 210mg SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and types of adverse events and adverse reactions
Measured: 28 weeks
Anti-KHK4827 antibody
Measured: 28 weeks
Secondary outcomes (10)
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
Percent improvement in PASI
Measured: 28 weeks
PASI 50, 75, 90, and 100
Measured: 28 weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
Measured: 28 weeks
sPGA of "0 (clear)"
Measured: 28 weeks
Change in body surface area involvement (BSA) of lesion
Measured: 28 weeks
Clinical Global Impression (CGI)
Measured: 28 weeks
American College of Rheumatology (ACR) 20
Measured: 28 weeks
Pustular symptom score
This score indicate the severity of generalized pustular psoriasis (GPP). The severity of GPP (0:none-3:severe) is classified as mild(1), moderateor(2) severe(3) based on a total score after rating skin symptoms (erythema, pustules and edema) and systemic inflammation accom-panied by certain laboratory findings (fever, white blood cellcount, and serum CRP and albumin levels).
Measured: 28 weeks
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.
- First posted3 Dec 2019
- Study start4 Jul 2016
- Primary completion10 Jan 2017
- Study completion24 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 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
- NCT04183881
- Sponsor's protocol ID
- 4827-005 (post market)
- Status last verified
- Dec 2019
- First submitted
- 29 Nov 2019
- Last updated
- 9 Dec 2019
- 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 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
- ClinicalTrials.gov ID
- NCT04183881
- Acronym / sponsor ID
- 4827-005 (post market)
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris, Psoriatic Erythroderma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 3 Dec 2019 (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.
This study [4827-005 (post market)] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) 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). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brodalumab 210mg SC | Experimental | Drug: Brodalumab 210mg SCBrodalumab 210mg subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has voluntarily signed the written informed consent form to participate in this study
- Subject has completed the study 4827-005 (phase 3)
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Brodalumab 210mg SC210 mg, subcutaneous dosing, every 2 weeks | Drug | Brodalumab 210mg SC |
Primary outcome
Incidence and types of adverse events and adverse reactions
Time frame: 28 weeks
Anti-KHK4827 antibody
Time frame: 28 weeks
10 secondary outcomes
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
Time frame: 28 weeks
Percent improvement in PASI
Time frame: 28 weeks
PASI 50, 75, 90, and 100
Time frame: 28 weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
Time frame: 28 weeks
sPGA of "0 (clear)"
Time frame: 28 weeks
Change in body surface area involvement (BSA) of lesion
Time frame: 28 weeks
Clinical Global Impression (CGI)
Time frame: 28 weeks
American College of Rheumatology (ACR) 20
Time frame: 28 weeks
Pustular symptom score
Time frame: 28 weeks
Serum KHK4827 concentration
Time frame: 28 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 9 Dec 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brodalumab 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 9 Dec 2019. 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 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 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?
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 9 Dec 2019.