Palmoplantar PustulosisPhase 3NCT04061252

A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

A Phase 3 study testing KHK4827 in people with Palmoplantar Pustulosis, run by Kyowa Kirin Co., Ltd. at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Palmoplantar Pustulosis
What is being tested?: KHK4827
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 126 participants
Where: 2 sitesJapan
Study dates: 10 Aug 2019to 5 Aug 2022
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has had a diagnosis of palmoplantar pustulosis for at least 24 weeks as of the time of informed consent.
Subject has a PPPASI total score ≥12 and a PPPASI severity score of pustules/vesicles on the palms or soles ≥2 both at the pre-examination and enrollment examination;
Subject inadequately responded to any one or combination of the following therapies before informed consent: Topical corticosteroids, Topical vitamin D3, Phototherapy, Etretinate

Who cannot join

Subject has a diagnosis of plaque psoriasis, pustular psoriasis, drug-induced palmoplantar pustulosis, or pompholyx;
Subject has an improvement in PPPASI total score of ≥4 points during the screening period;
Subject has a history or evidence of psychiatric disorder or alcohol/drug abuse that, in the opinion of the investigator or subinvestigator, may compromise the safety of the subject because of participation in the study or may interfere with assessments and procedures in the study or study completion;
Subject has a past or current history of suicidal ideation (severity of 4 or 5) or any suicidal behavior at enrollment, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS);
Subject has severe depression with a PHQ-8 total score of ≥15 at enrollment

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Takagi Dermatology clinic
Obihiro, Hokkaido
Sapporo Dermatology clinic
Sapporo, Hokkaido

Other trials in Japan

About this study

Official title: A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis

Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis

Conditions: Palmoplantar Pustulosis
Being tested: KHK4827, Placebo
Keywords: Palmoplantar Pustulosis, brodalumab, 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
brodalumab 210mg Q2W, SC
PlaceboDrug
Q2W, SC

Study groups in NCT04061252
Study group	Role	What they receive
KHK4827 210mg Q2W SC	Experimental	Not described Receives: Drug: KHK4827
Placebo Q2W 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.

Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16
PPPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. PPPASI is calculated by the following calculation formula.
PPPASI=(E+P+D) Area*0.2 (RP)+(E+P+D) Area*0.2 (LP)+ (E+P+D) Area*0.3 (RS)+(E+P+D) Area*0.3 (LS).
Measured: Baseline, Week 16

Secondary outcomes (7)

Change from baseline in Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16
(PPP-SI) total score at Week 16. PPP-SI assesses the severity of palmoplantar pustulosis skin lesions and response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
Measured: Baseline, Week 16
The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16
Measured: Week 16
The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16
Measured: Week 16
The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16
Measured: Week 16
Change from baseline in PPPASI total score at each assessment time point
Measured: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
Change from baseline in PPP-SI total score at each assessment time point
Measured: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
Change from baseline in Dermatology Life Quality Index (DLQI) score at each evaluation point
The DLQI is a skin disease-specific scale that assesses the impact of skin symptoms on QOL during the past 7 days and consists of 10 questions relating to "symptoms and feelings", "daily activities", "leisure", "work and employment", "personal relationship", and "treatment". The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease.
Measured: Baseline, Week 8, 16, 24, 32, 44, 56, 68

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 20195 Aug 2022

First posted19 Aug 2019
Study start10 Aug 2019
Primary completion11 Aug 2021
Study completion5 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Palmoplantar PustulosisStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04061252
Sponsor's protocol ID: 4827-009
Status last verified: Apr 2022
First submitted: 16 Jul 2019
Last updated: 14 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Nozaki T, Arai M, Ochi J, Uchida-Yamada M, Hashimoto M, Akiyama M, Kaneko Y, Kanai Y, Jinzaki M. Exploratory MRI and Clinical Marker Analysis of Pustulotic Arthro-Osteitis Disease Activity From a Phase 3 Brodalumab Trial. J Dermatol. 2026 Aug 2. doi: 10.1111/1346-8138.70425. Online ahead of print.
PubMed 42543660
Okubo Y, Kobayashi S, Murakami M, Sano S, Kikuta N, Ouchi Y, Terui T. Efficacy and Safety of Brodalumab, an Anti-interleukin-17 Receptor A Monoclonal Antibody, for Palmoplantar Pustulosis: 16-Week Results of a Randomized Clinical Trial. Am J Clin Dermatol. 2024 Sep;25(5):837-847. doi: 10.1007/s40257-024-00876-x. Epub 2024 Jul 2.
PubMed 38954226

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
Palmoplantar Pustulosis of Adults
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 2
A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis
Palmoplantar Pustulosis
Active, not recruitingObservational study
A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis
Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Generalized Pustular Psoriasis, Erythrodermic Psoriasis

All Palmoplantar Pustulosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis
ClinicalTrials.gov ID: NCT04061252
Acronym / sponsor ID: 4827-009
Conditions: Palmoplantar Pustulosis
Keywords: Palmoplantar Pustulosis, brodalumab, KHK4827
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Aug 2019 (actual)
Primary completion: 11 Aug 2021 (actual)
Study completion: 5 Aug 2022 (actual)
First posted: 19 Aug 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.

Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
KHK4827 210mg Q2W SC	Experimental	Drug: KHK4827
Placebo Q2W SC	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject has had a diagnosis of palmoplantar pustulosis for at least 24 weeks as of the time of informed consent.
Subject has a PPPASI total score ≥12 and a PPPASI severity score of pustules/vesicles on the palms or soles ≥2 both at the pre-examination and enrollment examination;
Subject inadequately responded to any one or combination of the following therapies before informed consent: Topical corticosteroids, Topical vitamin D3, Phototherapy, Etretinate

Key exclusion criteria (5 listed)

Subject has a diagnosis of plaque psoriasis, pustular psoriasis, drug-induced palmoplantar pustulosis, or pompholyx;
Subject has an improvement in PPPASI total score of ≥4 points during the screening period;
Subject has a history or evidence of psychiatric disorder or alcohol/drug abuse that, in the opinion of the investigator or subinvestigator, may compromise the safety of the subject because of participation in the study or may interfere with assessments and procedures in the study or study completion;
Subject has a past or current history of suicidal ideation (severity of 4 or 5) or any suicidal behavior at enrollment, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS);
Subject has severe depression with a PHQ-8 total score of ≥15 at enrollment

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
KHK4827brodalumab 210mg Q2W, SC	Drug	KHK4827 210mg Q2W SC
PlaceboQ2W, SC	Drug	Placebo Q2W SC

Primary outcome

Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16
Time frame: Baseline, Week 16
PPPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. PPPASI is calculated by the following calculation formula. PPPASI=(E+P+D) Area*0.2 (RP)+(E+P+D) Area*0.2 (LP)+ (E+P+D) Area*0.3 (RS)+(E+P+D) Area*0.3 (LS).

7 secondary outcomes

Change from baseline in Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16
Time frame: Baseline, Week 16
The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16
Time frame: Week 16
The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16
Time frame: Week 16
The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16
Time frame: Week 16
Change from baseline in PPPASI total score at each assessment time point
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
Change from baseline in PPP-SI total score at each assessment time point
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
Change from baseline in Dermatology Life Quality Index (DLQI) score at each evaluation point
Time frame: Baseline, Week 8, 16, 24, 32, 44, 56, 68

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 14 Feb 2023.
Derived from this study: PubMed 42543660Nozaki T, Arai M, Ochi J, Uchida-Yamada M, Hashimoto M, Akiyama M, Kaneko Y, Kanai Y, Jinzaki M. Exploratory MRI and Clinical Marker Analysis of Pustulotic Arthro-Osteitis Disease Activity From a Phase 3 Brodalumab Trial. J Dermatol. 2026 Aug 2. doi: 10.1111/1346-8138.70425. Online ahead of print.
Derived from this study: PubMed 38954226Okubo Y, Kobayashi S, Murakami M, Sano S, Kikuta N, Ouchi Y, Terui T. Efficacy and Safety of Brodalumab, an Anti-interleukin-17 Receptor A Monoclonal Antibody, for Palmoplantar Pustulosis: 16-Week Results of a Randomized Clinical Trial. Am J Clin Dermatol. 2024 Sep;25(5):837-847. doi: 10.1007/s40257-024-00876-x. Epub 2024 Jul 2.
Individual participant dataSharing planned: Undecided

Related trials for Palmoplantar Pustulosis

Not yet recruitingPhase 2
A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
Palmoplantar Pustulosis of Adults
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 2
A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis
Palmoplantar Pustulosis
Active, not recruitingObservational study
A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis
Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Generalized Pustular Psoriasis, Erythrodermic Psoriasis

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.

2 sites 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 Palmoplantar Pustulosis, run by Kyowa Kirin Co., Ltd. at 2 sites 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 5 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16 (time frame: Baseline, Week 16). 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 NCT04061252, which also lists 2 linked publications.

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 14 Feb 2023.