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Palmoplantar Pustulosis (PPP)Phase 3NCT04451720

Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis

A Phase 3 study testing Risankizumab in people with Palmoplantar Pustulosis (PPP), run by AbbVie at 39 sites in Japan.

Completed

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

Official record
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Trial summary

Palmoplantar pustulosis is a chronic inflammatory skin disease that causes repeated on and off symptoms like erythema (reddening, irritation), vesicle (swelling, cyst), pustules, scale, and crusts in palms and soles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palmoplantar Pustulosis (PPP)
What is being tested?
Risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
119 participants
Where
39 sitesJapan
Study dates
20 Jul 2020to 21 Nov 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stable moderate to severe Palmoplantar Pustulosis (PPP) with a Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score of >= 12 at the Screening and Baseline Visits.
  • Moderate or severe pustules/vesicles on at least one palm or sole (>= 2 PPPASI severity score) at the Screening and Baseline Visits.
  • Experienced inadequate response (or intolerant) to treatment with topical corticosteroids and/or vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate.

Who cannot join

  • History of active skin disease other than PPP which could interfere with the assessment of PPP.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Japan39 sites

  • St.Luke's International Hospital /ID# 219019

    Chuo-ku, Tokyo, 104-8560

  • Isonokami dermatological clinic /ID# 219023

    Daito-shi, Osaka, 574-0046

  • Fukushima Medical University Hospital /ID# 221639

    Fukushima, Fukushima, 960-1295

  • Gifu University Hospital /ID# 219109

    Gifu, Gifu, 501-1194

  • Ichinomiya Municipal Hospital /ID# 222581

    Ichinomiya-shi, Aichi-ken, 491-8558

  • Tokai University Hospital /ID# 220945

    Isehara-shi, Kanagawa, 259-1193

  • Ibaraki Prefectural Central Hospital /ID# 222712

    Kasama-shi, Ibaraki, 309-1793

  • Bito Dermatology Clinic /ID# 222750

    Kobe, Hyōgo, 651-0095

  • Dokkyo Medical University Saitama Medical Center /ID# 222526

    Koshigaya-shi, Saitama, 343-8555

  • Kurume University Hospital /ID# 222751

    Kurume-shi, Fukuoka, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine /ID# 221376

    Kyoto, Kyoto, 602-8566

  • National Hospital Organization Kyoto Medical Center /ID# 221772

    Kyoto, Kyoto, 612-8555

  • Shinshu University Hospital /ID# 221343

    Matsumoto-shi, Nagano, 390-8621

  • The Jikei University Hospital /ID# 218822

    Minato-ku, Tokyo, 105-8471

  • Mito Kyodo General Hospital /ID# 220799

    Mito, Ibaraki, 310-0015

  • Nagaoka Red Cross Hospital /ID# 221375

    Nagaoka-shi, Niigata, 940-2085

  • Nagasaki University Hospital /ID# 221141

    Nagasaki, Nagasaki, 852-8501

  • Chukyo Hospital /ID# 218894

    Nagoya, Aichi-ken, 457-8510

  • Nagoya City University Hospital /ID# 221258

    Nagoya, Aichi-ken, 467-8602

  • Kansai Medical University Kori Hospital /ID# 223096

    Neyagawa, Osaka, 572-8551

  • Meiwa Hospital /ID# 221633

    Nishinomiya-shi, Hyōgo, 663-8186

  • Takagi Dermatology Clinic /ID# 220896

    Obihiro-shi, Hokkaido, 080-0013

  • Ogaki Municipal Hospital /ID# 220801

    Ogaki-shi, Gifu, 503-8502

  • Osaka Metropolitan University Hospital /ID# 222012

    Osaka, Osaka, 545-8586

  • Kindai University Hospital /ID# 219022

    Osakasayama-shi, Osaka, 589-8511

  • National Hospital Organization Sagamihara National Hospital /ID# 219082

    Sagamihara-shi, Kanagawa, 252-0392

  • Kume Clinic /ID# 220869

    Sakai-shi, Osaka, 5938324

  • Toho University Sakura Medical Center /ID# 220858

    Sakura-shi, Chiba, 285-8741

  • Tohoku University Hospital /ID# 219017

    Sendai, Miyagi, 9808574

  • Dokkyo Medical University Hospital /ID# 221210

    Shimotsuga-gun, Tochigi, 321-0293

  • Tokyo Medical University Hospital /ID# 218893

    Shinjuku-ku, Tokyo, 160-0023

  • Seibo Hospital /ID# 221691

    Shinjuku-ku, Tokyo, 161-8521

  • Shizuoka Saiseikai Genaral Hospital /ID# 222427

    Shizuoka, Shizuoka, 422-8527

  • Teikyo University Hospital /ID# 221089

    tabashi City, Tokyo, 173-8606

  • Takamatsu Red Cross Hospital /ID# 221344

    Takamatsu, Kagawa-ken, 760-0017

  • Ehime University Hospital /ID# 221260

    Toon-shi, Ehime, 791-0295

  • Fujita Health University Hospital /ID# 221285

    Toyoake-shi, Aichi-ken, 470-1192

  • Mie University Hospital /ID# 221570

    Tsu, Mie-ken, 514-8507

  • Yokohama City University Hospital /ID# 220860

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

About this study

Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult Japanese Subjects With Moderate to Severe Palmoplantar Pustulosis

Palmoplantar pustulosis is a chronic inflammatory skin disease that causes repeated on and off symptoms like erythema (reddening, irritation), vesicle (swelling, cyst), pustules, scale, and crusts in palms and soles. This study evaluates how well risankizumab works compared to placebo (no medicine) to treat palmoplantar pustulosis. Study will assess change in Palmoplantar Pustulosis Area and Severity Index [PPPASI].

Risankizumab is an investigational drug being developed for the treatment of palmoplantar pustulosis. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given study drug and who will receive placebo (no medicine). Participants are randomly put into 1 of 2 groups, called treatment arms to receive risankizumab or placebo in period A. In period B, each group receives both risankizumab and placebo at different time intervals. Around 116 adult participants with palmoplantar pustulosis will be enrolled in approximately 39 sites across Japan.

Read more

Participants will receive subcutaneous (SC) injections of risankizumab or placebo at Week 0 and Week 4 (Period A). Beginning Week 16 (Period B), both the groups will receive risankizumab and placebo at different intervals. Total treatment duration is 56 weeks.

There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Risankizumab, Placebo
Keywords
Palmoplantar Pustulosis (PPP), Risankizumab, SKYRIZI
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisankizumabDrug

    Also called SKYRIZI, ABBV-066

    Subcutaneous (SC) injection

  • PlaceboDrug

    Subcutaneous (SC) injection

Study groups in NCT04451720
Study groupRoleWhat they receive
RisankizumabExperimentalIn Period A, participants will receive risankizumab dose A at Weeks 0 and 4. In Period B, participants will receive risankizumab dose A at Weeks 16, 28, 40 and 52, and also placebo at Weeks 20, 32, 44 and 56.
Receives: Drug: Risankizumab; Drug: Placebo
PlaceboExperimentalIn Period A, participants will receive placebo at Weeks 0 and 4. In period B, participants will receive risankizumab dose A at Weeks 16, 20,32,44 and 56. and also placebo at Weeks 28,40 and 52.
Receives: Drug: Risankizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score

    The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

    Measured: Baseline (Week 0) through Week 16

Secondary outcomes (2)

  1. Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50)

    The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

    Measured: Baseline (Week 0) through Week 16

  2. Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)

    The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

    Measured: Baseline (Week 0) through Week 16

Timeline

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

  1. First posted30 Jun 2020
  2. Study start20 Jul 2020
  3. Primary completion21 Nov 2022
  4. Study completion21 Nov 2022

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451720
Sponsor's protocol ID
M19-135
Status last verified
Dec 2022
First submitted
29 Jun 2020
Last updated
5 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab in people with Palmoplantar Pustulosis (PPP), run by AbbVie at 39 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 1 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 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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. 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 (time frame: Baseline (Week 0) through 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 NCT04451720.

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 Dec 2022.

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