Palmoplantaris PustulosisPhase 2NCT01845987
A Study of the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody in Participants With Palmoplantar Pustulosis
A Phase 2 study testing CNTO 1959 in people with Palmoplantaris Pustulosis, run by Janssen Pharmaceutical K.K. at 8 sites in Japan.
Trial summary
The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Palmoplantaris Pustulosis
- What is being tested?
- CNTO 1959
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 8 sitesJapan
- Study dates
- Jun 2013to Sep 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has a diagnosis of palmoplantar pustulosis at screening (participants with concurrent extra-palmoplantar lesions [includes plaque-type psoriasis lesions] and/or pustulotic arthro-osteitis [PAO] can also be included)
- Participant has active lesions on the palms or soles at screening and baseline
- Participant has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate prior to or at screening
- Participant has a Palmoplantar Pustulosis Severity Index (PPSI) score of 7 or greater at screening and baseline
- At screening, the results of laboratory blood tests must be within protocol-specified limits
Who cannot join
- History of or current signs of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurologic, cerebral, or psychiatric disease
- Participant has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months prior to screening
- History of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (eg, recurrent pyelonephritis), fungal infection (eg, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- Participant has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months prior to screening
- Participant has or has had herpes zoster within the 2 months prior to screening
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Asahikawa
Study site
Fukuoka
Study site
Fukushima
Study site
Matsumoto
Study site
Sapporo
Study site
Sendai
Study site
Tokyo
Study site
Touon
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody, Following Subcutaneous Administration in Subjects With Palmoplantar Pustulosis
The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.
Read the detailed description
This will be a double-blind (participants and study personnel will not know the identity of the treatments given), multicenter study that is placebo-controlled (a placebo is identical to a study treatment, but has no active ingredients). Participants will be randomly assigned to 1 of 2 treatment groups (CNTO 1959 or placebo). The total duration of participation will be approximately 30 weeks, including a screening period of about 6 weeks before dosing. Participant safety will be monitored throughout the study.
- Conditions
- Palmoplantaris Pustulosis
- Being tested
- Placebo, CNTO 1959
- Keywords
- Palmoplantaris Pustulosis, CNTO 1959, Psoriasis, Anti-IL 23 Monoclonal Antibody
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
CNTO 1959Drug
CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CNTO 1959 | Experimental | Not described Receives: Drug: CNTO 1959 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PPSI total score at Week 16.
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
Measured: Baseline to Week 16
Secondary outcomes (11)
Change from baseline in PPSI total score over time
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
Measured: Baseline up to 24 weeks
Change from baseline in PPPASI total score
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 72, with higher scores indicating more severity.
Measured: Baseline up to 24 weeks
Proportion of participants who achieve a PPPASI-50
PPPASI-50 is at least 50% reduction in the PPPASI score.
Measured: Up to 24 weeks
Proportion of participants who achieve a PGA score of 1 or less
The Physician's Global Assessment (PGA) is used to determine the participant's overall palmoplantar pustulosis lesions, at a given time point. Scores can range from 0 (clear) to 5 (very severe).
Measured: Up to 24 weeks
Proportion of participants who achieve a PPPASI-75
PPPASI-75 is at least 75% reduction in the PPPASI score.
Measured: Up to 24 weeks
Change from baseline in PA (each score)
The Physician's Assessment (PA) is used to determine the participant's pustule, vesicle, and nail lesions at a given time point. Scores can range from 0 (clear) to 5 (very severe).
Measured: Baseline up to 24 weeks
Change from baseline in Patient's VAS-PPP severity
The Patient's Visual Analogue Scale (VAS) assessment of palmoplantar pustulosis severity will be recorded on a 10-cm VAS.
Measured: Baseline up to 24 weeks
Change from baseline in Physician's VAS-PAO activity
Physician's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity will be recorded on a 10-cm VAS.
Measured: Baseline up to 24 weeks
Change from baseline in Patient's VAS-PAO activity and pain
Patient's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity and Pain will be recorded on each 10-cm VAS.
Measured: Baseline up to 24 weeks
Change from baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item questionnaire that in addition to evaluating overall quality of life (QOL), can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Measured: Baseline up to 24 weeks
Change form baseline in SF-36 score
The 36-Item Short Form Health Survey (SF-36) consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception.
Measured: Baseline up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palmoplantaris PustulosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845987
- Sponsor's protocol ID
- CR100950
- Other IDs
- CNTO1959PPP2001
- Status last verified
- Oct 2015
- First submitted
- 30 Apr 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Terui T, Kobayashi S, Okubo Y, Murakami M, Hirose K, Kubo H. Efficacy and Safety of Guselkumab, an Anti-interleukin 23 Monoclonal Antibody, for Palmoplantar Pustulosis: A Randomized Clinical Trial. JAMA Dermatol. 2018 Mar 1;154(3):309-316. doi: 10.1001/jamadermatol.2017.5937.
PubMed 29417135
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody, Following Subcutaneous Administration in Subjects With Palmoplantar Pustulosis
- ClinicalTrials.gov ID
- NCT01845987
- Acronym / sponsor ID
- CR100950
- Conditions
- Palmoplantaris Pustulosis
- Keywords
- Palmoplantaris Pustulosis, CNTO 1959, Psoriasis, Anti-IL 23 Monoclonal Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 May 2013 (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 purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.
Detailed description
This will be a double-blind (participants and study personnel will not know the identity of the treatments given), multicenter study that is placebo-controlled (a placebo is identical to a study treatment, but has no active ingredients). Participants will be randomly assigned to 1 of 2 treatment groups (CNTO 1959 or placebo). The total duration of participation will be approximately 30 weeks, including a screening period of about 6 weeks before dosing. Participant safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| CNTO 1959 | Experimental | Drug: CNTO 1959 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant has a diagnosis of palmoplantar pustulosis at screening (participants with concurrent extra-palmoplantar lesions [includes plaque-type psoriasis lesions] and/or pustulotic arthro-osteitis [PAO] can also be included)
- Participant has active lesions on the palms or soles at screening and baseline
- Participant has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate prior to or at screening
- Participant has a Palmoplantar Pustulosis Severity Index (PPSI) score of 7 or greater at screening and baseline
- At screening, the results of laboratory blood tests must be within protocol-specified limits
Key exclusion criteria (5 listed)
- History of or current signs of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurologic, cerebral, or psychiatric disease
- Participant has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months prior to screening
- History of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (eg, recurrent pyelonephritis), fungal infection (eg, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- Participant has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months prior to screening
- Participant has or has had herpes zoster within the 2 months prior to screening
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 |
|---|---|---|
| PlaceboPlacebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4 | Drug | Placebo |
| CNTO 1959CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4 | Drug | CNTO 1959 |
Primary outcome
Change from baseline in PPSI total score at Week 16.
Time frame: Baseline to Week 16
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
11 secondary outcomes
Change from baseline in PPSI total score over time
Time frame: Baseline up to 24 weeks
Change from baseline in PPPASI total score
Time frame: Baseline up to 24 weeks
Proportion of participants who achieve a PPPASI-50
Time frame: Up to 24 weeks
Proportion of participants who achieve a PGA score of 1 or less
Time frame: Up to 24 weeks
Proportion of participants who achieve a PPPASI-75
Time frame: Up to 24 weeks
Change from baseline in PA (each score)
Time frame: Baseline up to 24 weeks
Change from baseline in Patient's VAS-PPP severity
Time frame: Baseline up to 24 weeks
Change from baseline in Physician's VAS-PAO activity
Time frame: Baseline up to 24 weeks
Change from baseline in Patient's VAS-PAO activity and pain
Time frame: Baseline up to 24 weeks
Change from baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline up to 24 weeks
Change form baseline in SF-36 score
Time frame: Baseline up to 24 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 20 Nov 2015.
- Derived from this study: PubMed 29417135Terui T, Kobayashi S, Okubo Y, Murakami M, Hirose K, Kubo H. Efficacy and Safety of Guselkumab, an Anti-interleukin 23 Monoclonal Antibody, for Palmoplantar Pustulosis: A Randomized Clinical Trial. JAMA Dermatol. 2018 Mar 1;154(3):309-316. doi: 10.1001/jamadermatol.2017.5937.
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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.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNTO 1959 in people with Palmoplantaris Pustulosis, run by Janssen Pharmaceutical K.K. at 8 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 5 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 PPSI total score at Week 16. (time frame: Baseline to 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 NCT01845987, which also lists 1 linked publication.
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 20 Nov 2015.