Palmo-Plantar Pustular PsoriasisPhase 3NCT01091051
Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
A Phase 3 study testing Ustekinumab in people with Palmo-Plantar Pustular Psoriasis and Palmo-Plantar Pustulosis, run by Innovaderm Research Inc. at 8 sites in Canada.
Trial summary
This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmo-Plantar Pustular Psoriasis, Palmo-Plantar Pustulosis
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 8 sitesCanada
- Study dates
- Mar 2010to Nov 2011
- 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
- Have had for at least 6 months either:
- Palmo-plantar pustular psoriasis defined as active palmo-plantar disease morphology suggestive of psoriasis with at least one plaque of typical psoriasis outside the palms and soles or a history of typical plaque psoriasis outside the palms and soles (cohort A) OR
- Palmo-plantar pustulosis defined as active palmo-plantar morphology suggestive of palmo-plantar pustulosis without lesions of psoriasis outside palms and soles and without a history of psoriasis (cohort B).
- PPPASI score of at least 8 on hands and/or feet and a PPPGA score of 3 (moderate) or 4 (severe) at Day 0
- Stable palmo-plantar pustular psoriasis or palmo-plantar pustulosis for the past 4 weeks
- Men or women 18 years of age or older at time of consent
Show all 23Show fewer
- Must be candidate for phototherapy and systemic therapy
- Unless surgically sterile (or at least 1 year post-menopausal for women), or abstinent, patient (male or female) is willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 12 months after the last drug administration. Effective method of contraception are:
- Condom with spermicide, sponge with spermicide, foams with spermicide, jellies with spermicide, diaphragm with spermicide
- Intra uterine device (IUD)
- Contraceptives (oral or parenteral)
- Nuvaring
- Vasectomy or vasectomised partner
- Surgically sterile or post-menopausal partner
- Same-sex partner
- Capable of giving informed consent and the consent must be obtained prior to any study related procedures
- Are considered eligible according to the following TB (Tuberculosis) screening criteria:
- Have no history of latent or active TB prior to screening Patients with latent TB discovered at screening are not eligible for this study, even if they receive isoniazide or rifampin prophylaxis.
- No signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- No recent close contact with a person with active TB or, if there was such contact, have a negative QuantiFERON-TB Gold test (or a negative tuberculin (less than 5mm) skin test when QuantiFERON-TB Gold is not available) and have been referred to a physician specializing in TB to undergo additional evaluation to rule out TB infection.
- Within 6 weeks prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test. For patients enrolled at sites that where QuantiFERON-TB Gold test is not available, have a negative tuberculin (less than 5mm) skin test.
- A chest radiograph (posterior-anterior as defined by site-specific requirements), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB
- Female patients of childbearing potential have had a negative serum pregnancy test at the screening visit
Who cannot join
- Have used topical steroids, topical tar preparations or other topical anti-psoriatic preparations within 2 weeks preceding Day 0 except for the following which is allowed- mild to moderate potency topical corticosteroids for the face, groin, axilla, genitalia and scalp as long as they are applied with gloves: hydrocortisone, desonide, hydrocortisone valerate
- Have presence of erythrodermic or generalized pustular psoriasis
- Have presence of acute forms of tinea pedis and other causes of pustular eruptions of palms and soles apart from PPPP or PPP based on clinical evaluation or evidence of any skin condition that would interfere with the evaluation of PPPP or PPP
- Have had, based on investigator's judgment, any significant infection within 30 days preceding Day 0
- Have used any investigational drugs within 4 weeks of Day 0 or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer
- Have used systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, or methotrexate within 4 weeks of Day 0
Show all 18Show fewer
- Have used any biologic such as alefacept, etanercept, adalimumab or infliximab within 12 weeks or 5 half-lives which ever is longer of Day 0
- Have received ultraviolet light therapy: UVB (Ultraviolet B), nbUVB (Narrow Band Ultraviolet B), PUVA (Psoralen Ultraviolet A), or tanning bed within 4 weeks of Day 0
- Have had any severe, progressive or uncontrolled renal, hepatic, endocrine, cardiac, gastrointestinal, pulmonary, neurologic, psychiatric, cerebral, hematologic medical condition
- Are known to be infected with hepatitis B, hepatitis C virus or Human Immunodeficiency Virus (HIV)
- Are currently treated for latent tuberculosis
- Have or have had a serious infection (eg: sepsis, pneumonia or pyelonephritis) or have been hospitalized or received IV (Intravenous) antibiotics for an infection during the 2 months prior to screening
- Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent)
- Have received within 3 months (within 1 year for BCG (Bacillus Calmette-Guérin) vaccination) prior to the first injection a live virus or bacterial vaccination. Patients must agree not to receive a live virus or bacterial vaccination during the trial or up to 12 months after the last study agent injection
- Have a clinically significant laboratory result that, in the opinion of the investigator, prevents ustekinumab administration for safety reasons
- Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study
- Are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
- Have known hypersensitivity to ustekinumab or any of its components
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Kirk Barber Research
Calgary, Alberta, T2S3B3
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia, B3H 1Z4
Lynderm Research
Markham, Ontario, L3P 1A8
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
Centre de Recherches Dermatologiques du Quebec Metropolitain
Québec, Quebec, G1V 4X7
Clinique Médicale Dr Isabelle Delorme
Saint-Hyacinthe, Quebec, J2S 6L6
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7
About this study
Official title: Safety and Efficacy of Ustekinumab in the Treatment of Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP)
Read the detailed description
Twenty patients with active Palmo-Plantar Pustular Psoriasis (cohort A) and twenty patients with active Palmo-Plantar Pustulosis (cohort B) will be included in this placebo-controlled double-blind study.Patients in each cohort will be randomized (1:1) to receive either ustekinumab S/C (Sub-Cutaneous) (45 mg for patients weighting 100 kg or less, and 90 mg for patients weighting more than 100 kg) or placebo.
Patients randomized to ustekinumab (10 with PPPP and 10 with PPP) will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20 whereas patients randomized to placebo (10 with PPPP and 10 with PPP) will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20.
Patients will be seen at screening, Day 0, Weeks 4, 8, 16, 20, 24 and 28. The PPPASI (Palmo-Plantar Pustular Area and Severity Index), PPPGA (Palmo-Plantar Physician Global Assessment), PPSA (Palmo-Plantar Surface Area) will be used to evaluate severity and DLQI (Dermatology Life Quality Index), WPAI:PSO (Work Productivity and Activity Impairement Questionnaire:Psoriasis) and PPQoLI (Palmo-Plantar Quality of Life Index)will be used to evaluate quality of life. Safety will be assessed by physical examinations, evaluation of adverse events and laboratory analyses.
High quality digital medical photographs of palms and soles will be taken at Day 0, Weeks 4, 16 and 28. In addition, one optional skin biopsy from a palm or a sole will be performed at Day 0 and Week 16 and pus will be collected from pustules on palms and/or soles at Day 0 and Week 16. Finally, blood will be collected at Day 0 for genetic analysis from every patient who consents to DNA blood sampling.
- Being tested
- Ustekinumab, Placebo (Soduim Chloride)
- Keywords
- Ustekinumab, Palmo-Plantar, Pustular Psoriasis, Pustulosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Patients randomized to ustekinumab (10 with PPPP and 10 with PPP) will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20
Placebo (Soduim Chloride)Drug
Patients randomized to placebo (10 with PPPP and 10 with PPP) will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20
| Study group | Role | What they receive |
|---|---|---|
| Ustekinumab | Active comparator | Ustekinumab S/C 45mg or 90mg depending on patient's weight or placebo injection. 10 with PPPP and 10 with PPP will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20 Receives: Drug: Ustekinumab |
| Placebo | Placebo comparator | Placebo S/C (Sodium Chloride). 10 with PPPP and 10 with PPP will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20 Receives: Drug: Placebo (Soduim Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with PPPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo
Measured: 16 week
Proportion of patients with PPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo.
Measured: 16 Weeks
Secondary outcomes (9)
Evaluation of safety of ustekinumab as compared to placebo by reporting the incidence rates of adverse events and serious adverse events in patient with PPPP
Measured: 28 Weeks
Proportion of patients with PPPP who reach PPPASI-75 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo
Measured: 16 Weeks
Changes from baseline in PPPASI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Measured: baseline to 16 Weeks
Changes from baseline in the PPPGA at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Measured: baseline to 16 Weeks
Changes from baseline in PPSA at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Measured: baseline to 16 Weeks
Changes from baseline in the DLQI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Measured: baseline to 16 Weeks
Changes from baseline in WPAI:PSO at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Measured: baseline to 16 weeks
Changes from baseline in PPQoLI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Measured: baseline to 16 Weeks
Changes from baseline in PPPP at Week 28 for patients randomized to ustekinumab as measured with the PPPASI, PPPGA, PPSA, DLQI, WPAI:PSO and PPQoLI.
Measured: baseline to 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2011
- Study completionNov 2011
Why it stopped: Manufacturer ceased to produce vials used for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmo-Plantar Pustular PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Ortho LLC
- Responsible party
- Sponsor
- Investigators
- Simon Nigen, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091051
- Sponsor's protocol ID
- Inno-6012
- Status last verified
- Jun 2013
- First submitted
- 18 Mar 2010
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ustekinumab in the Treatment of Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
- ClinicalTrials.gov ID
- NCT01091051
- Acronym / sponsor ID
- Inno-6012
- Keywords
- Ustekinumab, Palmo-Plantar, Pustular Psoriasis, Pustulosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manufacturer ceased to produce vials used for this study.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Janssen-Ortho LLC
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Mar 2010 (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.
This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP)
Detailed description
Twenty patients with active Palmo-Plantar Pustular Psoriasis (cohort A) and twenty patients with active Palmo-Plantar Pustulosis (cohort B) will be included in this placebo-controlled double-blind study.Patients in each cohort will be randomized (1:1) to receive either ustekinumab S/C (Sub-Cutaneous) (45 mg for patients weighting 100 kg or less, and 90 mg for patients weighting more than 100 kg) or placebo.
Patients randomized to ustekinumab (10 with PPPP and 10 with PPP) will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20 whereas patients randomized to placebo (10 with PPPP and 10 with PPP) will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20.
Patients will be seen at screening, Day 0, Weeks 4, 8, 16, 20, 24 and 28. The PPPASI (Palmo-Plantar Pustular Area and Severity Index), PPPGA (Palmo-Plantar Physician Global Assessment), PPSA (Palmo-Plantar Surface Area) will be used to evaluate severity and DLQI (Dermatology Life Quality Index), WPAI:PSO (Work Productivity and Activity Impairement Questionnaire:Psoriasis) and PPQoLI (Palmo-Plantar Quality of Life Index)will be used to evaluate quality of life. Safety will be assessed by physical examinations, evaluation of adverse events and laboratory analyses.
High quality digital medical photographs of palms and soles will be taken at Day 0, Weeks 4, 16 and 28. In addition, one optional skin biopsy from a palm or a sole will be performed at Day 0 and Week 16 and pus will be collected from pustules on palms and/or soles at Day 0 and Week 16. Finally, blood will be collected at Day 0 for genetic analysis from every patient who consents to DNA blood sampling.
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 |
|---|---|---|
| Ustekinumab | Active comparator | Drug: UstekinumabUstekinumab S/C 45mg or 90mg depending on patient's weight or placebo injection. 10 with PPPP and 10 with PPP will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20 |
| Placebo | Placebo comparator | Drug: Placebo (Soduim Chloride)Placebo S/C (Sodium Chloride). 10 with PPPP and 10 with PPP will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Have had for at least 6 months either:
- PPPASI score of at least 8 on hands and/or feet and a PPPGA score of 3 (moderate) or 4 (severe) at Day 0
- Stable palmo-plantar pustular psoriasis or palmo-plantar pustulosis for the past 4 weeks
- Men or women 18 years of age or older at time of consent
- Must be candidate for phototherapy and systemic therapy
Key exclusion criteria (18 listed)
- Have used topical steroids, topical tar preparations or other topical anti-psoriatic preparations within 2 weeks preceding Day 0 except for the following which is allowed- mild to moderate potency topical corticosteroids for the face, groin, axilla, genitalia and scalp as long as they are applied with gloves: hydrocortisone, desonide, hydrocortisone valerate
- Have presence of erythrodermic or generalized pustular psoriasis
- Have presence of acute forms of tinea pedis and other causes of pustular eruptions of palms and soles apart from PPPP or PPP based on clinical evaluation or evidence of any skin condition that would interfere with the evaluation of PPPP or PPP
- Have had, based on investigator's judgment, any significant infection within 30 days preceding Day 0
- Have used any investigational drugs within 4 weeks of Day 0 or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer
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 |
|---|---|---|
| UstekinumabPatients randomized to ustekinumab (10 with PPPP and 10 with PPP) will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20 | Drug | Ustekinumab |
| Placebo (Soduim Chloride)Patients randomized to placebo (10 with PPPP and 10 with PPP) will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20 | Drug | Placebo |
Primary outcome
Proportion of patients with PPPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo
Time frame: 16 week
Proportion of patients with PPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo.
Time frame: 16 Weeks
9 secondary outcomes
Evaluation of safety of ustekinumab as compared to placebo by reporting the incidence rates of adverse events and serious adverse events in patient with PPPP
Time frame: 28 Weeks
Proportion of patients with PPPP who reach PPPASI-75 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo
Time frame: 16 Weeks
Changes from baseline in PPPASI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Time frame: baseline to 16 Weeks
Changes from baseline in the PPPGA at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Time frame: baseline to 16 Weeks
Changes from baseline in PPSA at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Time frame: baseline to 16 Weeks
Changes from baseline in the DLQI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Time frame: baseline to 16 Weeks
Changes from baseline in WPAI:PSO at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Time frame: baseline to 16 weeks
Changes from baseline in PPQoLI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo
Time frame: baseline to 16 Weeks
Changes from baseline in PPPP at Week 28 for patients randomized to ustekinumab as measured with the PPPASI, PPPGA, PPSA, DLQI, WPAI:PSO and PPQoLI.
Time frame: baseline to 28 Weeks
Results and safety
The study was stopped early (reason given: Manufacturer ceased to produce vials used for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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.
Simon Nigen, MD principal investigator
Innovaderm Research Inc.
8 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 Ustekinumab in people with Palmo-Plantar Pustular Psoriasis and Palmo-Plantar Pustulosis, run by Innovaderm Research Inc. at 8 sites in Canada.
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 23 inclusion and 18 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: stopped early, as of the sponsor's last update on 11 Jun 2013. 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 Canada. 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 was stopped early (reason given: Manufacturer ceased to produce vials used for this study.). Results are not available in the source record.
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?
Proportion of patients with PPPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo (time frame: 16 week). 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 11 Jun 2013.