Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01091051
• Date of registration: 18/03/2010
• Prospective Registration: No
• Primary sponsor: Innovaderm Research Inc.
• Public title: Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
• Scientific title: Safety and Efficacy of Ustekinumab in the Treatment of Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
• Date of first enrolment: March 2010
• Target sample size: 33
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01091051
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada

Contacts

• Name: Simon Nigen, MD
• Affiliation: Innovaderm Research Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Palmo-Plantar Pustular Psoriasis

Palmo-Plantar Pustulosis

Intervention(s)

Drug: Ustekinumab

Drug: Placebo (Soduim Chloride)

Primary Outcome(s)

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]

Secondary Outcome(s)

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 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 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]

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 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 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]

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]

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]

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]

Secondary ID(s)

Inno-6012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen-Ortho LLC