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

NCT01091051 | Terminated Phase 3

• 1 other identifier: Inno-6012
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

Brief 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)

Conditions

Palmo-Plantar Pustular Psoriasis; Palmo-Plantar Pustulosis

Keywords

Ustekinumab, Palmo-Plantar, Pustular Psoriasis, Pustulosis

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with PPPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo

  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.

  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

  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

  16 Weeks

• Changes from baseline in PPPASI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo

  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

  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

  baseline to 16 Weeks

Study Arms (2)

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

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

Drug: Placebo (Soduim Chloride)

Interventions

Ustekinumab DRUG

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

Ustekinumab

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Janssen-Ortho LLC: collaborator

Study Sites (8)

Kirk Barber Research

Calgary, Alberta, T2S3B3, Canada

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Eastern Canada Cutaneous Research Associates Ltd

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Lynderm Research

Markham, Ontario, L3P 1A8, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Centre de Recherches Dermatologiques du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Clinique Médicale Dr Isabelle Delorme

Saint-Hyacinthe, Quebec, J2S 6L6, Canada

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Simon Nigen, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 23, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

CA (8)