A Study to Evaluate the Effectiveness of STELARA ™ (USTEKINUMAB) in the Treatment of Scalp Psoriasis

NCT01558310 | Unknown Phase 4

• 1 other identifier: CSI ScalpPsor 012011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp specific physician assessments. The study will include approximately 30 subjects.

Conditions

Scalp Psoriasis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• s-PGA ( Scalp specific Physician Global Assessment) at Week 12

  s-PGA (Scalp specific Physician Global Assessment) is a 7 point scale ranging from 0 (Clear = No signs of psoriasis ) to 6 (Severe = Very marked plaque elevation, scaling, and/or erythema)

  Week 12 (8 weeks after the second of two SC doses of ustekinumab)

Study Arms (2)

Group A

ACTIVE COMPARATOR

Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52.The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses

Drug: Ustekinumab; Drug: Placebo

Group B

PLACEBO COMPARATOR

Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses

Drug: Ustekinumab; Drug: Placebo

Interventions

Ustekinumab DRUG

Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses

Group A; Group B

Placebo DRUG

Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
• Be 18 years of age or older at the time of consent; may be male or female.
• Have had a diagnosis of plaque psoriasis at least 6 months prior to administration of study agent.
• Presence of moderate or severe psoriasis on the body other than the scalp.
• At least 30% of scalp affected with erythema, induration and desquamation and s-PGA score greater than or equal to 4.
• Be candidates for phototherapy or systemic treatment of psoriasis.
• Women of childbearing potential and all men must be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue use of such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent.
• Be able to adhere to protocol requirements and study visit schedule.
• Must agree not to receive a live virus or live bacterial vaccination during the trial and 12 months after last study injection.
• Must agree not to receive a BCG vaccination during the trial and up to 12 months after the last injection.
• Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
• Are considered eligible according to the following tuberculosis (TB) screening criteria:
• Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
• Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.

You may not qualify if:

• Have a chest radiograph (both posterior-anterior and lateral views), 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.
• Have screening laboratory test results within the following parameters:
• Hemoglobin \> 10g/dL
• White Blood Cells \> 3.5 x 109 /L
• Neutrophils \> 1.5 x 109 /L
• Platelets \> 100 X109 /L
• Serum Creatinine \< 1.5 mg/dL ( or 133 micromol/L )
• AST,ALT, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range for the laboratory conducting the test
• Subjects meeting any of the following criteria may not be enrolled in the study:
• Currently have non-plaque forms of psoriasis (erythrodermic, guttate, or pustular).
• Have current drug-induced psoriasis.
• Presence of any skin conditions ( including scalp) other than psoriasis that would interfere with evaluations of the effect of study agents.
• Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study.
• Have used any therapeutic agent targeted at reducing IL-12 and/or IL-23, including but not limited to ustekinumab and ABT -874.
• Have used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent, whatever is longer.

Sponsors & Collaborators

• Paul Steven Yamauchi, MD, PhD: lead
• Janssen Services, LLC: collaborator

Study Sites (1)

Clinical Science Institute

Santa Monica, California, 90404, United States

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

• PAUL S YAMAUCHI, MD,PhD

  Clinical Science Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PAUL S YAMAUCHI, MD,PhD

CONTACT

3108288887; paulyamauchi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Clinical Science Institute

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 20, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

US (1)