A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis.

Active, not recruiting

• Conditions: Psoriasis; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2006-006601-83-DK
• Lead Sponsor: Schering-Plough Research Institute, a division of Schering Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

? Subjects must have a diagnosis of psoriasis vulgaris (PASI >8) which must be established and must have been present for at least 1 year. Subjects with an on-therapy PASI =8 at Screening may be considered for inclusion. These subjects must be discussed with the Sponsor prior to enrollment and the subject must have indicated that they are not satisfied and are considering changing their current therapy. To be included, subjects must have a PASI >8 following washout of their current psoriasis therapy.
? The target lesion selected must be located on the head, trunk, arms or legs and be at least 10 cm^2 in size.
? The selected target lesion’s total numerical ratings for erythema, infiltration, and desquamation must be at least 6 out of the possible 12 using the following definitions for each sign: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The severity score for desquamation must be at least 2.
? Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges:
a. oral body temperature between 35.0 C to 37.5 C
b. systolic blood pressure, 90 to 160 mm Hg
c. diastolic blood pressure, 45 to 90 mm Hg
d. pulse rate, 40 to 100 bpm
? Subjects must have stable disease (ie, the off treatment PASI during Screening period and Baseline PASI should not differ by more than 40%).
? Subjects’ clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Subjects must have a neutrophil count of at least 2 x 10^9/L to be included.
? Subjects must be free of any clinically significant disease (other than psoriasis) that would interfere with the study evaluations and/or study safety.
? Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
? For females subjects:

Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Screening and have a negative urine pregnancy test throughout the study.

a. Women of childbearing potential must agree to use medically accepted methods of contraception during and for an appropriate pre-study period (hormonal contraceptives or IUD), while receiving protocol-specified medication, and for 1 month after stopping the medication.

Acceptable methods of contraception include 2 of the following:
oral/transdermal/injectable hormonal contraceptives, intrauterine device with spermicide, or hormonal estrogen/progesterone oral contraceptives.

A stable oral contraceptives regimen must have been used without uterine bleeding for 2 months prior to Screening. An intrauterine device must have been inserted at least 2 months prior to Screening. Females of childbearing potential should be counseled in the appropriate use of birth control while in this study and one additional method listed must also be used.

condoms (male or female) with spermicide,
diaphragm or cervical cap with spermicide,

Vasectomy of the partner should be considered a single barrier contraceptive and one additional contraceptive method listed above must be used.

Females who are not currently sexually active must agree and consent to use 2 of the above-mentioned methods should they become sexually active while participating in the study,

OR

b. Female subjects of non childbearing potential must be surgically sterilized (eg, documented hysterectomy or tubal ligation) or be postmenopausal (defined as 12 months with no menses and wit

Exclusion Criteria

? Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding.
? Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.
? Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following and be discussed with the sponsor prior to enrollment into the trial:
a. history or presence of inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding
b. history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
c. history of pancreatic injury or pancreatitis;
d. history or presence of liver disease or liver injury;
e. history or presence of impaired renal function as indicated by abnormal creatinine, urinary albumin, BUN/urea or clinically significant urinary cellular constituents (eg, cast); or
f. history of urinary obstruction or difficulty in voiding.
? Subject who has a history of any infectious disease within 4 weeks prior to drug administration.
? Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
? Immunocompromised subjects.
? Subjects who have a positive screen for drugs with a high potential for abuse (eg. opiates, cocaine, THC, etc).
? Subjects with a history of mental instability or who have been treated for mood disorders.
? Subjects with a history of alcohol or drug abuse in the past 2 years.
? Subjects who have previously received this compound.
? Subjects who are currently participating in another clinical study or have participated in a clinical study within 30 days.
? Subjects who are part of the study staff personnel or family members of the study staff personnel.
? Subjects who have demonstrated clinically significant (requiring intervention - eg, emergency room visit, epinephrine administration, etc) allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) or who are known to be allergic to components of local anesthetics, such as lidocaine.
? Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization. All prescription medications should be discussed with the sponsor to determine if they can be continued throughout the study.

Prohibited Medications

methotrexate, cyclosporine or systemic retinoids (washout prior to randomization – 4 weeks)
Biologics (washout prior to randomization – 3 months)
Topical anti-psoriasis therapy (washout prior to randomization – 2 weeks)
Phototherapy (washout prior to randomization – 4 weeks)
All other OTC medications (excluding paracetamol) including vitamins, herbal supplements, homeopathic or over the counter medications (washout prior to randomization – 2 weeks)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the clinical effect of SCH 527123 on the Psoriasis Activity and Severity Index (PASI) in patients with psoriasis. ;Secondary Objective: (1) To investigate the effects of SCH 527123 on the Physician's Global Assessment (PGA) of psoriasis activity;<br>(2) To investigate the safety and tolerability of SCH 527123 in psoriatic patients; <br>(3) To determine the multiple-dose pharmacokinetics of SCH 527123 in patients with psoriasis.;Primary end point(s): The primary endpoint of this study will be the percent change from baseline to Day 29 PASI score. Mean percent change from Baseline in Day 29 PASI score for each treatment will be compared using a one-way ANOVA model extracting the effect due to treatment. The mean and 95% confidence intervals will be provided for each treatment group as well as the difference between SCH 527123 and placebo. The last post-baseline observation will be carried forward for subjects who withdraw from the study.<br><br>