A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis (Study P04481 AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00684593
First received: May 22, 2008
Last updated: September 24, 2013
Last verified: September 2013

May 22, 2008
September 24, 2013
June 2007
October 2007   (final data collection date for primary outcome measure)
Day 29 Psoriasis Activity and Severity Index (PASI) score [ Time Frame: The outcome was measured on Day 29. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00684593 on ClinicalTrials.gov Archive Site
  • Physician's Global Assessment (PGA) Evaluation [ Time Frame: During and up to 2 weeks following final dose. PGA was done at Screening, Baseline and Days 15, 29, and 43. ] [ Designated as safety issue: No ]
  • Pharmacokinetics of SCH 527123 [ Time Frame: Visits 8, 15, 22, 28 and 29 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis (Study P04481 AM1)(COMPLETED)
A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis

SCH 527123 was evaluated as potential therapy for Psoriasis. This study was conducted using only patients with psoriasis. It assessed the clinical effect of SCH 527123 on the Psoriasis Activity and Severity Index (PASI), the effects on the Physician's Global Assessment (PGA), the safety and tolerability of SCH 527123, and, lastly, determined the multiple-dose pharmacokinetics of SCH 527123.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: SCH 527123
    SCH 527123, 10 mg capsules. Three capsules to be administered orally with 240 mL water. Duration of treatment 28 days.
    Other Name: SCH 527123
  • Other: Placebo matching SCH 527123
    Placebo matching SCH 527123, 10mg capsules. Three capsules to be administered orally with 240 mL water. Duration of treatment 28 days.
    Other Name: Placebo
  • Experimental: Arm 1
    SCH 527123, 10 mg capsules.
    Intervention: Drug: SCH 527123
  • Placebo Comparator: Arm 2
    Placebo matching SCH 527123 10 mg.
    Intervention: Other: Placebo matching SCH 527123
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects, of either sex and of any race between the ages of 18 to 70 years, having a Body Mass Index (BMI) between 19 to 34, BMI = weight (kg)/height (m^2)
  • Must have a diagnosis of psoriasis vulgaris (PASI >8) present for at least 1 year. Subjects with an on-therapy PASI <=8 at Screening may be considered for inclusion. Subjects must be discussed with the Sponsor prior to enrollment and the subject must have indicated that they are not satisfied with current therapy. To be included, subjects must have a PASI >8 following washout of their current psoriasis therapy
  • Target lesion selected must be located on the head, trunk, arms or legs and be at least 10 cm^2 in size. The lesion's total numerical ratings for erythema, infiltration, and desquamation must be at least 6 out of the possible 12. 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: oral body temperature between 35.0°C to 37.5°C; systolic blood pressure, 90 to 160 mm Hg; diastolic blood pressure, 45 to 90 mm Hg; pulse rate, 40 to 100 bpm
  • Have stable disease (ie, off treatment PASI during Screening period and Baseline PASI should not differ by more than 40%)
  • 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
  • Free of any clinically significant disease (other than psoriasis)
  • Willing to give written informed consent and able to adhere to dose and visit schedules.
  • For female subjects: Negative serum pregnancy test (beta-hCG) and urine pregnancy test. Agree to use medically accepted methods of contraception during and for an appropriate pre-study period while receiving protocol specified medication, and for 1 month after stopping medication. Female subjects of non-childbearing potential must be surgically sterilized or be postmenopausal
  • Male subject must agree to use an adequate form of contraception for the duration of the study
  • At Screening, ECG conduction intervals must be within gender specific normal range (ie, QTc for males <430 msec and females <450 msec) or if not within the normal range, the values must be considered clinically insignificant by the investigator and sponsor.

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
  • History of any infectious disease within 4 weeks prior to drug administration and/or are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV
  • Immunocompromised subjects
  • Positive screen for drugs with a high potential for abuse or have a history of drug or alcohol abuse in the past 2 years
  • History of mental instability or who have been treated for mood disorders
  • Donated blood in the past 60 days
  • Previously received this compound
  • Currently participating in another clinical study or have participated in a clinical study within 30 days
  • Part of the study staff personnel or family members of the study staff personnel
  • Demonstrated clinically significant (requiring intervention) allergic reactions or who are known to be allergic to components of local anesthetics
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00684593
P04481, EudraCT number: 2006-006601-83
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP