Dose Range Finding Study of Subcutaneous SCH900222 in Subjects with Moderate to Severe Chronic Psoriasis

Phase 1

• Conditions: Psoriasis; MedDRA version: 14.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2009-017272-24-BE
• Lead Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

A subject must meet all the criteria listed below to participate in the trial.
1. Ability to understand the purpose and risks of the trial, willingness and ability
to comply with the protocol, provide written informed consent in accordance
with institutional and regulatory guidelines, and, for subjects at US sites,
authorization to use protected health information (Health Insurance Portability
and Accountability Act [HIPAA]).
2. Subject must be =18 years of age. A subject may be of either sex and of any
race/ethnicity.
3. Diagnosis of predominantly plaque psoriasis for =6 months (as determined by
subject interview and confirmation of diagnosis through physical examination
by investigator).
4. Subject is considered to be a candidate for phototherapy or systemic therapy.
5. PASI score =12 at Baseline.
6. Psoriasis BSA involvement =10% at Baseline.
7. PGA of at least moderate disease (moderate, marked, or severe) at Baseline.
8. Subject is considered to be eligible according to the following tuberculosis
(TB) Screening criteria:
a. Has no history of untreated latent or active TB prior to Screening.
Prophylactic treatment for latent TB (as per local guidelines) must be
initiated at least 4 weeks prior to first administration of study medication.
b. Has no signs or symptoms suggestive of active TB upon medical
history and/or physical examination.
c. Has had no recent close contact with a person with active TB or, if
there has been such contact, will be referred to a physician
specializing in TB to undergo additional evaluation and, if warranted,
receive appropriate treatment for latent TB prior to or simultaneously
with the first administration of study medication.
d. Within 4 weeks prior to the first administration of study medication,
either has negative diagnostic TB test results (defined as a negative
tuberculin skin test or a negative QuantiFERON-TB Gold test.
e. A subject who has a positive intradermal skin test or positive
QuantiFERON gold TB test, or who has had recent close contact with
a person with active TB, or has signs or symptoms suggestive of active
TB upon medical history and/or physical examination, must have a
negative chest CT scan taken within 4 weeks of the first administration
of study medication. The scan must be read by a qualified radiologist,
and must have no evidence of current active TB or old inactive TB.
9. Subject is unlikely to conceive, as indicated by at least one yes” answer to
the following questions:
a. Subject is a male.
b. Subject is a surgically sterilized female.
c. Subject is a postmenopausal female =45 years of age with >1year
since last menses.
d. Subject is a non-sterilized, premenopausal female and agrees to
abstain from heterosexual activity OR use double barrier contraception
(ie, condom with spermicide or has a vasectomized partner PLUS oral,
intramuscular or implanted contraceptives, diaphragm with spermicide,
contraceptive sponge, intrauterine device [IUD]) OR use appropriate
double barrier contraception as per local regulations or guidelines.
10. For women of childbearing potential, a negative serum pregnancy test at
Screening and a negative urine pregnancy test within 24 hours prior to the
first dose of study medication.
11. Subject must have results of clinical laboratory tests (complete blood count
[CBC], blood chemistries, and urinalysis) within normal limits or clinically
acceptable to the investigator and medical monitor (or app

Exclusion Criteria

A subject meeting any of the exclusion criteria listed below must be excluded
from participating in the trial:
1. Presence of nonplaque forms of psoriasis specifically erythrodermic psoriasis,
predominantly pustular psoriasis, medication-induced or medicationexacerbated
psoriasis, or new onset guttate psoriasis.
2. Subject who will require oral or injectable corticosteroids during the trial.
3. Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint
infections) requiring hospitalization or treatment with IV antibiotics within
8 weeks prior to Screening.
4. Women of childbearing potential who are pregnant, intend to become
pregnant (within 6 months of completing the trial), or are lactating.
5. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface
antigen, or hepatitis C test result.
6. Prior malignancy or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma with no evidence of recurrence within 5 years, or carcinoma in situ of the cervix that has been adequately treated).
7. Subject who has received live virus vaccination within 4 weeks prior to
Baseline or who intends to receive live virus vaccination during the trial.
8. Previous exposure to any agents targeting IL-12 and/or IL-23.
9. Subject with prior exposure to two or more TNF antagonists with
discontinuation due to lack of efficacy.
10. Subject who is currently participating in another interventional clinical trial or
have participated in an interventional clinical trial within 4 weeks prior to
Screening. Note: Subjects participating in observational studies or noninterventional
registry studies may be included in the study.
11. The subject or a family member is among the personnel of the investigational
or sponsor staff directly involved with this trial.
12. Within 6 months prior to Screening, any significant organ dysfunction,
including cardiac (see below), renal, liver, central nervous system, pulmonary,
vascular, gastrointestinal, endocrine, psychiatric, ophthalmologic, or
metabolic conditions or clinically significant laboratory abnormalities that
place the subject at unacceptable risk for participation in a trial of an
immunomodulatory therapy in the judgment of the investigator and sponsor.
However, if the subject has significant organ dysfunction or exceeds the
ranges below, the investigator should confer with the medical monitor (or
appropriate designee) regarding study enrollment:
a. absolute neutrophil count <1500/mm3
b. platelet count <100,000/mm3
c. hemoglobin <11 g/dL
d. creatinine =1.5 x the upper limit of normal (ie, =133 µmol/L)
e. alanine transaminase (ALT [SGPT]) or aspartate transaminase (AST
[SGOT]) =2.5 x the upper limit of normal
13. History of myocardial infarction, congestive heart failure (New York Heart
Association [NYHA] Class 3 or 4), uncontrolled arrhythmias, cardiac
revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes
within 6 months of Screening.
14. Subject who, in the opinion of the investigator, will not be able to participate
optimally in the trial.
15. Subject with a history of alcohol or drug abuse in the previous 2 years.

16. Subject who has received any of the medications listed below within the
indicated washout period prior to randomizati

Study & Design

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