A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Psoriasis
- Conditions
- Moderate to severe plaque psoriasisMedDRA version: 12.0Level: LLTClassification code 10037153Term: Psoriasis
- Registration Number
- EUCTR2009-013539-39-FR
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 175
Subject is capable of understanding and giving written, voluntary informed consent before study screening.
Male or female = 18 and = 70 years of age at time of screening.
Subject has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
Subject has received at least 1 previous phototherapy or systemic psoriasis
therapy, ie, PUVA therapy, cyclosporine or methotrexate.
Subject has involved BSA = 10% and PASI = 12 at screening and at baseline.
Subject has a negative test for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, and HIV.
Subject has a negative serum pregnancy test within 28 days before initiating IP for female subjects (except those at least 3 years postmenopausal or surgically sterile) and a negative urine pregnancy test at baseline.
Subject has a negative purified protein derivative (PPD) test within 30 days prior to the first IP dose. Tuberculin skin tests should be considered positive when they have = 5 mm of induration at 48 to 72 hours after test is placed. Subjects with a positive tuberculin skin test (if = 14 mm of induration) may enroll if they have a history of Bacillus Calmette-Guerin vaccination with a negative Quantiferon test in the past year, no symptoms per tuberculosis worksheet, and a negative chest X-ray.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Skin disease related
Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
Other medical conditions
Subject has a planned surgical intervention for a pretreatment condition within the duration of the study, including the follow-up period.
Subject has any active CTCAE grade 2 (localized infection, local intervention indicated) or higher infection (including chronic or localized infections) within 30 days prior to screening, at screening, or during screening period prior to first IP dose.
Subject has a serious infection, defined as requiring hospitalization or IV antibiotics within 8 weeks before screening.
Subject has recurrent or chronic infections, defined as = 3 infections requiring anti-microbials over the past 12 months prior to screening.
Subject has a significant concurrent medical condition, including:
- Type 1 diabetes.
- Poorly controlled type 2 diabetes (Hemoglobin A1c > 8.5).
- Symptomatic heart failure (New York Heart Association class II, III, or IV).
- Myocardial infarction within the last year.
- Current or history of unstable angina pectoris within the last year.
- Uncontrolled hypertension as defined by resting blood pressure > 150/90 mmHg prior to randomization (confirmed by a repeat assessment).
- Severe chronic pulmonary disease (eg, requiring oxygen therapy).
- Major chronic inflammatory disease or connective tissue disease other than psoriasis with or without arthritis.
- Multiple sclerosis or any other demyelinating disease.
- Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin).
- Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the subject’s last study visit including the 30-day follow-up period.
Female subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study including the follow-up period (except women at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control for women include but are not limited to birth control pills, Depo-Provera® injections, contraceptive implants, or occlusive cap (barrier method) in combination with barrier methods used by the man.
Male subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study including the follow-up period, plus an additional 4 weeks (except for men who are surgically sterile or whose female partners are at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control include but are not limited to a condom in combination with hormonal birth control or barrier methods used by the woman.
Male subject (including vasectomised males) with a pregnant female partner is not willing to use effective methods to ensure that an unborn child is not exposed to AMG 827 via semen. Effective methods to ensure that an unborn child is not exposed to AMG 827 via semen include condoms or abstinence.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish a dose-response efficacy profile of AMG 827 compared with placebo as measured by the percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at week 12 and to identify an appropriate dose regimen for future trials.;Primary end point(s): Percent improvement from baseline in PASI at week 12;Secondary Objective: To evaluate the efficacy of AMG 827 as measured by the following:<br>- The proportion of subjects with a PASI 75 at week 12<br>- The proportion of subjects with a PASI 50, 90, and 100 at week 12<br>- The proportion of subjects with a static physician’s global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) at week 12<br>- Body surface area (BSA) involvement at weeks 12<br>To evaluate the short term safety profile of AMG 827 in subjects with moderate to severe psoriasis<br>To characterize the pharmacokinetics (PK) of AMG 827 in subjects with moderate to severe psoriasis
- Secondary Outcome Measures
Name Time Method