Brodalumab in Subjects with Psoriatic Arthritis
- Conditions
- Psoriatic ArthritisMedDRA version: 17.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-003554-25-GB
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 630
- Subject has provided informed consent
- Subject is = 18 years of age at time of screening
- Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria
- Subject has = 3 tender and = 3 swollen joints
- Subject has a history of intolerance or inadequate response to NSAIDs and/or DMARDs for psoriatic arthritis
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Other Medical Conditions:
- Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.
- Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Washouts or Other Treatments
- Subject has used commercially available or investigational biologic therapies for psoriasis and/or psoriatic arthritis as follows:
? anti-tumor necrosis factor (TNF) therapy within 2 months prior to investigational product initiation
? other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months prior to investigational product initiation
? anti-IL17 or anti-IL12/IL23 biologic therapy, including brodalumab, secukinumab, ixekizumab, ustekinumab, briakinumab at any time
? rituximab at any time
General
- Subject is currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to screening.
- Other investigational procedures while participating in this study are excluded.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
-Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia Suicide Severity Rating Scale (eC-SSRS) at screening or at baseline
-Subject has a history or evidence of a psychiatric disorder or substance abuse that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
-Subject has severe depression based on a total score of = 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or baseline (note: subjects with a total score of 10-14 on the PHQ-8 should referred to a mental health professional).
- Women of reproductive potential who are not willing to use an acceptable form of birth control during the study and for an additional 8 weeks after the last dose of study drug.
- Women who are lactating/breastfeeding or planning to breastfeed during the study and for an additional 8 weeks after the last dose of Amgen study drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of brodalumab, (210 mg every 2 weeks (Q2W); and 140 mg Q2W) compared to placebo, in subjects with psoriatic arthritis, as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response at week 16.;Secondary Objective: Key Secondary Objectives:<br>To evaluate the efficacy of brodalumab compared to placebo on the following:<br>? Psoriasis Area and Severity Index (PASI) 75 at week 16<br>? Van der Heijde modified Total Sharp score (mTSS) at week 24;Primary end point(s): ACR20 response at week 16;Timepoint(s) of evaluation of this end point: Week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Key secondary Endpoints:<br>PASI 75 at week 16<br>mTSS change from baseline at week 24;Timepoint(s) of evaluation of this end point: PASI 75 at week 16<br>mTSS change from baseline at week 24