Brodalumab in Subjects with Psoriatic Arthritis

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2013-003554-25-GB
• Date of registration: 05/02/2014
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: Brodalumab in Subjects with Psoriatic Arthritis
• Scientific title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects with Psoriatic Arthritis: AMVISION-1 - AMVISION-1
• Date of first enrolment: 12/03/2014
• Target sample size: 630
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003554-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: randomized, double-blind, placebo-controlled study with long term extension Number of treatment arms in the trial: 3

Countries of recruitment

Belgium, Bulgaria, Canada, Czech Republic, Estonia, France, Greece, Hungary, Italy, Mexico, Netherlands, Poland, Russian Federation, Slovakia, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- 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

Exclusion criteria:
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.






Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Psoriatic Arthritis
MedDRA version: 17.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Intervention(s)

Product Name: brodalumab (140 mg/ml)
Product Code: AMG 827
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: brodalumab
CAS Number: 1174395-19-7
Current Sponsor code: AMG 827
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 140-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: brodalumab (70mg/0.5ml)
Product Code: AMG 827
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: brodalumab
CAS Number: 1174395-19-7
Current Sponsor code: AMG 827
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 140-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

Primary end point(s): ACR20 response at week 16

Timepoint(s) of evaluation of this end point: Week 16

Secondary Objective: Key Secondary Objectives:
To evaluate the efficacy of brodalumab compared to placebo on the following:
? Psoriasis Area and Severity Index (PASI) 75 at week 16
? Van der Heijde modified Total Sharp score (mTSS) at week 24

Secondary Outcome(s)

Secondary end point(s): Key secondary Endpoints:
PASI 75 at week 16
mTSS change from baseline at week 24

Timepoint(s) of evaluation of this end point: PASI 75 at week 16
mTSS change from baseline at week 24

Secondary ID(s)

20090406

2013-003554-25-GR

Source(s) of Monetary Support

Amgen Inc