Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis

Axial Spondyloarthritis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Axial Spondyloarthritis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02429882
• Other study ID #: 20101228
• Secondary ID: 2014-003701-15
• Status: Withdrawn
• Phase: Phase 2
• First received: April 24, 2015
• Last updated: June 17, 2015
• Start date: May 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlFrance: Agence Nationale de Sécurité du Médicament et des produits de santéPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Agencia Española de Medicamentos y Productos SanitariosJapan: Pharmaceuticals and Medical Devices AgencyRussia: Ministry of Health of the Russian FederationRussia: Ethics CommitteeGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of brodalumab compared with placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1 ratio to brodalumab or placebo for the first part of the study. Subjects will then receive open label brodalumab for the remainder of the study. The entire study will be 312 weeks in duration for each subject.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject fulfills the ASAS classification criteria of axial spondyloarthritis (except Crohn's disease criterion) for > 3 months with age of onset < 45 years of age

• Subject has Bath Ankylosing Spondylitis DIsease Activity Index (BASDAI) score greater than or equal to 4 at screening and baseline

• Subject has spinal pain score (BASDAI question #2) greater than or equal to 4 at screening and baseline

• Subject has had adequate therapeutic trial (at least 4 weeks) of greater than or equal to 2 non-steroidal anti-inflammatory drgs (NSAIDs) at the maximum recommended dose unless contraindicated or subject is intolerant

• For subjects receiving non-biologic DMARDS subject has received treatment for greater than or equal to 3 months with a stable doe for greater than or equal to 4 weeks prior to initiation of IM

• For subjects receiving oral corticosteroids: the subject must be on a stable dose (not to exceed the equivalent of 10 mg of prednisone per day) for equal to or greater than 4 weeks prior to initiation of IMP

Exclusion Criteria:

• Complete ankylosis (fusion) of the spine; Subject has a positive test for tuberculosis

• Subject has a planned surgical intervention between baeline and week 16

• Subject has an active infection or history of infections as follows (any active infection for which systemic anti-infectives were used within 28 day prior to the first MP dose

• A serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose

• Recurrent or chronic infections or other active infection that, in the opinion ofthe investigator might cause this study to be detrimental to the subject)

• Subject has active Crohn's disease or a history of Crohn's disease

• Subject has active ulcerative colitis requiring daily use of immunosuppressive therapy

• Subject has had active fibromyalgia within the past 12 months

• Subject has a prior history of greater than 1 anti-TNF therapy for ankylosing spondylitis

• Subject has used commercially available or investigational biologic therapies for ankylosing spondylitis as follows

• Anti-tumor necrosis factor (TNF) therapy as follows: within 1 month prior to IMP initiation for etanercept and within 2 months prior to IMP initiation for other anti-TNF agents.

• Other experimental or commercially available biologic therapies for ankylosing spondylitis within 3 months prior to IMP initiation

• Anti-IL17 biologics (eg, brodalumab, secukinumab, ixekizumab) or anti-IL12/IL23 biologic therapy (eg, ustekinumab, briakinumab) at any time

• Rituximab at any time

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Drug:
• Brodalumab 210 mg
210 mg brodalumab will be administered subcutaneously
• Placebo
Placebo will be administered subcutaneously

Locations

Country	Name	City	State
Canada	Research Site	Winnipeg	Manitoba
Canada	Research Site	Winnipeg	Manitoba
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of SpondyloArthritis international Society (ASAS)	Achievement of Assessment of SpondyloArthritis international Society (ASAS) 20 response at week 16	Week 16	No

External Links

•   AmgenTrials clinical trials website