CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
AIN457 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00809159
NCT00809159Phase 2Completed

Randomized, Placebo Controlled Double Blind, Multi-center Phase II Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Moderate to Severe Ankylosing Spondylitis

Novartis Pharmaceuticals·interventional·Posted Dec 17, 2008·Updated Dec 9, 2015

In Brief

A Phase 2 clinical trial evaluating AIN457 and Placebo for Ankylosing Spondylitis. Completed, enrolled 60 participants across 20 sites in 4 countries.

Detailed Summary

Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as treatment of moderate to severe ankylosing spondylitis (AS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2008
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.5 years ago

Interventions

AIN457biological

AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.

Placebodrug

Placebo to AIN457