Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Moderate to Severe Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109940
• Other study ID #: CAIN457A2209E1
• Secondary ID: 2009-011591-30
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who took part and completed in the core CAIN457A2209 study

• Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or later could enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they fulfilled either one of the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were required to come for an additional baseline visit (Visit 17) and were required to fulfill either one of the criteria below:

• No improvement (compared with the core study baseline) in two out of the following four domains: patient global assessment, pain, BASFI and the mean of the two morning stiffness questions from the BASDAI. OR

• Deterioration (compared with the core study baseline) in one of the four domains (deterioration defined as >=20% worsening and an absolute worsening of >=1 unit)

Exclusion Criteria:

• Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.

• Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.

• Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16), and patients who completed the core study

• Pregnant or lactating women

• Presence of active infection

• Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• AIN457A

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Munchen
Netherlands	Novartis Investigative Site	Amsterdamn	DE
United Kingdom	Novartis Investigative Site	Newcastle upon Tyne
United States	Novartis Investigative Site	Benbrook	Texas
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Jackson	Tennessee
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Paradise Valley	Arizona
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Springfield	Illinois
United States	Novartis Investigative Site	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reported Adverse Events (AE's)	AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.	From start of the study up to 64 weeks
Secondary	Number of Participants Reported Positive Antibodies for Secukinumab	Immunogenicity (anti-drug antibodies) was assessed using an MSD bridging assay and a 3-tiered approach (screening, confirmation, titration).	Pre-dose, Week 0, 8, 24, 40 and Week 64
Secondary	Total Interleukin (IL)- 17A Concentration in Blood at Steady-State	Total serum IL17A was not measured due to assay limitations.	Pre-dose and at the end of infusion (up to 64 weeks)
Secondary	Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)	Concentration of Secukinumab at the end of infusion (Cmax,ss) was reported.	At end of infusion (Week 64)
Secondary	Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)	The concentration of secukinumab at pre-dose (Cmin,ss) in serum was reported.	Pre-dose (Week 0)