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

NCT01109940 | Completed Phase 2 Results

• 2 other identifiers: CAIN457A2209E12009-011591-30
• Study Type: interventional
• Target: 39
• Locations: 4 countries
• Sites: 15

Brief 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).

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis; IgG1K monoclonal antibody; Interleukin -17A neutralizing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Reported Positive Antibodies for Secukinumab

  Pre-dose, Week 0, 8, 24, 40 and Week 64

• Total Interleukin (IL)- 17A Concentration in Blood at Steady-State

  Pre-dose and at the end of infusion (up to 64 weeks)

• Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)

  At end of infusion (Week 64)

• Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)

  Pre-dose (Week 0)

Study Arms (1)

AIN457

EXPERIMENTAL

Biological: AIN457A

Interventions

AIN457A BIOLOGICAL

AIN457

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Novartis Investigative Site

Paradise Valley, Arizona, 85253, United States

Location

Novartis Investigative Site

Springfield, Illinois, 62703, United States

Location

Novartis Investigative Site

Springfield, Illinois, 62704, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73112, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Novartis Investigative Site

Jackson, Tennessee, 38305, United States

Location

Novartis Investigative Site

Knoxville, Tennessee, 37909, United States

Location

Novartis Investigative Site

Benbrook, Texas, 76126, United States

Location

Novartis Investigative Site

Spokane, Washington, 99204, United States

Location

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Hamburg, 22081, Germany

Location

Novartis Investigative Site

Herne, 44625, Germany

Location

Novartis Investigative Site

München, D-80639, Germany

Location

Novartis Investigative Site

Amsterdamn, DE, 1100, Netherlands

Location

Novartis Investigative Site

Newcastle upon Tyne, NE2 4HH, United Kingdom

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 24, 2021
• Results First Posted: June 24, 2021

Record last verified: 2021-06

Locations

NL (1); DE (4); GB (1); US (9)