Extension in AS: Sustainability of Benefits, Safety and Tolerability

Phase 3

Completed

• Conditions: Spondylitis, Ankylosing
• Interventions: Biological: Secukinumab; Other: Placebo (Pbo)

• Registration Number: NCT01863732
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-29
• Study Start: 2013-11-06
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Results First Submitted: 2019-03-13
• Status Verified: 2019-06
• Results First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Results First Posted: 2019-07-30
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

patients having completed the "core study" CAIN457F2305, indication for treatment extension. --

Exclusion Criteria

history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secukinumab (AIN457) 75mg Grp1	Secukinumab	Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 75 to 150mg Grp1	Secukinumab	Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
Secukinumab (AIN457) 75mg Grp1	Placebo (Pbo)	Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
Secukinumab (AIN457) 150mg Grp2	Secukinumab	Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 75mg Grp1	Secukinumab	Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W
Secukinumab (AIN457) 75 to 150mg Grp1	Secukinumab	Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
Secukinumab (AIN457) 150mg Grp2	Placebo (Pbo)	Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
Secukinumab (AIN457) 75 to 150mg Grp1	Placebo (Pbo)	Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 150mg Grp2	Placebo (Pbo)	Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 75mg Grp1	Placebo (Pbo)	Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 150mg Grp2	Secukinumab	Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
Pbo in Core then AIN457 75 to 150mg Grp1	Placebo (Pbo)	Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W

Primary Outcome Measures

Name	Time	Method
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260	Week 104 to Week 260	ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.

Secondary Outcome Measures

Name	Time	Method
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260	Week 104 to Week 260	ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Wolverhampton, United Kingdom