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Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis

NCT ID: NCT02896127

Last Updated: 2020-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

458 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-18

Study Completion Date

2019-03-19

Brief Summary

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The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of secukinumab compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety up to Week 52.

Detailed Description

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This multicenter study used a randomized, double-blind, placebo-controlled, parallel-group design. A screening period running up to 10 weeks before randomization was used to assess eligibility, followed by 52 weeks of treatment.

At baseline, subjects were randomized to one of the two treatment groups:

* Group 1: 300 subjects, secukinumab 150 mg (1 mL, 150 mg/mL) s.c. pre-filled syringes (PFS) at BSL, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4
* Group 2: 150 subjects, placebo (1 mL) s.c. PFS at BSL, Weeks 1, 2, 3, 4, 8, and 12, followed by secukinumab 150 mg (1 mL, 150 mg/mL) administration every four weeks starting at Week 16

The subjects were stratified at randomization according to the region (China and non-China). Approximately 70% of randomized subjects were from China (327 Chinese subjects) in order to evaluate the efficacy and safety in this subject population. No more than 30% TNFα inhibitor inadequate responders (TNF-IR) subjects were to be enrolled in the study.

Starting at Week 16, all subjects switched to open-label secukinumab 150 mg, including all placebo subjects; however, all subjects and investigators/site staff remained blinded to the original randomized treatment group assignment (150 mg vs placebo). Study treatment continued up to Week 48.

An end of treatment visit was done 4 weeks after last study treatment administration and a post treatment follow-up visit was done 12 weeks after last study treatment administration for all subjects (regardless of whether they completed the entire study as planned or discontinued prematurely).

Subjects were instructed in detail how to self-administer the s.c. injection using PFS. Each injection was administered into an appropriate injection site of the body (thighs, arms, or abdomen). All injections were performed at the study site. Site personnel administered the injections to subjects who were not able to, or felt insecure to self-administer. Rescue medication was not allowed until Week 20. However, subjects who were deemed by the investigator not to be benefiting from the study treatment based on safety and efficacy assessments or for any reason of their own accord were free to discontinue participation in the study at any time.

Conditions

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Ankylosing Spondyloarthritis

Keywords

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Ankylosing Spondyloarthritis Axial spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Secukinumab

Secukinumab 150 mg s.c.

Arm includes all patients who received at least 1 dose of study drug including placebo switchers at Week 16

Group Type EXPERIMENTAL

Secukinumab

Intervention Type DRUG

Induction: 4x 150 mg Secukinumab s.c. weekly

Maintenance: 150 mg Secukinumab s.c. monthly

All Subjects received blinded treatment weekly starting at baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until Week 16. At Week 16, Group 1 patients continued using secukinumab 150 mg and Group 2 patients started receiving secukinumab 150 mg dosing every four weeks. Treatment was provided open-label from Week 16 onward, as all patients took 150 mg s.c. every 4 weeks; however, subjects, investigators, and site staff remained blinded to initial randomized group assignment.

Placebo

Placebo s.c.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly

Interventions

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Secukinumab

Induction: 4x 150 mg Secukinumab s.c. weekly

Maintenance: 150 mg Secukinumab s.c. monthly

All Subjects received blinded treatment weekly starting at baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until Week 16. At Week 16, Group 1 patients continued using secukinumab 150 mg and Group 2 patients started receiving secukinumab 150 mg dosing every four weeks. Treatment was provided open-label from Week 16 onward, as all patients took 150 mg s.c. every 4 weeks; however, subjects, investigators, and site staff remained blinded to initial randomized group assignment.

Intervention Type DRUG

Placebo

Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly

Intervention Type DRUG

Other Intervention Names

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AIN457

Eligibility Criteria

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Inclusion Criteria

Male or non-pregnant, non-lactating female patients at least 18 years of age

Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS:

* Active AS assessed by BASDAI ≥4 (0-10) at Baseline
* Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at Baseline
* Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline Patients should have had inadequate response or failure to respond to at least 2 NSAIDs at an approved dose for a minimum of 4 weeks in total and a minimum of 2 weeks for each NSAID prior to randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance, toxicity or contraindications Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to randomization or have been intolerant to at least one administration of an anti-TNFα agent

Exclusion Criteria

* Chest X-ray or MRI with evidence of ongoing infectious or malignant process

* Patients taking high potency opioid analgesics
* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
* Pregnant or nursing (lactating) women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Hefei, Anhui, China

Site Status

Novartis Investigative Site

Hefei, Anhui, China

Site Status

Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status

Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status

Novartis Investigative Site

Xiamen, Fujian, China

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Wuhan, Hubei, China

Site Status

Novartis Investigative Site

Changsha, Hunan, China

Site Status

Novartis Investigative Site

Changsha, Hunan, China

Site Status

Novartis Investigative Site

Nanjing, Jiangsu, China

Site Status

Novartis Investigative Site

Taiyuan, Shanxi, China

Site Status

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status

Novartis Investigative Site

Ürümqi, Xinjiang, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Bengbu, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanxi Province, , China

Site Status

Novartis Investigative Site

Tianjin, , China

Site Status

Novartis Investigative Site

Zhejiang, , China

Site Status

Novartis Investigative Site

Zhenjiang, , China

Site Status

Novartis Investigative Site

Bruntál, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Ostrava, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Prague, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Prague, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Uherské Hradiště, , Czechia

Site Status

Novartis Investigative Site

Seoul, Seocho Gu, South Korea

Site Status

Novartis Investigative Site

Busan, , South Korea

Site Status

Novartis Investigative Site

Gwangju, , South Korea

Site Status

Novartis Investigative Site

Incheon, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Reading, Berkshire, United Kingdom

Site Status

Novartis Investigative Site

Bradford, West Yorkshire, United Kingdom

Site Status

Novartis Investigative Site

Bath, , United Kingdom

Site Status

Novartis Investigative Site

Doncaster, , United Kingdom

Site Status

Novartis Investigative Site

Hull, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Norwich, , United Kingdom

Site Status

Novartis Investigative Site

Southampton, , United Kingdom

Site Status

Novartis Investigative Site

Wigan, , United Kingdom

Site Status

Countries

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China Czechia South Korea United Kingdom

References

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Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

Reference Type DERIVED
PMID: 35305260 (View on PubMed)

van der Horst-Bruinsma I, Miceli-Richard C, Braun J, Marzo-Ortega H, Pavelka K, Kivitz AJ, Deodhar A, Bao W, Porter B, Pournara E. A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis. Rheumatol Ther. 2021 Dec;8(4):1775-1787. doi: 10.1007/s40744-021-00380-2. Epub 2021 Oct 7.

Reference Type DERIVED
PMID: 34618347 (View on PubMed)

Huang F, Sun F, Wan WG, Wu LJ, Dong LL, Zhang X, Kim TH, Sengupta R, Senolt L, Wang Y, Qiu HM, Porter B, Haemmerle S. Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5. Chin Med J (Engl). 2020 Nov 5;133(21):2521-2531. doi: 10.1097/CM9.0000000000001099.

Reference Type DERIVED
PMID: 32925287 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-005021-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457F2308

Identifier Type: -

Identifier Source: org_study_id