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

NCT02896127 | Completed Phase 3 Results

• 2 other identifiers: CAIN457F23082015-005021-39
• Study Type: interventional
• Target: 458
• Locations: 4 countries
• Sites: 44

Brief Summary

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.

Conditions

Ankylosing Spondyloarthritis

Keywords

Ankylosing Spondyloarthritis; Axial spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)

  ASAS20 response is defined as an improvement of ≥20% and ≥1 units on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain

  Week 16

Secondary Outcomes (7)

• The Proportion of Participants Who Achieve an ASAS40 Response

  The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.

• Change in hsCRP Over Time

  Change from baseline to Week 16. The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.

• Percentage of Participants Who Achieve an ASAS 5/6 at Week 16

  Week 16: The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.

• Participants With BASDAI Response at 16 Weeks

  The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.

• Change in Short Form (36) - PCS Responders (Improvement of >= 2.5 Points) at Week 16

  The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.

Study Arms (2)

Secukinumab

EXPERIMENTAL

Secukinumab 150 mg s.c. Arm includes all patients who received at least 1 dose of study drug including placebo switchers at Week 16

Drug: Secukinumab

Placebo

PLACEBO COMPARATOR

Placebo s.c.

Drug: Placebo

Interventions

Secukinumab 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.

Also known as: AIN457

Secukinumab

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (44)

Novartis Investigative Site

Hefei, Anhui, 230001, China

Location

Novartis Investigative Site

Hefei, Anhui, 230022, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100039, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

Location

Novartis Investigative Site

Xiamen, Fujian, 361001, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510000, China

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Novartis Investigative Site

Guangzhou, Guangdong, 51000, China

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Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Changsha, Hunan, 410008, China

Location

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

Location

Novartis Investigative Site

Taiyuan, Shanxi, 030001, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

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Novartis Investigative Site

Ürümqi, Xinjiang, 830001, China

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Novartis Investigative Site

Beijing, 100029, China

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Novartis Investigative Site

Bengbu, 233004, China

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Novartis Investigative Site

Shanghai, 200040, China

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Novartis Investigative Site

Shanghai, 200127, China

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Novartis Investigative Site

Shanghai, 200433, China

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Novartis Investigative Site

Shanghai, China

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Novartis Investigative Site

Shanxi Province, China

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Novartis Investigative Site

Tianjin, 300052, China

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Novartis Investigative Site

Zhejiang, China

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Novartis Investigative Site

Zhenjiang, China

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Novartis Investigative Site

Bruntál, Czech Republic, 792 01, Czechia

Location

Novartis Investigative Site

Ostrava, Czech Republic, 772 00, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 128 50, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 148 00, Czechia

Location

Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

Location

Novartis Investigative Site

Seoul, Seocho Gu, 06591, South Korea

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Novartis Investigative Site

Busan, 602739, South Korea

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Novartis Investigative Site

Gwangju, 61469, South Korea

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Novartis Investigative Site

Incheon, 405 760, South Korea

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Novartis Investigative Site

Seoul, 03080, South Korea

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Novartis Investigative Site

Seoul, 04763, South Korea

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Novartis Investigative Site

Reading, Berkshire, RG1 5AN, United Kingdom

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Novartis Investigative Site

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Novartis Investigative Site

Bath, BA1 1RL, United Kingdom

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Novartis Investigative Site

Doncaster, DN2 5LT, United Kingdom

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Novartis Investigative Site

Hull, HU16 5JQ, United Kingdom

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Novartis Investigative Site

London, NW1, United Kingdom

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Novartis Investigative Site

Norwich, NR1 3SR, United Kingdom

Location

Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

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Novartis Investigative Site

Wigan, WN6 9EP, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 35305260 DERIVED

• 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.

  PMID: 34618347 DERIVED

• 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.

  PMID: 32925287 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Lead
• Organization: Novartis PharmaAG

novartis.email@novartis.com

+41613241111

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: September 12, 2016
• Study Start: October 18, 2016
• Primary Completion: May 14, 2018
• Study Completion: March 19, 2019
• Last Updated: December 30, 2020
• Results First Posted: December 30, 2020

Record last verified: 2020-12

Locations

CN (24); KR (6); CZ (5); GB (9)